Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

Mayo Clinic90 enrolled

Overview

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.

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. OUTLINE: Patients are assigned to 1 of 3 cohorts. COHORT 1: Patients undergoing primary surgical intervention complete surveys, undergo computed tomography (CT), and undergo collection of blood samples at baseline. COHORT 2: Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial. COHORT 3: Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Interventions

Behavioral CounselingBEHAVIORAL

Undergo behavioral counseling

Nutritional Supplement DrinkDIETARY_SUPPLEMENT

Given Boost or Ensure

Physical ActivityOTHER

Complete physical activity assignments

Survey AdministrationOTHER

Complete surveys

Computed TomographyPROCEDURE

Undergo CT scans

Biospecimen CollectionPROCEDURE

Undergo blood collection

Health EducationBEHAVIORAL

Complete Resilient Living program

Medical Device Usage and EvaluationOTHER

Wear a FitBit

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Time frame: Weekly up to 4 months

Secondary Outcomes

Implementation outcome

Ability to recruit to this type of study and perform assessments at our institution will be measured based on the number of patients enrolled and the number of assessments completed throughout the study.

Time frame: Up to 4 months

Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2

Short Physical Performance Battery (SPPB) will be measured at baseline in both cohorts.

Time frame: Baseline

Change of Short Physical Performance Battery (SPPB) over time in cohort 2

The Short Physical Performance Battery (SPPB) assessment will be administered and scored at baseline and at each study visit to assess lower extremity functioning (balance, gait, standing up from a chair).

Time frame: Up to 4 months

Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2

The following assessment tools will be completed at baseline, after chemotherapy/prior to surgery (cohort 2), 6 weeks post surgery (cohort 2), and after completion of all primary anti-cancer treatment (cohort 2): Short Physical Performance Battery (SPPB); gait speed (measured in meters/second); patient reported outcomes through Patient-Reported Outcomes Measurement Information System (PROMIS) short form surveys in the domains of pain, physical function, anxiety, emotional support, and fatigue; perceived stress scale; Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale.