Clinical trial NCT05047926: Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
Official title: Prehabilitation for Advanced Ovarian Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Ovarian Carcinoma
Stage IIIC Fallopian Tube Cancer AJCC V8
Stage IIIC Ovarian Cancer AJCC V8
Stage IIIC Primary Peritoneal Cancer AJCC V8
Stage IV Fallopian Tube Cancer AJCC V8
Stage IV Ovarian Cancer AJCC V8
Stage IV Primary Peritoneal Cancer AJCC V8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)
timeFrame: Weekly up to 4 months
Secondary outcomes:
measure: Implementation outcome
timeFrame: Up to 4 months
measure: Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2
timeFrame: Baseline
measure: Change of Short Physical Performance Battery (SPPB) over time in cohort 2
timeFrame: Up to 4 months
measure: Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2
timeFrame: Baseline, up to 4 months
measure: Correlation of assessments to compliance with interventions in cohort 2
timeFrame: Baseline, up to 4 months
measure: Correlation of frailty assessments with clinical judgement of frailty
timeFrame: Baseline, up to 4 months
measure: Correlation of body composition on computed tomography (CT) scans to frailty assessments
timeFrame: Baseline, up to 4 months
measure: Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens
timeFrame: Baseline, up to 4 months
measure: Acceptability of remote setting in Cohort 3
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Amanika A. Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: