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

PRIMARY OBJECTIVES:

I. Determine feasibility based on adherence (\> 70%) across the key components-exercise (aerobic and resistance), nutrition, and mind/spirit practice-in \> 70% of enrolled patients for the 28-day period immediately prior to surgery.

II. Evaluate feasibility via enrollment rate \> 50% of eligible patients.

SECONDARY OBJECTIVES:

I. Evaluate physical measures: Six Minute Walk Test, Duke Activity Status Index, 30-second Sit to Stand, Short Physical Performance Battery, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief Three Domains (3D) Profile, and body composition.

II. Assess exercise behavior measures: Godin-Shephard Leisure-Time Physical Activity Questionnaire, self-reported exercise activity and future intent, Self-Efficacy for Home Exercise Programs.

III. Evaluate malnutrition risk with Malnutrition Screening Tool. IV. Assess psychological and spiritual distress with relevant measures within the Edmonton Symptom Assessment Scale- Financial and Spiritual Distress (ESAS-FS) and European Quality of Life 5 Dimensions (EQ-5D-5L).

V. Evaluate symptom burden with ESAS-FS and health-related quality of life with EQ-5D-5L.

EXPLORATORY OBJECTIVES:

I. Evaluate the impact of the tailored prehabilitation program on disease outcomes as measured by Relative Dose Intensity, pathologic complete response, Response Evaluation Criteria in Solid Tumors, and cancer antigen 125 (CA-125).

II. Evaluate the impact of the tailored prehabilitation program on cancer treatment timing by examining time from diagnosis to surgery, time from last chemotherapy cycle to surgery, time from surgery to adjuvant treatment, hospitalizations and length of stay.

III. Evaluate the impact of the tailored prehabilitation program on cancer treatment complications, measured by the incidence of chemotherapy-induced peripheral neuropathy (using Common Terminology Criteria for Adverse Events \[CTCAE\] 5.0) and 30-day readmission rate.

IV. Identify future program improvements via a participant feedback survey and/or interview, clinician feedback survey and/or interview, reasons for non-participation, challenges to intervention adherence, and days to consult completion.

V. Document the utilization of multidisciplinary specialty services.

OUTLINE:

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.

• Enrollment rate (Feasibility) [Срок оценки: Up to 1 year]
• Change in physical measures - Six Minute Walk Test (6MWT) [Срок оценки: From Baseline up to 21-35 days post-surgery]
• Change in physical measures - Duke Activity Status Index (DASI) [Срок оценки: From Baseline up to 21-35 days post-surgery]
• Change in physical measures - 30-second Sit to Stand (30STS) [Срок оценки: From Baseline up to 21-35 days post-surgery]
• Change in physical measures - Short Physical Performance Battery (SPPB) [Срок оценки: From Baseline up to 21-35 days post-surgery]
• Change in physical measures - Reported Outcomes Measurement Information System (PROMS) Cancer Function Brief 3D Profile [Срок оценки: From Baseline up to 21-35 days post-surgery]
• Change in physical measures - Body composition [Срок оценки: From Baseline up to 21-35 days post-surgery]
• Change in exercise behavior measures - Godin-Shephard Leisure-Time Physical Activity Questionnaire [Срок оценки: From Baseline to 21-35 days post-surgery]
• Change in exercise behavior measures - Self-reported exercise activity [Срок оценки: From Baseline to 21-35 days post-surgery]
• Change in exercise behavior measures - Self-Efficacy for Home Exercise Programs (SEHEPS) [Срок оценки: From Baseline to 21-35 days post-surgery]
• Change in malnutrition risk [Срок оценки: Baseline to 21-35 days post-surgery]
• Change in psychological and spiritual distress [Срок оценки: Baseline to 21-35 days post-surgery]