Assessing patient and carer experiences in end-of-life care for gynecological cancer
Palliation in Gynae-oncology: Patients Expectations and Assessment of Care
This study is trying to understand how patients with advanced gynecological cancer and their caregivers feel about the care they receive at the end of life to improve future support and services.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Nordic Society of Gynaecological Oncology - Clinical Trials Unit Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05142150 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility and acceptability of collecting data on patients' and carers' perceptions of care in the context of end-of-life (EOL) for individuals with advanced gynecological cancers. It focuses on understanding patient satisfaction, the importance of various aspects of care, and the experiences of carers during bereavement. The study will involve a cohort of patients who will complete questionnaires regarding their care experiences, and ideally, each patient will nominate a carer to participate as well. The data collected will help inform patient-centered EOL care practices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with advanced gynecological malignancies and a life expectancy of approximately four months.
Not a fit: Patients who are not experiencing advanced gynecological cancers or those with a life expectancy significantly longer than four months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of end-of-life care for patients with gynecological cancers by aligning care with patient and carer preferences.
How similar studies have performed: While there is limited data on EOL care specifically for gynecological cancers, similar studies in other cancer types have shown success in improving patient and carer satisfaction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A patient will be eligible for inclusion only if all of the following criteria are fulfilled: 1. Patients with any advanced gynecological malignancy and a life expectancy of approximately 4 months as estimated by their treating physician\*. Potential patient groups include, but are not limited to, those with platinum-resistant/refractory recurrent epithelial ovarian cancer (PRR-EOC), metastatic/recurrent cervical or endometrial cancer progressing after platinum-based chemotherapy; high grade/undifferentiated metastatic uterine sarcoma progressing after first-line chemotherapy etc. 2. Patients may be on active cancer treatment, about to commence active cancer treatment or under observation/palliative care. 3. Age ≥ 18 years 4. Able (both physically and cognitively) to complete patient-reported outcome measures independently in languages that are available in this study (i.e. without assistance from hospital translator). Exclusion Criteria: A patient will not be eligible for inclusion if any of the following criteria are fulfilled: 1. Unable to be comply with the protocol. 2. A medical or psychological condition that limits the patient´s capacity to give informed consent, such as cognitive impairment, delirium, psychosis etc. 3. Participation in another clinical trial. A patient will be asked to appoint a carer. Inclusion criteria carer: 1. Age ≥ 18 years 2. A relative or close friend who is actively supporting the patient in her illness 3. Able (both physically and cognitively) to complete questionnaires independently in languages that are available in this study (i.e. without assistance from hospital translator). Exclusion criteria carer A carer will not be eligible for inclusion if any of the following criteria are fulfilled: 1. Unable to be comply with the protocol 2. A medical or psychological condition that limits the carer´s capacity to give informed consent, such as cognitive impairment, delirium, psychosis etc.
Where this trial is running
Oslo
- The Norwegian Radium Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Kristina Lindemann, MD, PhD
- Email: klinde@ous-hf.no
- Phone: 004722934983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.