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.
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: 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
Single group
Educational Intervention
Other interventionReceive written prehabilitation education materials
Goal Setting
Other interventionFollow and meet prehabilitation goals
Interview
Other interventionAncillary studies
Referral
Other interventionReceive tailored multidisciplinary referrals
Rehabilitation
Procedure/SurgeryAttend cancer physiatry consultation
Supportive Care
Other interventionReceive resistance bands, nutritional guidance sources, and tips and resources
Survey Administration
Other interventionAncillary studies
Tailored Intervention
Procedure/SurgeryReceive starter prescription
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).
Enrollment rate (Feasibility)
Secondarily, feasibility will be evaluated via enrollment rate \> 50% of eligible patients. Feasibility assessment will include descriptive statistics such as frequencies (%), along with estimates of precision (95% confidence intervals).
Change in physical measures - Six Minute Walk Test (6MWT)
This Six Minute Walk Test (6MWT) test measures the distance a patient walks in 6 minutes. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis.
Change in physical measures - Duke Activity Status Index (DASI)
This is a 12-question validated patient-reported outcome measure of self-reported functional capacity. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis.
Change in physical measures - 30-second Sit to Stand (30STS)
This is an objective measure of functional capacity and lower body functional strength assessing how many times a person can go from sitting to standing within 30 seconds. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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