Prehabilitation for Advanced Ovarian Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)
Study Overview
Brief Summary
This clinical trial evaluates whether a prehabilitation program started at the time of neoadjuvant chemotherapy will affect surgical recovery in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. A prehabilitation program may improve the quality of life after surgery for patients with ovarian, fallopian tube, or primary peritoneal cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the baseline difference in objective frailty measurements in patients with advanced ovarian cancer clinically deemed acceptable for primary surgery versus neoadjuvant chemotherapy.
II. To evaluate level of adherence and retention of patients with advanced ovarian cancer undergoing neoadjuvant chemotherapy with a prehabilitation program.
EXPLORATORY OBJECTIVE:
I. Will examine longitudinal trends and variability in function by the Short Physical Performance Battery (SPPB) over time and in response to the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >= 18 years old
- •Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis
- •Suspected Stage IIIC or IV disease based on clinician staging and imaging
- •Curative intent treatment with platinum-based chemotherapy
- •Planned surgical intervention at some point during treatment course
- •Ability to read English
- •No diagnosed severe cognitive impairment
- •Ability to provide consent
- •Ability to utilize technology to watch online modules for the Resilient Living Program
Exclusion Criteria
- •Hemiplegia or paraplegia
- •Current pregnancy
Outcomes
Primary Outcomes
Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)
Time Frame: Weekly up to 4 months
Assessed based on patient reported adherence in Cohort 2. For cohort 3, adherence will be documented in MyDataHelps® and monitored remotely by the study team on the Care Evolution platform®. Participants will be evaluated weekly for compliance with the recommended exercise and nutrition and resilience interventions. Documentation of adherence will be through online patient messages, phone call, or during in person visits, whichever the patient prefers
Secondary Outcomes
- Implementation outcome(Up to 4 months)
- Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2(Baseline)
- Correlation of body composition on computed tomography (CT) scans to frailty assessments(Baseline, up to 4 months)
- Acceptability of remote setting in Cohort 3(30 days)
- Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2(Baseline, up to 4 months)
- Correlation of assessments to compliance with interventions in cohort 2(Baseline, up to 4 months)
- Correlation of frailty assessments with clinical judgement of frailty(Baseline, up to 4 months)
- Change of Short Physical Performance Battery (SPPB) over time in cohort 2(Up to 4 months)
- Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens(Baseline, up to 4 months)