Severe chronic insomnia is a common sleep disorder that is mostly persistent and needs to be treated. Pharmacologic treatment options and guidelines are sparse, particularly for long-term treatment. Our study aimed to investigate a graduated therapy scheme for moderate-to-severe chronic insomnia in practice, considering the effects on self-reported sleep quality and quality of life. Patients with moderate-to-severe chronic insomnia were given appropriate medication according to a graduated therapy scheme, ranging from l-tryptophan (as the first choice, least potent) to Z-drugs and combination therapies (as the last option, most potent). Each step of the graduated therapy scheme was tested for at least 4 weeks. Data related to sleep and quality of life were collected in questionnaire form (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Beck Depression Inventory, second edition, and Short Form 36 Health Survey) at baseline and during the course of the treatment after 1, 3, 6, 9, and 12 months. Of 86 eligible patients, 60.5 https://drks.de/search/de/trial/DRKS00033175 ; Identifier: DRKS00033175. Boer J, Toncar T, Stange A, Rosenblum L, Fietze I. Effect of graduated drug therapy for moderate-to-severe chronic insomnia on the severity of disease: an observational study in Germany. J Clin Sleep Med. 2025;21(1):33–45.

Objective: Clinical trials require the inclusion of all relevant demographic groups, including under-represented populations, to ensure accurate and representative findings. The aim of the study was to assess the status quo of inclusion, diversity, equity, and access in clinical trials across various countries. Methods: An 18-item online survey was developed and administered to 5 people. The questionnaire was distributed to delegates from gynecologic research groups in the Gynecologic Cancer Intergroup Network worldwide. All the analyses are purely descriptive. Results: A total of 73 participants (86.3% physicians and 47.9% female) from 33 countries participated in the survey; 91.8% deemed the inclusion of under-represented groups in clinical trials important, and 91.2% supported increasing representation in phase III trials. Most participants believed that language barriers (68.7%) and restricted eligibility criteria (56.7%) were the main reasons for under-representation. Language barriers are seen as more significant in Africa and Europe than in Asia (83.3% and 75.0% vs 58.6%, respectively). Limited patient knowledge about clinical trials (73.1%) was also cited as a key issue. Only 20.5% reported having a minimal data set to document demographic groups. The most helpful measure was the provision of trial information in various languages (69.7%). Overall, women were more supportive of all the suggested improvement measures than were men. Conclusions: There is a need for better strategies to improve diversity in clinical trials, focusing on overcoming language barriers and eligibility constraints.

Findings from clinical trials have led to advancement of care for patients with gynecologic malignancies. However, restrictive inclusion of patients into trials has been widely criticized for inadequate representation of the real-world population. Ideally, patients enrolled in clinical trials should represent a broader population to enhance external validity and facilitate translation of outcomes across all relevant groups. Specifically, there has been a systematic lack of data for underrepresented groups, with many studies failing to report or differentiate study participants based on sociodemographic domains, such as race and ethnicity. As such, the impact of treatment in these underrepresented groups is poorly understood, and clinical outcomes according to various sociodemographic factors are infrequently assessed. Inclusion of diverse trial participants, with different racial and ethnic background, is essential for the understanding of factors that may impact clinical outcomes. Therefore, we conducted a multi-national meeting of clinical trial groups and industry with the goal of increasing equity, diversity, and inclusion in gynecologic cancer clinical trials and to address barriers to recruitment, participation, and harmonization of data collection and reporting. These Gynecologic Cancer Intergroup (GCIG) statements present recommendations and strategies for the gynecologic cancer research community to improve equity, diversity, and inclusion in gynecologic cancer clinical trials.

Introduction/Background Aim of the study is to establish a survivorship clinic for long-term survivors (LTS) with gynaecological cancer as a new form of care to improve quality of life. This preliminary analysis aims to evaluate their health status to gain further insight into LTS' needs. Methodology Non-randomized, controlled, multi-center, open intervention study with two parallel groups (n=180 per group). The intervention group takes part in the holistic survivorship clinic at Charité – Universitätsmedizin Berlin; the control group (recruited by the North-East German Society for Gynecological Oncology) receives routine follow-up care. Main inclusion criterion: gynaecological cancer at least five years ago. Primary endpoint is health-specific quality of life (SF-36) after 12 months; secondary endpoints include frequency and severity of long-term side effects. Results A total of 373 LTS could be recruited: ovarian (n=249; 67%), cervical (n=83; 22%), endometrial cancer (n=41; 11%). Last patient-out will be 06/2024. Main comorbidities were hypertension (35%), arthrosis (33%) and hypothyroidism (24%). Comedications were documented in 80% of cases. Prior to recruitment, one-third of patients (35%) had been hospitalized within the preceding year, and 24% visited the emergency department. LTS had a median number of 12 physician contacts within one year (range: 1–160 consultations). Most frequent long-term side effects in the intervention group (n=192) were lymphedema (53%), vaginal dryness (50%), gastrointestinal symptoms (45%), psycho-oncological need (43%), memory problems (43%), polyneuropathy (42%) and sleeping disorders (42%). Altogether, 90 received optional specialized survivorship care from neurology (recommendations: n=147), 86 from mental health (recommendations: n=153), 52 from the fatigue centre (recommendations: n=108), and 43 from sexual medicine. Conclusion LTS still experience a wide range of (tumor-/therapy-related) symptoms. Specialized survivorship care may help to coordinate health care for LTS with the aim of promoting physical and mental health in order to improve quality of life. Disclosures Kommoss S: Receipt of grants/research supports: GSK Receipt of honoraria or consultation fees: GSK, Eisai, Astra Zeneca, MSD Liebrich C: Receipt of honoraria or consultation fees: Roche, Tesaro, GSK, MSK, NCO - New Concept Oncology Schmalfeldt B: Receipt of grants/research supports: Astra Zeneca, DaiichiSankyo, Roche, GSK, MSD, Eisai, MedConcept Receipt of honoraria or consultation fees: Astra Zeneca, DaiichiSankyo, Roche, GSK, MSD, Eisai, MedConcept Wimberger P: Receipt of grants/research supports: Amgen, GSK, Clovis, AstraZeneca, MSD, Novartis, Pfizer, Lilly, Roche, Pierre Fabre Receipt of honoraria or consultation fees: AstraZeneca, MSD, Eisai, Novartis, Roche, Amgen, Clovis, Pfizer, Gilliad, Lilly Sehouli J: Receipt of grants/research supports: AstraZeneca, Clovis Oncology, Merck, Bayer, PharmaMar, Pfizer, Tesaro, MSD Oncology, Roche Receipt of honoraria or consultation fees: AstraZeneca, Clovis Oncology, PharmaMar, Merck, Pfizer, Tesaro, MSD Oncology, Lilly, Novocure, J&J, Roche, Ingress Health, Riemser, Sobi, GSK, Novartis, Eisai, Olympus Medical Systems, Pfizer, Teva, Bayer

Introduction: Although creative therapies like painting, dancing, and writing are often used and encouraged to treat various diseases, including cancer, there are few systematic scientific studies on innovative therapies in medical care. Methods: An anonymous survey was developed for female patients, their relatives, and female medical staff on the impact of creative therapies on optimizing clinical therapy management in exclusively female trials. Results: Of 718 respondents, 358 were female patients, 69 were medical personnel, and 291 were in the control group. Overall, 91.2% of respondents had sought access to creative therapies, indicating strong self-motivated engagement in activities to improve health and well-being. This study also uncovered a significant preference for creative writing among patients. Furthermore, the data suggest that integrating innovative therapies into biopsychosocial anamnesis could offer valuable insights into patients’ mobility, mood, and social behaviors. Despite a general hesitation to discuss leisure activities with medical professionals, many patients wanted to incorporate creative activities into their treatment plans. Moreover, group settings for innovative therapy were preferred, highlighting the need for more structured support in medical environments to facilitate these therapeutic interactions. Conclusions: This study suggests creative therapies can be valuable in medical care.

There is a distinct preponderance of female insomniacs when compared to male insomniacs. The aim of this study was to examine possible gender differences in the causes for insomnia, and the phenotypes of insomnia, and to investigate whether gender-specific insomnia diagnosis and treatment could be relevant in clinical practice. Data were collected from 121 insomniac patients by a medical specialist in the framework of normal clinical practice in Germany. The data consist of the patient’s medical history and various sleep-related patient questionnaires. Data from both genders were tested for independence using chi-square tests and Mann–Whitney U tests. We found a correlation between the gender of the patient and insomnia phenotypes in several aspects: concomitant lipometabolic disorders, diabetes mellitus, and high BMIs are more common in male insomniacs (p < 0.05). Frequency of insomnia occurrence in certain age groups, insomnia severity, distribution of SOI (sleep onset insomnia), SMI (sleep maintenance insomnia) and combined SOI + SMI, sleep duration, the time needed to seek medical consultation, trying out sleep-inducing drugs/techniques and the trigger, etiology and familial predisposition of the insomniac disorder were independent of the patient’s gender. We would like to re-evaluate the results with a larger number of patients in a further study.

e24120 Background: In recent years, the understanding of endometrial cancer shifted, leading to a change in therapy strategies including targeted therapies. For a successful conduction of therapy, a patient’s expectations, preferences, and needs should be considered. The aim of this study was to define these factors. Methods: We conducted an international 80 item survey in paper-form and via the internet for endometrial cancer patients. The data recorded were demographics, tumor stage, therapy, recurrence status, comorbidities, preferences and expectations concerning therapy modalities. Results: Between 12/2021 and 12/2022, 568 endometrial cancer patients could be recruited from seven different countries – with the majority being from Germany (54.3%) and Switzerland (44.0%). Median age was 66.0 [58.0; 73.0] years. While most patients (79.7%) were in follow-up care with no current anti-cancer therapy, 20.3% were still receiving treatment, of which 6.2% were due to cancer recurrence. In total, 14.6% of all patients suffered a relapse. More than two thirds were concomitantly suffering from high blood pressure (39.6%) and/or joint pain (arthrosis, arthritis) (30.5%) – a fifth (21.3%) did not have any pre-existing illnesses. On average, the patients took 2.9 (±3.0) different drugs regularly for their comorbidities. The distribution of initial tumor status was 62.5% for FIGO I, and 16.6%, 15.1% and 5.8% for FIGO II-IV, respectively. A third of the patients (34.7%) reported that their tumor was tested for molecular classification, more than half (56.9%) did not know if this had occurred. After first being diagnosed, most patients (96.6%) underwent an operation, 39.5% received radiation therapy, 27.6% chemotherapy, 7.1% hormonal treatment and 3.6% immunotherapy. More than a third (38.1%) of all patients would be interested in participating in clinical studies, less than half (43.6%) were offered this option. To receive information about their disease, 36.8% use the internet, but most (91.5%) think that the doctors’ expertise is the most important source of information. More than half (55.0%) see a need for more information material. To improve treatment, patients would like doctors to spend more time on explanations (31.2%), to better cooperate with each other (21.0%) and for the therapy not to lead to hair loss (20.6%). The maximum time of therapy, that most patients are willing to tolerate if everything goes well is 6-12 months (41.3%) followed by the time period until recurrence (34.4%). Conclusions: Women with endometrial cancer would benefit from significant improvement in the management of endometrial cancer, including the provision of information and educational materials and access to clinical trials. Clinical trial information: DRKS00025954 .

Introduction/Background Endometrial cancer (EC) is commonly associated with cardiovascular risk factors such as obesity and metabolic diseases. Especially in type 1 cancer, strong correlation with these characteristics was demonstrated. For successful holistic conduction of therapy, the patient's wish for change and compliance must be understood better. The aim of this study was to define the status quo of patient needs and preferences. Methodology An 80 item survey in paper-form and via internet was distributed to patients with diagnosed EC in seven countries. General patient characteristics (comorbidities, tumor stage, therapy), monitoring of lifestyle before and after diagnosis and adherence to treatment modalities were recorded. Results Between 12/2021 and 04/2023, 656 patients with EC (median age: 65.0[20.0; 92.0] years) completed the survey. Major recruitment took place in Germany (56%) and Switzerland (41%). The most common comorbidities were hypertension (42%), diabetes (13%) and hypothyroidism (20%). 46% of patients reported not exercising before diagnosis of EC. Only 14% increased their activity after diagnosis, 39% did even less (49% of those due to weakness). The need for medical exercise programs was low – only 30% were interested - although 55% felt that more activity would benefit their disease. 62% reported that they had not changed their diet after diagnosis. 31% would be interested in a professional nutrition counseling program, 81% did not receive one during treatment. Regarding screening programs, 52% participated in the colonoscopy program, 61% in the cervical cancer program, 34% in the skin cancer program and 71% in mammography screening. Conclusion A majority of patients believe in a potential positive impact of lifestyle changes, such as exercising and diets. Nevertheless, physical activity appeared to be relatively low and most patients did not change their diet after diagnosis. There is a need for better support of patients in these aspects, to achieve the known benefits of holistic treatment. Disclosures Financial support by GlaxoSmithKline Research & Development Limited.

BACKGROUND:Delivering bad news to patients is one of the most challenging tasks in medical practice. Despite its great relevance to patients, relatives, and medical staff, there is a paucity of data pertaining to training, experience, expectations, and preferences of physicians and medical students on breaking bad news. METHODS:We conducted an international survey in Germany, Switzerland, and Austria using an online questionnaire among physicians and medical students. RESULTS:A total of 786 physicians and 303 medical students completed the survey. Physicians stated that 32.7% deliver bad news several times a week and 45.2% several times a month. Difficulties controlling their emotions (35.1%) and remaining professional (43.4%) were the greatest challenges for physicians. Delivering bad news is associated with feelings of anxiety, both among experienced physicians (median of 3.8 out of 10.0) and medical students (median of 5.3). Conveying bad news is a burden to physicians and consequently has a substantial impact on their job satisfaction. All participants reported the need for more communication training concerning this subject. Only 49.5% of medical students and 67.3% of physicians mentioned having learned adequate communication skills. Our data demonstrate that communication training decreases the level of anxiety and increases the feeling of self-confidence towards breaking bad news. Preferred educational tools were seminars with simulation (students: 71.4%, physicians: 49.5%), observing more senior faculty (students: 57.4%, physicians: 55.1%), and supervision and feedback sessions (students: 36.3%, physicians: 45.7%). The largest barriers regarding education on communication were limited time (students: 77.0%, physicians: 74.9%) and missing awareness of supervisors (students: 60.6%, physicians: 41.1%). CONCLUSIONS:Our study showed a great need for systematic training and education in breaking bad news among physicians and medical students. Hospitals, medical schools, and postgraduate training programs are strongly encouraged to fill this gap, and improve sustainable doctor-patient communication to overcome the psychological burden for physicians.

Introduction/Background Nausea and vomiting are one of the most common and challenging side effects related to chemotherapy. The aim of the study was to develop a predictive score for chemotherapy-induced nausea and vomiting (CINV) in patients with gynaecological cancers planned for chemotherapy by identifying non-pharmacological, patient-related risk factors. Methodology A research-based questionnaire of 27 risk factors was designed and handed out to chemotherapy-naïve patients with gynaecological malignancies. Data on nausea and vomiting from at least 3 cycles of therapy was collected. Variable selection via stepwise and LASSO regression combined with patients' history was used to determine few questions with high predictive power. Bayesian logistic regression (risk prediction model) was implemented with a cut-off chosen to reach a sensitivity of 80%. Area under the curve analysis (AUC) was performed and the accuracy of prediction calculated. Results 191 patients were enrolled, of which 174 (91.1%) received at least one dose of chemotherapy (intention-to-treat population). Most patients suffered from ovarian cancer (68.0%) and received the carboplatinum/paclitaxel chemotherapy combination (57.5%). Leading predictive factors for CINV were educational status, nausea and vomiting due to other medication, motion sickness, anxiety from therapy in general, anxiety from nausea due to therapy, emetogenic potential of the therapy and distress level. 142 (81.6%) patients answered all questions concerning these factors. Among those, 107 (66.0%) were affected by nausea or vomiting. The AUC of the predictive score based on the above mentioned factors was 0.727 (95% CI [0.636, 0.818]), with a sensitivity of 80.4% [72.9%, 87.9%], a specificity of 48.6% [31.4%, 65.7%] and an overall accuracy of 72.5% [65.5%, 79.6%]. Conclusion To this day, a patient-related predictive model for the occurrence of CINV is missing, making the choice of the right antiemetic prophylaxis difficult. The score featured in our study showed very promising predictive power and is currently being validated.