Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Surgery for Advanced Gynecological Cancer: A Pilot Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 2
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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