Physical activity program for older women with gynecologic cancers
Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy (Fit4Treatment)
NA · Northwestern University · NCT05743517
This study is testing a physical activity program designed for older women with gynecologic cancers to see if it helps them feel better and stay active during treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | Northwestern University (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05743517 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a physical activity intervention tailored for older women diagnosed with gynecologic cancers, such as ovarian and cervical cancer. Participants will engage in a core program that includes a wearable activity tracker and a commercially available app, with additional components like a symptom-burden tailored app, exercise partner, oncology provider engagement, and coaching. The goal is to enhance physical activity levels, improve quality of life, and potentially increase cancer-specific survival among patients undergoing systemic therapies. The study addresses the unique challenges faced by older women in maintaining physical activity during cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are women over 60 years old who have been diagnosed with endometrial, ovarian, cervical, or vulvar/vaginal cancer and are undergoing systemic treatment.
Not a fit: Patients with uncontrolled cardiovascular disease, active brain metastases, or significant cognitive or functional limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and survival rates for older women undergoing treatment for gynecologic cancers.
How similar studies have performed: Previous studies have shown that physical activity interventions can reduce functional decline and improve outcomes in cancer survivors, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female; \> 60 years of age * Diagnosis of endometrial/uterine, ovarian, cervical or vulvar/vaginal cancer * Undergoing or planning to undergo any systemic treatment for a gynecologic malignancy (e.g., chemotherapy, immunotherapy, anti-angiogenic therapies, targeted therapies, etc.) * Willing to try to identify an exercise partner to participate with them, if needed * Fluent in English Exclusion Criteria: * Uncontrolled cardiovascular disease or other major contraindications to physical activity * Active brain metastases * Cognitive or functional limitations that preclude a patient's ability to participate in the physical activity intervention * Pregnant women or prisoners
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Emma Barber, MD, MS — Northwestern University
- Study coordinator: Anne Grace, PhD
- Email: anne@northwestern.edu
- Phone: 312-503-4165
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.
Conditions: Ovary Cancer, Endometrial Cancer, Uterine Cancer, Cervical Cancer, Cervix Cancer, Vulvar Cancer, Vaginal Cancer, behavioral intervention