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

NCT05047926 | Completed

• 2 other identifiers: 21-005226NCI-2021-09494
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  Weekly up to 4 months

Secondary Outcomes (9)

• Implementation outcome

  Up to 4 months

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

  Baseline

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

  Up to 4 months

• 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

Study Arms (3)

Cohort 1 (surveys, CT, blood samples)

EXPERIMENTAL

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

Other: Survey Administration; Procedure: Computed Tomography; Procedure: Biospecimen Collection

Cohort 2 (exercise, supplement, Resilient Living)

EXPERIMENTAL

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.

Dietary Supplement: Nutritional Supplement Drink; Other: Physical Activity; Other: Survey Administration; Procedure: Computed Tomography; Behavioral: Health Education

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

EXPERIMENTAL

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.

Behavioral: Behavioral Counseling; Dietary Supplement: Nutritional Supplement Drink; Other: Physical Activity; Other: Survey Administration; Behavioral: Health Education; Other: Medical Device Usage and Evaluation

Interventions

Behavioral Counseling BEHAVIORAL

Undergo behavioral counseling

Also known as: Behavior Counseling, Behavioral Psychotherapy

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

Nutritional Supplement Drink DIETARY_SUPPLEMENT

Given Boost or Ensure

Also known as: Boost, Ensure, Polymeric Enteral Nutrition Formula

Cohort 2 (exercise, supplement, Resilient Living); Cohort 3 (exercise, supplement, coaching, Resilient Living)

Physical Activity OTHER

Complete physical activity assignments

Cohort 2 (exercise, supplement, Resilient Living); Cohort 3 (exercise, supplement, coaching, Resilient Living)

Survey Administration OTHER

Complete surveys

Cohort 1 (surveys, CT, blood samples); Cohort 2 (exercise, supplement, Resilient Living); Cohort 3 (exercise, supplement, coaching, Resilient Living)

Computed Tomography PROCEDURE

Undergo CT scans

Also known as: CAT, CAT Scan, Computed Axial Tomography (CAT), computerized axial tomography, Computerized axial tomography (procedure), Computerized Tomography (CT) scan, Computerized Tomography, CT, CT Scan, tomography

Cohort 1 (surveys, CT, blood samples); Cohort 2 (exercise, supplement, Resilient Living)

Biospecimen Collection PROCEDURE

Undergo blood collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cohort 1 (surveys, CT, blood samples)

Health Education BEHAVIORAL

Complete Resilient Living program

Cohort 2 (exercise, supplement, Resilient Living); Cohort 3 (exercise, supplement, coaching, Resilient Living)

Medical Device Usage and Evaluation OTHER

Wear a FitBit

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hemiplegia or paraplegia
• Current pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Behavior Therapy; Exercise; Specimen Handling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Amanika A. Kumar, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: October 5, 2021
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)