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 — OTHER
    Receive written prehabilitation education materials
  • Goal Setting — OTHER
    Follow and meet prehabilitation goals
  • Interview — OTHER
    Ancillary studies
  • Referral — OTHER
    Receive tailored multidisciplinary referrals
  • Rehabilitation — PROCEDURE
    Attend cancer physiatry consultation
  • Supportive Care — OTHER
    Receive resistance bands, nutritional guidance sources, and tips and resources
  • Survey Administration — OTHER
    Ancillary studies
  • Tailored Intervention — PROCEDURE
    Receive 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)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Jessica Cheng
626-218-4673
City of Hope at Irvine LennarIrvineCalifornia92618
Jessica Cheng
949-759-2863
Jessica Cheng (PRINCIPAL_INVESTIGATOR)

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