Physiatry-Led Cancer Prehabilitation During Neoadjuvant Systemic Therapy to Improve Function in Stage III-IVA Gynecologic Cancer Patients

NCT07608445 | Not Yet Recruiting DMC

• 3 other identifiers: 24765P30CA033572NCI-2026-03209
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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

Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Participant completion and adherence to the prescribed training program (Feasibility)

  Feasibility will be determined primarily by participant adherence to the prescribed training program during the 28-day period immediately prior to surgery, with the goal of \> 70% adherence across each key category-exercise (aerobic and resistance), nutrition, and mind/spirit practice-in \> 70% of enrolled patients. Adherence will be measured via a self-reported weekly training log that will be turned in routinely to the clinical research staff. Feasibility assessment will include descriptive statistics such as frequencies (%), along with estimates of precision (95% confidence intervals).

  Up to 28 days immediately prior to surgery

Secondary Outcomes (14)

• Enrollment rate (Feasibility)

  Up to 1 year

• Change in physical measures - Six Minute Walk Test (6MWT)

  From Baseline up to 21-35 days post-surgery

• Change in physical measures - Duke Activity Status Index (DASI)

  From Baseline up to 21-35 days post-surgery

• Change in physical measures - 30-second Sit to Stand (30STS)

  From Baseline up to 21-35 days post-surgery

• Change in physical measures - Short Physical Performance Battery (SPPB)

  From Baseline up to 21-35 days post-surgery

Study Arms (1)

Supportive care (physiatry-led prehabilitation)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Goal Setting; Other: Interview; Other: Referral; Procedure: Rehabilitation; Other: Supportive Care; Other: Survey Administration; Procedure: Tailored Intervention

Interventions

Educational Intervention OTHER

Receive written prehabilitation education materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (physiatry-led prehabilitation)

Goal Setting OTHER

Follow and meet prehabilitation goals

Supportive care (physiatry-led prehabilitation)

Interview OTHER

Ancillary studies

Supportive care (physiatry-led prehabilitation)

Referral OTHER

Receive tailored multidisciplinary referrals

Also known as: Referred

Supportive care (physiatry-led prehabilitation)

Rehabilitation PROCEDURE

Attend cancer physiatry consultation

Also known as: Physical Health Services / Rehabilitation, rehabilitation therapy, Rehabilitation, Medical

Supportive care (physiatry-led prehabilitation)

Supportive Care OTHER

Receive resistance bands, nutritional guidance sources, and tips and resources

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Supportive care (physiatry-led prehabilitation)

Survey Administration OTHER

Ancillary studies

Supportive care (physiatry-led prehabilitation)

Tailored Intervention PROCEDURE

Receive starter prescription

Supportive care (physiatry-led prehabilitation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods; Organizational Objectives; Interviews as Topic; Referral and Consultation; Rehabilitation; Palliative Care

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Organization and Administration; Health Services Administration; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Professional Practice; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Jessica Cheng

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): November 13, 2026
• Primary Completion (Estimated): November 26, 2027
• Study Completion (Estimated): November 26, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

US (2)