Physiatry-Led Cancer Prehabilitation During Neoadjuvant Systemic Therapy to Improve Function in Stage III-IVA Gynecologic Cancer Patients
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT07608445
- Status
- Not Yet Recruiting
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Conditions
- Malignant Female Reproductive System Neoplasm
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Educational Intervention — OTHERReceive written prehabilitation education materials
- Goal Setting — OTHERFollow and meet prehabilitation goals
- Interview — OTHERAncillary studies
- Referral — OTHERReceive tailored multidisciplinary referrals
- Rehabilitation — PROCEDUREAttend cancer physiatry consultation
- Supportive Care — OTHERReceive resistance bands, nutritional guidance sources, and tips and resources
- Survey Administration — OTHERAncillary studies
- Tailored Intervention — PROCEDUREReceive starter prescription
Study Details
This clinical trial studies whether physiatry-led cancer prehabilitation can be used during systemic treatment before surgery (neoadjuvant systemic treatment \[NST\]) to improve function in stage III-IVA gynecologic cancer patients. Treatment of gynecologic cancers presents significant challenges to physical and mental health and patients often experience many challenges following treatment including sleep disturbance, extreme tiredness, sexual dysfunction, and bowel and urinary problems. Patients who have low functioning prior to surgery often have worse outcomes following surgery; however, services to support functional shortages often start after surgery. Physiatry-led cancer prehabilitation is a strategy aimed at reducing post-treatment functional challenges by improving physical and mental function before treatment. It involves physiatry, which is a medical specialty focused on function. Physiatry involvement in prehabilitation allows for the evaluation and management of co-existing conditions, medical supervision, and the coordination of complex plans involving multiple teams. Using physiatry-led cancer prehabilitation during NST may be an effective way to improve function in stage III-IVA gynecologic cancer patients.
Key Dates
- Start date
- Nov 13, 2026
- Status verified
- May 2026
- Primary completion
- Nov 26, 2027
- Completion
- Nov 26, 2027
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Supportive care (physiatry-led prehabilitation)Patients attend a cancer physiatry consultation over 1 hour and receive an introduction to the home-based program, a starter prescription, and written prehabilitation education materials before the start of cycle 2 of NST. Patients then follow the provided starter prescription and attempt to meet aerobic exercise, resistance exercise, nutrition, and psychospiritual goals at home during and while off NST in the absence of unacceptable toxicity. Patients also attend additional cancer physiatry consultation follow-ups at 28 days and at 28 days after surgery. Additionally, patients receive resistance bands, sources for nutritional guidance, and practical tips and resources on study and may also receive tailored multidisciplinary referrals as needed.
Primary Outcome Measure
Participant completion and adherence to the prescribed training program (Feasibility) [ Time Frame: Up to 28 days immediately prior to surgery ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | Jessica Cheng (PRINCIPAL_INVESTIGATOR) |
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