Screening and assessment for older patients with ovarian cancer
FRAGINOC Study: The Impact of FRAilty Screening and Geriatric Assessment and Intervention in Older Patients With Epithelial Ovarian Cancer
This study is testing whether a special assessment and personalized exercise program can help older patients with ovarian cancer get better treatment options compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 70 Years to 120 Years |
| Sex | Female |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Odense, Region of South Denmark and 4 other locations) |
| Trial ID | NCT05810701 on ClinicalTrials.gov |
What this trial studies
This study focuses on older patients diagnosed with epithelial ovarian cancer, aiming to improve treatment outcomes through a comprehensive geriatric assessment (CGA) and individualized physical training. The research will compare the effectiveness of this approach against standard care, particularly in increasing the number of patients eligible for interval debulking surgery. Additionally, it will evaluate the performance of various validated screening tests to identify frailty and immunodeficiency in these patients. The study seeks to address the gap in treatment for frail older patients who are often undertreated or over-treated due to their age and health status.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults newly diagnosed with ovarian cancer who can understand written and oral Danish.
Not a fit: Patients with other active cancers in the past five years or severe psychiatric diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better treatment outcomes and reduced complications for older patients with ovarian cancer.
How similar studies have performed: Other studies have indicated the potential benefits of geriatric assessments in oncology, but this specific approach for ovarian cancer in older patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed ovarian cancer * Capable of understanding written and oral danish Exclusion Criteria: * Other active cancers in the preceding 5 years * Severe psychiatric disease Patients referred to primary debulking surgery will be followed in a observational design
Where this trial is running
Odense, Region of South Denmark and 4 other locations
- Odense University Hospital — Odense, Region of South Denmark, Denmark (Recruiting)
- Vejle Hospital — Vejle, Region of South Denmark, Denmark (Recruiting)
- Zealand University Hospital — Roskilde, Region Sjælland, Denmark (Recruiting)
- Copenhagen University Hospital Rigshospitalet — Copenhagen, The Capital Region of Denmark, Denmark (Recruiting)
- Herlev and Gentofte Hospital — Herlev, The Capital Region of Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Tine Henrichsen Schnack, PhD
- Email: tine.henrichsen.schnack@rsyd.dk
- Phone: +4527284828
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.