Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality after allogeneic hematopoietic cell transplantation (HCT). Acute GVHD is associated with severe physical and psychosocial symptoms. We sought to evaluate the feasibility of capturing patient-reported outcome (PRO) measures in acute GVHD to better measure symptom burden and quality of life (QOL). We conducted a pilot study of adult patients undergoing first allogeneic HCT. Questions from Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT), Patient-Reported Outcomes Measurement Information System (PROMIS-10), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were selected, and the survey was administered electronically before HCT, at days 14, 50, and 100 after HCT. In addition, patients who developed grade 2-4 acute GVHD received it weekly for 4 weeks and then monthly up to 3 months. From 2018 to 2020, 73 patients were consented, of which 66 went on to undergo HCT and were included in the analysis. Median age at transplantation was 63 years, and 92% were Caucasian. Only 47% of expected surveys were completed (range 0%67% for each time point). Descriptive exploratory analysis demonstrate an expected trajectory of QOL using the FACT-BMT and PROMIS-10 scores throughout transplantation. Patients who developed acute GVHD (N = 15) generally had lower QOL scores compared to those with no or mild GVHD post-HCT. The PRO-CTCAE captured several physical and mental/emotional symptoms in all patients and those with GVHD. Fatigue (100%), decreased appetite (92%), problem tasting (85%), loose stools (77%), pain (77%), skin itching (77%), and depression (feeling sad) (69%) were the most prevalent symptoms among patients with grade 2-4 acute GVHD. Patients with acute GVHD generally reported worse symptoms than those with no/mild GVHD in frequency, severity, and interference in normal activities. Several challenges were identified including poor access/literacy of electronic surveys, acute illness, and need for extensive research/resource support. We demonstrate the challenges yet potential of using PRO measures in acute GVHD. We demonstrate that the PROMIS-10 and PRO-CTCAE measures are able to capture several symptoms and QOL domains of acute GVHD. Further investigation into making PROs feasible in acute GVHD are needed.

Haploidentical (haplo) donor grafts are a well-established alternative donor source for allogeneic hematopoietic cell transplantation (HCT); however, data comparing health-realted quality of life (HRQOL) measures between haplo-HCT and HCT using other donor sources are lacking. We hypothesized that post-transplantation HRQOL might not differ between haplo-HCT and HCT with other graft sources. We conducted a single-institution retrospective analysis comparing HRQOL of haplo-HCT with matched-related donor (MRD) HCT and matched unrelated donor (MUD) HCT for hematologic diseases. We included 90 haplo, 102 MRD, and 229 MUD adult first allogeneic HCTs performed between May 2014 and December 2019. HRQOL for haplo-HCT, MRD-HCT, and MUD-HCT were compared separately for myeloablative conditioning (MAC) and reduced-intensity conditioning (MC). HRQOL was assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale pretransplantation and at days +100 and +180 post-transplantation. MAC haplo-HCT showed no difference in all domains of HRQOL and other transplantation outcomes, including overall survival, compared with MAC MRD/MUD-HCT, except for a higher incidence of non-cytomegalovirus infections (P = .003). RIC haplo-HCT was associated with significantly better emotional well-being (P = .008) and functional well-being (P = .011) compared with MUD-HCT. MC haplo-HCT was associated with higher rates of non-cytomegalovirus infections (P < .001) and relapse mortality (P = .044) but a lower rate of nonrelapse mortality (P = .008) compared with MC MUD-HCT. Haplo-HCT had comparable total HRQOL scores and overall survival to MRD/MUD-HCT in both the MAC and RIC cohorts. Interrogation of HRQOL among disease-specific groups may further elucidate the existence of any additional benefits with these different transplantation modalities. (C) 2022 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Background: Haploidentical (haplo) transplantation using post-transplant cyclophosphamide (Cy) based GVHD prophylaxis is a well-established alternative donor approach for allogeneic hematopoietic cell transplantation (HCT). Although outcomes from haplo HCT have been compared to matched related (MRD) and unrelated donor (MUD) allo HCT, quality-of-life (QOL) recovery between these transplant modalities has not been described. We hypothesized that post-transplant QOL is similar between Haplo and MRD/MUD grafts. A single-institution, retrospective cohort study was therefore conducted to compare outcomes including QOL between these groups. Methods: From May 2014 through December 2019, 90 haplo, 102 MRD and 229 MUD adult 1st allo HCTs were performed. Myeloablative conditioning (MAC) for haplo grafts (n=35) included fludarabine (Flu)/ total body irradiation (TBI) and reduced-intensity conditioning (RIC) haplo transplants (n=55) included Flu/Cy/TBI. QOL was assessed prior to transplant and at days +100 and +180 by the FACT-BMT which consisted of the following subdomains: "Physical well-being," "Social well-being," "Emotional well-being," "Functional well-being," "Additional concerns," and sum of all these subdomains as "Total score." Outcomes were estimated and compared with the Kaplan-Meier and log-rank test or cumulative incidence and Gray test. FACT-BMT scores were compared with repeated measures analysis of variance. Results: Patient and transplant characteristics were comparable among the donor sources except for higher median age at HCT in MUD transplants, and haplo grafts were more commonly used non-Caucasians, used RIC regimens and bone marrow grafts (Table 1). Median transplant hospital length of stay was longer for haplo vs. MRD vs. MUD grafts (31 vs.25 vs. 25 days, p<0.001) with longer median time until neutrophil and platelet recovery for haplo compared to MRD and MUD grafts (20 vs. 14 vs. 15 days, p<0.001, and 31 vs. 21 vs. 22 days, p<0.001, respectively). MAC haplo HCT had a higher incidence of CMV (p=0.05) and other infections (p=0.003), but no difference in other outcomes compared to MRD/MUD grafts, including all of the QOL domains. The mean Total scores from baseline to day +180 for haplo HCT were 157-157, MRD 153-166, and MUD HCT 152-163. RIC haplo HCT was associated with higher incidences of infections (p<0.001) and relapse mortality (p=0.04), but lower NRM (p=0.008) and no differences in other outcomes. When comparing RIC haplo to MUD transplants there was significantly better Emotional well-being (p=0.008) and Functional well-being (p=0.011) at day+180; respective mean emotional well-being score for haplo 19-23 and MUD 16-19; mean functional well-being score for haplo 19-24 and MRD 19-19 (Figures 1a and 1b). No difference for the other QOL measures were found; the mean Total scores from baseline to day +180 for haplo HCT were 155-180, and MUD HCT were 150-158 (p=0.25). Discussion: Among MAC recipients, we observed no differences in total FACT QOL scores and individual domains among haplo, MRD and MUD HCT recipients through 6 months post-HCT. After RIC HCT, haplo recipients reported better Emotional and Functional well-being compared to those receiving a MUD graft, although Total FACT score and other QOL domains were comparable through 6 months. Future strategies to lessen infectious complications and relapse may further improve QOL outcomes. Interrogation of QOL among disease specific groups may also elucidate whether additional benefits exist between these different transplant modalities. Disclosures Gerds: Sierra Oncology: Research Funding; Gilead Sciences: Research Funding; Celgene: Consultancy, Research Funding; Imago Biosciences: Research Funding; Roche/Genentech: Research Funding; Incyte Corporation: Consultancy, Research Funding; CTI Biopharma: Consultancy, Research Funding; Apexx Oncology: Consultancy; AstraZeneca/MedImmune: Consultancy; Pfizer: Research Funding. Hamilton:Syndax Pharmaceuticals: Consultancy, Honoraria. Majhail:Nkarta Therapeutics: Honoraria; Incyte: Honoraria; Mallinckrodt: Honoraria; Anthem, Inc.: Consultancy.

PROs are increasingly used in HCT to capture symptoms, quality of life, and functional status. At the Cleveland Clinic, PROs are systematically collected prior to ambulatory visits and used in routine clinical care to identify patients (pts) with distress in real-time through a data capture initiative called the "Knowledge Program." Instruments include the Patient Health Questionnaire (PHQ-9), National Comprehensive Cancer Network Distress Thermometer (DT), and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Health (PH) and Mental Health (MH) assessments. There are limited data on the use of these instruments in the HCT population. We evaluated these PRO measures in HCT recipients and their association with post-HCT outcomes.We identified 292 adult pts undergoing first allogeneic HCT from 2015-2018. Of those, 257 had at least one PRO assessment and were included in this analysis. Time intervals evaluated were: pre-HCT (within 3 months [mos]), 0-6 mos, 6-12 mos, 1-2 years (yrs), and 2-5 yrs post HCT. PHQ-9 assesses depression and categorized as minimal (score 0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). Higher DT scores indicate more distress and categorized as mild (0-3), moderate (4-7), severe (8-10). Lower scores on PROMIS indicate poorer PH or MH respectively. We evaluated PRO data descriptively for each time interval. Pre-HCT scores were analyzed for association with grade 2-4 acute graft-versus-host disease (GVHD), relapse, non-relapse mortality (NRM), and survival.Figure 1 shows boxplots for mean PHQ-9 and DT scores pre- and post-HCT. Mean scores for the PHQ-9 ranged from 1.1 ± 2.4 (SD) occurring >2 yrs post-HCT to 2.4 ± 3.0 pre-HCT. Mean DT scores were overall low, with highest distress (2.0 ± 2.2) seen pre-HCT. Mean scores for PH and MH were similar at each time intervals, with means ranging 47-48 for PH and 49-51 for MH. Higher PHQ-9 pre-HCT was associated with higher NRM (HR 1.21, 95% CI 1.09-1.34, P<0.001) and worse overall mortality (HR 1.12, 95% CI 1.02-1.23, P=0.016). Higher PROMIS PH and MH scores were associated with lower NRM (HR 0.49, 95% CI 0.26-0.94, P=0.031 and HR 0.28, 95% CI 0.14-0.56, P<0.001), respectively. DT scores had no associations with any outcome. Pts who developed acute GVHD had significantly higher PHQ-9 scores (mean 2.8 vs 1.9, P=0.014), PROMIS-PH (mean 45 vs 49, P=0.029) and MH scores (mean 47 vs 52, P=0.011) relative to those who did not have acute GVHD.PROs such as the PHQ-9, DT, and PROMIS have important clinical utility in allogeneic HCT recipients. Routine clinical use of these assessments not only help identify pts with high levels of distress or depression in real-time, they also demonstrate prognostic value for post-HCT survival outcomes. PROs are increasingly used in HCT to capture symptoms, quality of life, and functional status. At the Cleveland Clinic, PROs are systematically collected prior to ambulatory visits and used in routine clinical care to identify patients (pts) with distress in real-time through a data capture initiative called the "Knowledge Program." Instruments include the Patient Health Questionnaire (PHQ-9), National Comprehensive Cancer Network Distress Thermometer (DT), and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Health (PH) and Mental Health (MH) assessments. There are limited data on the use of these instruments in the HCT population. We evaluated these PRO measures in HCT recipients and their association with post-HCT outcomes. We identified 292 adult pts undergoing first allogeneic HCT from 2015-2018. Of those, 257 had at least one PRO assessment and were included in this analysis. Time intervals evaluated were: pre-HCT (within 3 months [mos]), 0-6 mos, 6-12 mos, 1-2 years (yrs), and 2-5 yrs post HCT. PHQ-9 assesses depression and categorized as minimal (score 0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). Higher DT scores indicate more distress and categorized as mild (0-3), moderate (4-7), severe (8-10). Lower scores on PROMIS indicate poorer PH or MH respectively. We evaluated PRO data descriptively for each time interval. Pre-HCT scores were analyzed for association with grade 2-4 acute graft-versus-host disease (GVHD), relapse, non-relapse mortality (NRM), and survival. Figure 1 shows boxplots for mean PHQ-9 and DT scores pre- and post-HCT. Mean scores for the PHQ-9 ranged from 1.1 ± 2.4 (SD) occurring >2 yrs post-HCT to 2.4 ± 3.0 pre-HCT. Mean DT scores were overall low, with highest distress (2.0 ± 2.2) seen pre-HCT. Mean scores for PH and MH were similar at each time intervals, with means ranging 47-48 for PH and 49-51 for MH. Higher PHQ-9 pre-HCT was associated with higher NRM (HR 1.21, 95% CI 1.09-1.34, P<0.001) and worse overall mortality (HR 1.12, 95% CI 1.02-1.23, P=0.016). Higher PROMIS PH and MH scores were associated with lower NRM (HR 0.49, 95% CI 0.26-0.94, P=0.031 and HR 0.28, 95% CI 0.14-0.56, P<0.001), respectively. DT scores had no associations with any outcome. Pts who developed acute GVHD had significantly higher PHQ-9 scores (mean 2.8 vs 1.9, P=0.014), PROMIS-PH (mean 45 vs 49, P=0.029) and MH scores (mean 47 vs 52, P=0.011) relative to those who did not have acute GVHD. PROs such as the PHQ-9, DT, and PROMIS have important clinical utility in allogeneic HCT recipients. Routine clinical use of these assessments not only help identify pts with high levels of distress or depression in real-time, they also demonstrate prognostic value for post-HCT survival outcomes. Figure 1.

Hematopoietic cell transplantation (HCT) is physically and psychologically challenging, potentially exposing patients to quality-of-life (QoL) impairments. Adolescent and young adults (AYAs, aged 15 to 39 years) are a vulnerable cohort facing multiple hurdles due to dynamic changes in several aspects of their lives. The AYA population may be particularly prone to QoL issues during HCT. We hypothesized that due to the unique psychosocial challenges faced by AYAs, they would have an inferior quality of life. We studied QoL differences between AYA (aged 15 to 39 years) and older adult (aged 40 to 60 years) allogeneic HCT recipients before and after HCT. Additionally, we determined if pre-HCT QoL for AYA transplant recipients changed over time. QoL data were collected prospectively before and after transplant on 431 recipients aged 15 to 60 years from June 2003 through December 2017 using the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) questionnaire. Repeated-measures analysis of variance was used to assess differences among age groups. Pearson correlation (r) was used to determine if baseline QoL had improved after HCT from June 2003 through December 2017 in the AYA cohort. QoL did not differ among younger AYAs, older AYAs, or older adults at any time in the first year after allogeneic HCT. At 1 year post-HCT, total FACT-BMT score and all FACT-BMT domains except physical well-being improved from pre-HCT in all age groups. From 2003 to 2017, AYA allogeneic recipients experienced modest improvement in additional concerns (r = 0.26, P = .003), trial outcome index (r = 0.23, P = .008), and total FACT-BMT score (r = 0.19, P = .031), although no improvements were seen in physical, social, emotional, or functional well-being. Contrary to our hypothesis, we found that QoL in the AYA population is similar to that of older adults before and after HCT. Improvements in QoL of AYA allogeneic patients since 2003 were driven by the additional concerns domain, which addresses multiple psychosocial aspects such as vocation, hobbies, and acceptance of illness. Continued efforts to tailor treatment and support for AYA HCT recipients is critical to improving QoL outcomes. (C) 2020 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.

Advance care planning (ACP) includes having conversations with loved ones and health care providers regarding health care wishes in various circumstances. It also includes completing advance directives such as a health care power of attorney and living will as well as preparing a will for finances and estate planning. This process helps patients make plans for their future health care goals and is particularly useful when they are unable to make their own medical decisions. ACP in hematopoietic stem-cell transplant (HSCT) recipients can be particularly challenging, given the treatment's significant morbidity and mortality yet curative potential. (Wang, W. S. et al, 2017). Recognizing this challenge, the Cleveland Clinic Blood and Marrow Transplant Program created a multi-disciplinary committee of social workers, physicians, advanced practice providers (APPs), nurse coordinators and nurses to address the gap in ACP for HSCT recipients to improve the overall quality of care provided to patients and families. As part of this initiative, we created a survey to assess perceptions of ACP within the program and comfort level.A confidential, fourteen question survey was created and administered to providers. The survey included questions on: 1) perceptions of the current approach to ACP in our program, 2)the comfort level of the provider in discussing goals of care, prognosis, and code status, 3) provider's current knowledge base and prior training. Open-ended feedback was also elicited.A total of 38 responded to the survey including 15 physicians, 7 APPs, 8 nurse coordinators, 3 social workers, and 3 inpatient nurses. The years of experience ranged from 0.5 to 21 plus years. The majority of providers felt our current approach to ACP was very good (n=11) or good (n=16). While the perception was overall favorable, less than half of the providers (n=14) felt we had adequate training to have goals of care discussions. Only 7 providers report having formal training in goals of care. Despite not having formal training, nearly all (n=37) thought it was important. The survey also assessed comfort level of initiating goals of care discussions, prognosis, and code status. The majority of providers reported feeling comfortable in all these areas: initiating goals of care n=25 (Figure 1), prognosis n=20 (Figure 2), and code status n=22 (Figure 3). Of the 21 who were comfortable initiating goals of care discussions 21 reported initiating these conversations in their clinical practice. Many providers (n= 37) also felt it was appropriate for all members of the team to initiate these discussions.ACP is an important part of HSCT multi-disciplinary care of patients and their families. This survey demonstrates our institution's perceptions of ACP, need for formal training to improve comfort levels, and highlights the need for ACP in HSCT to be approached by a multi-disciplinary team effort. Advance care planning (ACP) includes having conversations with loved ones and health care providers regarding health care wishes in various circumstances. It also includes completing advance directives such as a health care power of attorney and living will as well as preparing a will for finances and estate planning. This process helps patients make plans for their future health care goals and is particularly useful when they are unable to make their own medical decisions. ACP in hematopoietic stem-cell transplant (HSCT) recipients can be particularly challenging, given the treatment's significant morbidity and mortality yet curative potential. (Wang, W. S. et al, 2017). Recognizing this challenge, the Cleveland Clinic Blood and Marrow Transplant Program created a multi-disciplinary committee of social workers, physicians, advanced practice providers (APPs), nurse coordinators and nurses to address the gap in ACP for HSCT recipients to improve the overall quality of care provided to patients and families. As part of this initiative, we created a survey to assess perceptions of ACP within the program and comfort level. A confidential, fourteen question survey was created and administered to providers. The survey included questions on: 1) perceptions of the current approach to ACP in our program, 2)the comfort level of the provider in discussing goals of care, prognosis, and code status, 3) provider's current knowledge base and prior training. Open-ended feedback was also elicited. A total of 38 responded to the survey including 15 physicians, 7 APPs, 8 nurse coordinators, 3 social workers, and 3 inpatient nurses. The years of experience ranged from 0.5 to 21 plus years. The majority of providers felt our current approach to ACP was very good (n=11) or good (n=16). While the perception was overall favorable, less than half of the providers (n=14) felt we had adequate training to have goals of care discussions. Only 7 providers report having formal training in goals of care. Despite not having formal training, nearly all (n=37) thought it was important. The survey also assessed comfort level of initiating goals of care discussions, prognosis, and code status. The majority of providers reported feeling comfortable in all these areas: initiating goals of care n=25 (Figure 1), prognosis n=20 (Figure 2), and code status n=22 (Figure 3). Of the 21 who were comfortable initiating goals of care discussions 21 reported initiating these conversations in their clinical practice. Many providers (n= 37) also felt it was appropriate for all members of the team to initiate these discussions. ACP is an important part of HSCT multi-disciplinary care of patients and their families. This survey demonstrates our institution's perceptions of ACP, need for formal training to improve comfort levels, and highlights the need for ACP in HSCT to be approached by a multi-disciplinary team effort. Figures 1, 2 and 3.Figure 2I feel comfortable discussing prognosis with patients and/or their family.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Figure 3I feel comfortable discussing CODE status (ex. Full CODE, DNR/CCA, DNR).View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Advances in allogeneic hematopoietic cell transplantation (HCT) have led to significantly improved day 100 survival over time. Longer-term (≥1 year) survival, however, has not changed significantly. In an effort to improve outcomes and identify patients (pts) at higher risk for 1-year mortality, we created a day 100 risk assessment tool.The Day 100 Risk Assessment tool includes 11 items: HCT-co-morbidity index, distance from transplant center, performance status (PS) at day 100, GVHD requiring systemic corticosteroids, infection requiring intravenous antimicrobials, caregiver support, poor coping skills/motivation, substance abuse, poor health literacy/access, medication compliance, and “other” concerns from the care team. Pts were given a point for each identified factor and categorized as low risk (score 0-2) or high risk (score≥3). High risk pts were targeted for closer follow up beyond 100 days. Cox regression was used to identify risk factors for overall survival (OS) within the first year after HCT.Between 11/2015-6/2018, 208 pts underwent allogeneic HCT and 161 pts survived without relapse at day 100 (Table). Median follow up is 12 months (range 3-33). 1-year OS for low-risk pts was significantly better than for high-risk pts (82% vs 68%, P=0.006; Figure). Multivariable analysis accounting for both pre-transplant and Day 100 risk factors identified older age (≥55), (HR 2.92, 95% CI 1.21-7.08, P=0.017); high disease risk (HR 2.93, 95% CI 1.34-6.39, P=0.007), and day 100 high-risk score (HR 2.29, 95% CI 1.17-4.48, P=0.015) as significant factors for poor OS. Univariate analysis of individual components of the day 100 risk score identified poor PS at day 100, infection, and caregiving concerns as significant variables, P<0.004. A second multivariable model including individual factors demonstrated that poor PS (HR 2.68, P=0.013), infection (HR 2.57, P=0.009) and older age (HR 2.55, P=0.041) remained significantly associated with poor OS.In sum, we developed a Day 100 Risk Assessment tool and identified factors occurring within the first 100 days beyond traditional pre-transplant variables which significantly impact longer-term outcome. Targeted close follow up of these higher risk pts may help to improve survival of this at-risk population. Advances in allogeneic hematopoietic cell transplantation (HCT) have led to significantly improved day 100 survival over time. Longer-term (≥1 year) survival, however, has not changed significantly. In an effort to improve outcomes and identify patients (pts) at higher risk for 1-year mortality, we created a day 100 risk assessment tool. The Day 100 Risk Assessment tool includes 11 items: HCT-co-morbidity index, distance from transplant center, performance status (PS) at day 100, GVHD requiring systemic corticosteroids, infection requiring intravenous antimicrobials, caregiver support, poor coping skills/motivation, substance abuse, poor health literacy/access, medication compliance, and “other” concerns from the care team. Pts were given a point for each identified factor and categorized as low risk (score 0-2) or high risk (score≥3). High risk pts were targeted for closer follow up beyond 100 days. Cox regression was used to identify risk factors for overall survival (OS) within the first year after HCT. Between 11/2015-6/2018, 208 pts underwent allogeneic HCT and 161 pts survived without relapse at day 100 (Table). Median follow up is 12 months (range 3-33). 1-year OS for low-risk pts was significantly better than for high-risk pts (82% vs 68%, P=0.006; Figure). Multivariable analysis accounting for both pre-transplant and Day 100 risk factors identified older age (≥55), (HR 2.92, 95% CI 1.21-7.08, P=0.017); high disease risk (HR 2.93, 95% CI 1.34-6.39, P=0.007), and day 100 high-risk score (HR 2.29, 95% CI 1.17-4.48, P=0.015) as significant factors for poor OS. Univariate analysis of individual components of the day 100 risk score identified poor PS at day 100, infection, and caregiving concerns as significant variables, P<0.004. A second multivariable model including individual factors demonstrated that poor PS (HR 2.68, P=0.013), infection (HR 2.57, P=0.009) and older age (HR 2.55, P=0.041) remained significantly associated with poor OS. In sum, we developed a Day 100 Risk Assessment tool and identified factors occurring within the first 100 days beyond traditional pre-transplant variables which significantly impact longer-term outcome. Targeted close follow up of these higher risk pts may help to improve survival of this at-risk population. View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Psychosocial Assessment of Candidates for Transplant (PACT) is a tool originally developed to address psychosocial risks in solid organ transplant recipients and has the potential for application to hematopoietic cell transplantation (HCT) recipients. In a retrospective cohort study, we reviewed 404 adult allogeneic HCT cases from 2003 to 2014 to identify predictors of adverse psychosocial status as determined by PACT. Final PACT rating was poor/borderline (score 0–1) in 5%, acceptable (score 2) in 22%, good (score 3) in 44%, and excellent (score 4) in 29% recipients. In multivariable regression, higher PACT score was associated with White race (odds ratio [OR] 2.95, P < 0.001), having a related donor (OR 1.61, P = 0.015), and a higher quality of life score (OR 1.22/ 10-point increase in FACT-BMT total score, P < 0.001). PACT score correlated with all quality of life subscales. The final PACT score was associated with non-relapse mortality (HR 0.82/ 1-point increase, p = 0.03) in multivariable analysis that considered patient and disease factors, but not in models that also included transplant-related factors and performance status. PACT score was not associated with overall survival. PACT can be considered as part of a comprehensive psychosocial assessment for identifying patients who may require additional resources around allogeneic HCT.

The number of allogeneic hematopoietic cell transplantation (HCT) survivors is projected to increase and guidelines for screening and management of late effects have been established. Although the value of a systematic process for the long-term care of HCT survivors and screening of late effects is increasingly recognized, best practices for the implementation of survivorship care delivery has not been well described. In October 2016, we established a Survivorship Clinic for allogeneic HCT recipients in our Blood and Marrow Transplant (BMT) Program. A consultative model aimed to augment care provided by the patient's primary transplant and primary care physician was felt to best fit our program's needs. Patients (pts) are seen by a Nurse Practitioner (NP) and social worker (SW) at day 100 and 1 year visits. Visits include a comprehensive history and physical, symptom assessment, and graft-versus-host disease evaluation, as well as review and provision of a treatment summary and care plan. 1-year recommended assessments include: bone density scan, vitamin D, TSH, lipid panel, HbA1c, Ferritin, pulmonary function tests (PFTs), ophthalmic exam, and mammogram and pelvic exam (women). We performed a formal review of follow up with recommended screening guidelines among pts seen in our Survivorship Clinic from 2016-2018. Since its establishment, 161 pts received allogeneic HCT in our Program, of whom 131 pts have been seen at day 100 and 42 have been seen at 1-year. Patients not seen at day 100 were due to relapse, death or acute illness where they were not able to attend the clinic visit. Among pts seen at day 100 but not at 1 year, 7 were international, 2 were deferred due to relapse, 12 died prior to one year follow up, one transferred care to another facility and 67 have not reached their 1-year follow up. Of 42 pts seen at 1 year, all have received a complete treatment summary and care plan at both day 100 and 1 year. 35 pts had an evaluation and follow up with their transplant SW for psychosocial assessment. 41 pts had a bone density scan completed. All 42 pts completed a screening TSH, vitamin D, lipid panel, HbA1c, Ferritin, and PFTs. 36 saw ophthalmology for a yearly exam. Of the 20 women seen at 1 year, all 20 had mammograms done and 19 had gynecologic exams. In summary, this review of our NP run BMT survivorship clinic demonstrates feasibility and a high rate of adherence to recommended late effects screening practices for HCT survivors. As the survivorship program continues to grow, further integration of patient-reported outcomes and interventional research on late effects to improve the well-being of long-term survivors is planned.

A projected shortage of hematopoietic cell transplantation (HCT) health professionals was identified as a major issue during the National Marrow Donor Program/Be The Match System Capacity initiative. Work-related distress and work-life balance were noted to be potential barriers to recruitment/retention. This study examined these barriers and their association with career satisfaction across HCT disciplines. A cross-sectional, 90-item, web-based survey was administered to advanced practice providers, nurses, physicians, pharmacists, and social workers in 2015. Participants were recruited from membership lists of 6 professional groups. Burnout (measured with the Maslach Burnout Inventory subscales of emotional exhaustion and depersonalization) and moral distress (measured by Moral Distress Scale Revised) were examined to identify work-related distress. Additional questions addressed demographics, work-life balance, and career satisfaction. Of 5759 HCT providers who received an individualized invitation to participate, 914 (16%) responded; 627 additional participants responded to an open link survey. Significant differences in demographic and practice characteristics existed across disciplines (P<.05). The prevalence of burnout differed across disciplines (P<.05) with an overall prevalence of 40%. Over one-half of pharmacists had burnout, whereas social workers had the lowest prevalence at less than one-third. Moral distress scores ranged from 0 to 336 and varied by discipline (P<.05); pharmacists had the highest mean score (62.9 +/- 34.8) and social workers the lowest (42.7 +/- 24.4). In multivariate and univariate analyses, variables contributing to burnout varied by discipline; however, moral distress was a significant contributing factor for all providers. Those with burnout were more likely to report inadequate work-life balance and a low level of career satisfaction; however, overall there was a high level of career satisfaction across disciplines. Burnout, moral distress, and inadequate work-life balance existed at a variable rate in all HCT disciplines, yet career satisfaction was high. These results suggest specific areas to address in the work environment for HCT health professionals, especially the need for relief of moral distress and a greater degree of personal time. As the creation of healthy work environments is increasingly emphasized to improve quality care and decrease costs, these findings should be used by HCT leadership to develop interventions that mitigate work-related distress and in turn foster recruitment and retention of HCT providers. (C) 2017 American Society for Blood and Marrow Transplantation.

Clinical social workers are psychosocial care experts who provide interventions that aim to address the emotional, relational, financial, and logistical challenges that arise throughout the hematopoietic cell transplantation (HCT) treatment and recovery process. Interventions that contribute to better patient outcomes can include cognitive behavioral therapy and counseling for adaptation to illness, family planning for 24/7 caregiver availability and strategies to support patient activities of daily living, instruction on guided imagery and relaxation techniques for symptom management and to decrease anxiety, psychoeducation on the treatment trajectory, and linkage with financial resources. A Social Work Workforce Group (SWG) was established through the System Capacity Initiative, led by the National Marrow Donor Program/Be The Match, to characterize the current social work workforce capacity and challenges. The SWG conducted a web-based survey of Ha clinical social workers in the United States. The response rate was 57% (n = 90), representing 76 transplant centers. Survey results indicated that the clinical social worker role and scope of practice varies significantly between centers; less than half of respondents reported that their clinical social work expertise was used to its fullest potential. With an estimated 3-fold increase in HCT patient volume by 2020, the need for specialized psychosocial health services will increase. The SWG makes recommendations to build capacity for the psychosocial care of HO' patients and to more fully integrate the social worker as a core member of the HO' team. The SWG created a Blood and Marrow Transplant (BMT) Clinical Social Worker role description that can be used by transplant centers to educate healthcare professionals, benchmark utilization of clinical social workers, and improve comprehensive psychosocial health programs. (C) 2018 American Society for Blood and Marrow Transplantation.

Background: HCT is physically and psychologically challenging and patients are prone to QoL impairments. AYAs are a unique population that faces hurdles due to dynamic changes in several aspects of their life, and may be particularly prone to QoL issues during HCT. The aim of this study was to determine if QoL differences exist between AYA and older adult HCT recipients pre- and post-HCT. Additionally, we aimed to determine if there has been a change in QoL for AYA transplant recipients in recent years, as more focus has been placed on supporting this unique population. Methods: QoL data were collected prospectively pre-HCT (baseline [BL]) and in follow-up post-transplant on patients undergoing HCT from Jun 2003 through Dec 2017 at Cleveland Clinic. Autologous HCT recipients are followed routinely through day +42 post-transplant, while allogeneic recipients are followed through at least one year or more. QoL was self-reported by patients using the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) questionnaire. FACT-BMT consists of five domain scores (Physical Wellbeing [PWB], Social Wellbeing [SWB], Emotional Wellbeing [EWB], Functional Wellbeing [FWB], and Additional Concerns [AC]) and two summary scores (trial outcome index [TOI, PWB+FWB+AC], and Total FACT Score. Scores were compared for younger AYA (age 15-29 years), older AYA (age 30-39 years) and older adults (age 40-60 years). We excluded patients >60 years from analysis as this group may have their own unique challenges. Repeated measures analysis of variance was used to assess differences among age groups and among time points. Pearson correlation (r) was used to determine if BL QOL had improved from 2003-2017 in AYA cohort. Separate analyses were performed for autologous and allogeneic cohorts. Results: Autologous HCT cohort included 128 AYA patients (56 younger AYA) and 355 older adults, and allogeneic HCT cohort included 136 AYA patients (76 younger AYA) and 295 older adults Autologous patients in all three groups were similar for baseline characteristics except for diagnosis (table 1). Among allogeneic patients similar rates of graft-versus host disease were seen for all three groups, and baseline characteristics were similar except for ECOG performance status (table 1). Among autologous recipients, no single QoL domain or composite score differed among the three age groups at baseline or at day +42 post-HCT (Figure 1a). In all age groups, QoL improved from baseline to D+42 in autologous HCT recipients (mean Total Score 149 vs. 152, p=0.001). Similarly, among the allogeneic HCT recipients, no single QoL domain or composite score differed among the three age groups at baseline, day +100, +180, or +365 post-HCT (Figure 1b). Among all patients compared to BL (mean 146), total FACT score improved at day +180 (150, p=0.022) and +365 (152, p=0.005), but not at day 100 (145, p=0.57). Among autologous recipients, none of the BL FACT domains improved over time since 2003. In contrast, AYA allogeneic recipients also had no significant change in BL scores since 2003 for PWB, SWB, EWB, FWB, however there was improvement in AC (r=0.26, p=0.003, TOI (r=0.23, p=0.008), and total FACT score (r=0.19, p=0.03). Conclusions: AYA HCT recipients do not have inferior QoL compared to older adults in the first 42 days after autologous HCT and the first year after allogeneic HCT. Interestingly, QoL improvements in AYA patients have occurred in recent years for allogeneic but not autologous patients. Improvements in QoL of allogeneic patients is driven by the AC domain, which addresses multiple psychosocial aspects which have been emphasized in recent years. Continued efforts to tailor treatment and support for AYA HSCT recipients is critical to improving outcomes. Advani: Glycomimetics: Consultancy; Novartis: Consultancy; Amgen: Research Funding; Pfizer: Honoraria, Research Funding. Majhail:Atara: Honoraria; Anthem, Inc.: Consultancy; Incyte: Honoraria.

Abstract Background: Allo HCT candidates undergo comprehensive evaluations including psychosocial assessment, although there are no validated tools to objectively assess psychosocial status prior to transplant. PACT, originally developed to address psychosocial risks in solid organ transplant recipients, has been evaluated by our group in allo HCT patients (Foster et al, BMT, 2009). It consists of 8 subscales which are scored from 1 to 5 (support stability, support availability, psychopathology, risk for psychopathology, health lifestyle, drug and alcohol use, compliance, and relevant knowledge). A final PACT score (range 0-4) provides an overall impression of a patient's suitability for transplantation. Patients and Methods: This retrospective cohort study reviewed 404 adult allo HCT cases between 2003 and 2014 at Cleveland Clinic to identify predictors of adverse psychosocial status prior to allo HCT as determined by PACT. We then studied the association of PACT scores with allo HCT outcomes. Social workers generated a PACT score based on a comprehensive assessment of the patient. Median age of the study population was 50 (range 18-73) years, patients were 46% female, 11% non-White, 20% rural residents, and had mainly AML (41%) or MDS (18%). Majority of patients received HLA matched (84%) unrelated donor (55%) bone marrow grafts (55%) using myeloablative conditioning (78%). Results: Final PACT rating was poor/borderline (score 0/1) in 5% (n= 21), acceptable (score 2) in 22% (87), good (score 3) in 44% (177), and excellent (score 4) in 29% (119) of recipients. In multivariable ordinal logistic regression, higher PACT score at pre-HCT assessment was associated with White race (OR 2.95, [95% CI 1.56-5.58], p<0.001), having a related donor (OR 1.61, [1.10-2.37], p=0.015), and a higher total QoL score (OR 1.22 per 10-point increase, [1.12-1.32], p<0.001). Final PACT rating was not associated with other variables evaluated including gender, place of residence (urban/rural), household income, diagnosis, disease risk, or time since diagnosis. Lower PACT score (0/1) was associated with poorer OS (57% versus 67% for PACT score 4), however this was not significant (P=0.11). A significant trend in 1-year non-relapse mortality (NRM) was observed (ranged from 33% to 16%, respectively, P=0.03); however, this association with NRM was not seen in multivariable analysis (HR 0.88, P=0.17). Patients with higher PACT ratings tended to spend more days outside the hospital alive in the first hundred days post-HCT in both univariate (P=0.07) and multivariable (P=0.09) analyses. We also analyzed individual PACT subscales with outcomes. None of the eight PACT subscales were associated with 1-year OS. However, "support availability" and "relevant knowledge" were associated with 1-year NRM in univariate analysis, although, only "relevant knowledge" remained significant on multivariable analysis (HR 0.81 per 1-point increase, [0.69-0.96], p=0.012) after adjusting for patient, disease, and transplant characteristics. Conclusion: Non-White race, lack of a related donor, and lower QOL are associated with adverse psychosocial risk as measured by PACT prior to allo HCT. Low "relevant knowledge" and "final PACT" ratings were associated with NRM and suggest vulnerable populations. PACT can be effectively used as part of a comprehensive psychosocial assessment for identifying patients who may require additional psychological and social resources to help them navigate the transplant process. Disclosures Lee: Kadmon: Research Funding; Onyx: Research Funding; Amgen: Consultancy, Research Funding; Mallinckrodt: Honoraria; Pfizer: Consultancy; Takeda: Research Funding; Incyte: Consultancy. Majhail:Atara: Honoraria; Anthem, Inc.: Consultancy; Incyte: Honoraria.

High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is frequently performed in patients with hematologic malignancies. ASCT can result in significant nausea, pain, and discomfort. Supportive care has improved, and pharmacologic therapies are frequently used, but with limitations. Music has been demonstrated to improve nausea and pain in patients undergoing chemotherapy, but little data are available regarding the effects of music therapy in the transplantation setting. In a prospective study, patients with lymphoma or multiple myeloma undergoing ASCT were randomized to receive either interactive music therapy with a board-certified music therapist or no music therapy. The music therapy arm received 2 music therapy sessions on days +1 and +5. Primary outcomes were perception of pain and nausea measured on a visual analog scale. Secondary outcomes were narcotic pain medication use from day -1 to day +5 and impact of ASCT on patient mood as assessed by Profile of Mood States (POMS) on day +5. Eighty-two patients were enrolled, with 37 in the music therapy arm and 45 in the no music therapy arm. Patients who received MT had slightly increased nausea by day +7 compared with the no music therapy patients. The music therapy and no music therapy patients had similar pain scores; however, the patients who received music therapy used significantly less narcotic pain medication (median, 24 mg versus 73 mg; P = .038). Music therapy may be a viable nonpharmacologic method of pain management for patients undergoing ASCT; the music therapy patients required significantly fewer morphine equivalent doses compared with the no music therapy patients. Additional research is needed to better understand the effects of music therapy on patient-perceived symptoms, such as pain and nausea.

The projected shortage of hematopoietic cell transplantation (HCT) health professionals was identified as a major issue during the National Marrow Donor Program's System Capacity Initiative. In response, a multi-disciplinary working group formed to address recruitment/retention issues for HCT providers. Care of HCT recipients can be physically and emotionally challenging, and the need to address work-related distress and work-life balance was identified. This study examines these barriers as well as their association with career satisfaction across HCT disciplines. A cross-sectional, 90-item, web-based survey was administered to advanced practice providers (APP), nurses, physicians, pharmacists, and social workers in 2015. Participants were recruited from membership lists of 6 professional groups (Figure 1). The dimensions of burnout (as measured by Maslach Burnout Inventory [MBI] subscales of emotional exhaustion [EE] and depersonalization [DP]) and moral distress (as measured by Moral Distress Scale – Revised) were examined to identify work-related distress. Additional questions addressed work-life balance, career satisfaction, and demographics. Of 5,759 HCT providers who received individualized invites to participate, 914 responded (16%); additional participants responded to an open link survey (Figure 1). Significant differences in demographic and practice characteristics were found across discipline (P < 0.05). Physicians reported the highest percentage of working > 60 hours per week. APPs, physicians, and pharmacists had higher percentages of burnout (Table 1). Moral distress varied by discipline (P < 0.05); pharmacists had the highest mean score (62.9±34.8) and social workers the lowest (42.7±24.4). Among the groups, only 31% physicians agreed they had enough time for personal/family life (Figure 2), yet 81% were satisfied with their career in HCT (Figure 3). Although limited by size and response rate, study results suggest specific areas to address in the work environment for HCT health professionals by discipline, especially the need for personal time and relief of emotional exhaustion. As the creation of healthy work environments is increasingly emphasized in healthcare to improve quality care and decrease costs, these findings can be used by HCT leadership to develop interventions which mitigate work-related distress, and in turn foster recruitment and retention of HCT providers.Figure 2Reponses to statement, "My work schedule leaves me enough time for personal/family life," by disciplineView Large Image Figure ViewerDownload Hi-res image Download (PPT)Reponses to statement, "I am satisfied with my career in HCT," by discilineView Large Image Figure ViewerDownload Hi-res image Download (PPT)Table 1MBI-EE/DP Scores measuring bumout by disciplineMBI Sub scaleAPPn=255(%)Nursen=763(%)Physiciann=330(%)Pharmacistn=95(%)Social Workern=98 (%)EE ScoreLow (0-16)2032351626Medium (17-26)3635323546High (27-54)4433334929DP ScoreLow (0-8)8379737491Medium (9-13)111418188High (14-30)671081BurnoutNo5562594770Yes4538415330Note: ≥ 27 on EE score and/or ≥ 10 on DP score is defined as burnout. Open table in a new tab

Patients under consideration for allogeneic hematopoietic cell transplantation (HCT) undergo comprehensive evaluation, including psychosocial assessment, to evaluate their candidacy for transplant. Psychosocial factors such as presence of availability of a consistent care-partner, mental health needs, psychological issues such as depression and severe anxiety, and compliance can impact risks of toxicity and adverse outcomes including survival. However, instruments to objectively characterize psychosocial status in this population are generally lacking. Our group has previously assessed the Psychosocial Assessment of Candidates for Transplant (PACT) scale, originally developed for solid organ transplant recipients, to screen for psychosocial risk factors in allogeneic HCT patients (Foster et al, BMT, 2009). The PACT captures information in four domains (social support, psychological health, lifestyle factors, and patients understanding of the transplant process). The overall impression of the patient's suitability for transplantation is assigned a final PACT score ranging from 0 (poor candidate) to 4 (excellent candidate). We conducted a retrospective cohort study of 404 adult allogeneic HCT recipients (median age 50 [range, 18-73] years) between 2003 and 2014 at our institution to evaluate the association of PACT scale with other baseline clinical and sociodemographic factors and quality of life (QOL) prior to HCT, and its association with HCT outcomes. Patients were predominantly male (54%), White (89%), had acute leukemia/MDS (77%), had unrelated donor (55%), and received myeloablative regimens (78%). Based on ZIP code of residence, median annual household income for our cohort was $49,159 and 80% resided in Rural Urban Commuting Area designated urban area. Final PACT rating was poor/borderline (0-1) in 21 (5%), acceptable (2) in 87 (22%), good (3) in 177 (44%), and excellent (4) in 119 (29%) recipients. Significantly higher PACT ratings were observed in patients who were White (P=0.004), had higher household income (p=0.019), higher Karnofsky performance score (P=0.011), and low risk HCT-Comorbidity Index score (P=0.007). Final PACT rating was weakly correlated with the pre-HCT FACT BMT total QOL score (R=0.22), including its subdomains. A trend towards more days alive and outside the hospital in the first 100 days post-HCT was seen in patients with higher final PACT score (median 58, 65, 66, and 70 days for scores 0-1, 2, 3, and 4) in both univariable (P=0.07) and multivariable (P=0.09) analysis. At 1-year after HCT, cumulative incidence of non-relapse mortality for patients with PACT score 0-1 was 33%, for score 2 was 24%, for score 3 was 27% and score 4 was 16%. The 1-year overall survival probability for the four groups was 57%, 60%, 59% and 67%, respectively. In multivariable analysis that adjusted for patient and disease characteristics (including race/ethnicity, household income, place of residence and pre-HCT QOL), final PACT rating was associated with non-relapse mortality (HR 0.82 per point increase [95% CI, 0.69-0.98], P=0.03), but not with overall survival (HR 0.91 [95% CI, 0.79-1.05], P=0.18). There was no association between final PACT rating and neutrophil or platelet engraftment, acute or chronic graft-versus-host disease, or relapse. In conclusion the PACT scale provides prognostic information for NRM independent of clinical and other sociodemographic factors as an indicator of psychosocial adjustment post-HCT. The PACT scale can serve as a useful tool for screening adult patients for psychosocial risk factors prior to allogeneic HCT and may identify patients who need additional social support and resources to minimize risks of mortality after transplantation.

Quality of life (QOL) is an important outcome for hematopoietic cell transplantation (HCT) recipients. Whether pre-HCT QOL adds prognostic information to patient and disease related risk factors has not been well described. We investigated the association of pre-HCT QOL with relapse, non-relapse mortality (NRM), and overall mortality after allogeneic HCT. From 2003 to 2012, the Functional Assessment of Cancer Therapy-Bone Marrow Transplant Scale instrument was administered before transplantation to 409 first allogeneic HCT recipients. We examined the association of the three outcomes with (1) individual QOL domains, (2) trial outcome index (TOI) and (3) total score. In multivariable models with individual domains, functional well-being (hazard ratio (HR) 0.95, P=0.025) and additional concerns (HR 1.39, P=0.002) were associated with reduced risk of relapse, no domain was associated with NRM, and better physical well-being was associated with reduced risk of overall mortality (HR 0.97, P=0.04). TOI was not associated with relapse or NRM but was associated with reduced risk of overall mortality (HR 0.93, P=0.05). Total score was not associated with any of the three outcomes. HCT-comorbidity index score was prognostic for greater risk of relapse and mortality but not NRM. QOL assessments, particularly physical functioning and functional well-being, may provide independent prognostic information beyond standard clinical measures in allogeneic HCT recipients.