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

Mayo Clinic

Status: Completed

Conditions: Advanced Ovarian Carcinoma; Stage IIIC Ovarian Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8; Stage IIIC Fallopian Tube Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Fallopian Tube Cancer AJCC v8; Stage IIIC Primary Peritoneal Cancer AJCC v8

Treatments: Dietary Supplement: Nutritional Supplement Drink; Behavioral: Behavioral Counseling; Other: Survey Administration; Procedure: Computed Tomography; Other: Physical Activity; Other: Medical Device Usage and Evaluation; Procedure: Biospecimen Collection; Behavioral: Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05047926

21-005226

NCI-2021-09494 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Cohort 1 (surveys, CT, blood samples)

Experimental group

Description:

Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.

Treatment:

Procedure: Biospecimen Collection

Procedure: Computed Tomography

Other: Survey Administration

Cohort 2 (exercise, supplement, Resilient Living)

Experimental group

Description:

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.

Treatment:

Behavioral: Health Education

Other: Physical Activity

Procedure: Computed Tomography

Other: Survey Administration

Dietary Supplement: Nutritional Supplement Drink

Cohort 3 (exercise, supplement, coaching, Resilient Living)

Experimental group

Description:

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.

Treatment:

Behavioral: Health Education

Other: Medical Device Usage and Evaluation

Other: Physical Activity

Other: Survey Administration

Dietary Supplement: Nutritional Supplement Drink

Behavioral: Behavioral Counseling