Clinical trial · Interventional
Physiatry-Led Cancer Prehabilitation During Neoadjuvant Systemic Therapy to Improve Function in Stage III-IVA Gynecologic Cancer Patients
Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Surgery for Advanced Gynecological Cancer: A Pilot Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Intervention | Other | — | UNRESOLVED |
| Goal Setting | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Referral | Other | — | UNRESOLVED |
| Rehabilitation | Procedure | — | UNRESOLVED |
| Supportive Care | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Tailored Intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (physiatry-led prehabilitation)
- description
- 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.
- interventionNames
- Other: Educational Intervention
- Other: Goal Setting
- Other: Interview
- Other: Referral
- Procedure: Rehabilitation
- Other: Supportive Care
- Other: Survey Administration
- Procedure: Tailored Intervention
Primary outcomes (1)
- measure
- Participant completion and adherence to the prescribed training program (Feasibility)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PATIENT: Documented informed consent of the participant * PATIENT: Willingness to comply with a physiatry consultation, start a tailored training program, and follow-up assessments * PATIENT: Age: ≥ 18 years * PATIENT: Able to read and write in English * PATIENT: A diagnosis of stage III-IVA gynecologic cancer planned for NST * PATIENT: Plan to start NST at City of Hope Orange County * HEALTHCARE TEAM: Documented informed consent of the participant * HEALTHCARE TEAM: Willingness to complete the Healthcare Worker Survey * HEALTHCARE TEAM: ≥ 18 years old * HEALTHCARE TEAM: Physicians, advanced practice providers, nurses, medical assistants, rehabilitation therapists, social workers, dietitians, mental health professionals, and other clinical staff who interact with study participants in the course of routine care Exclusion Criteria: * PATIENT: Current or planned cancer treatment for a second cancer * PATIENT: Clinically significant uncontrolled illness limiting participation with the research intervention and assessments * PATIENT: Stage IVB cancer with distant metastases * PATIENT: Other active malignancy * PATIENT: Pregnant or breastfeeding * PATIENT: Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * PATIENT: Meeting or exceeding exercise guidelines over the last one month based on the responses from the Godin-Shephard Leisure Time Physical Activity Questionnaire (GSLTPAQ) * PATIENT: Started second cycle before the physiatry consult * PATIENT: Inability to independently follow instructions for study assessments for any reason such as mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with the prehabilitation interventions or with the data collection process.) * PATIENT: Unable to independently answer questionnaires in English * HEALTHCARE TEAM: Healthcare workers who do not interact with study participants and therefore cannot provide relevant feedback
References
Publications (0)
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