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

March 7, 2024 updated by: Amanika Kumar, M.D., Mayo Clinic

Prehabilitation for Advanced Ovarian Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Amanika A. Kumar, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 (surveys, CT, blood samples)
Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
Other: Survey Administration
Complete surveys
Procedure: Biospecimen Collection
Undergo blood collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Computed Tomography
Undergo CT scans
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Tomography
  • CT Scan
  • tomography
  • computerized axial tomography
  • Computerized axial tomography (procedure)
  • Computed Axial Tomography (CAT)
  • Computerized Tomography (CT) scan
Experimental: Cohort 2 (exercise, supplement, Resilient Living)
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.
Other: Survey Administration
Complete surveys
Procedure: Computed Tomography
Undergo CT scans
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Tomography
  • CT Scan
  • tomography
  • computerized axial tomography
  • Computerized axial tomography (procedure)
  • Computed Axial Tomography (CAT)
  • Computerized Tomography (CT) scan
Dietary supplement: Nutritional Supplement Drink
Given Boost or Ensure
Other Names:
  • Ensure
  • Boost
  • Polymeric Enteral Nutrition Formula
Other: Physical Activity
Complete physical activity assignments
Behavioral: Health Education
Complete Resilient Living program
Experimental: Cohort 3 (exercise, supplement, coaching, Resilient Living)
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.
Other: Survey Administration
Complete surveys
Behavioral: Behavioral Counseling
Undergo behavioral counseling
Other Names:
  • Behavior Counseling
  • Behavioral Psychotherapy
Dietary supplement: Nutritional Supplement Drink
Given Boost or Ensure
Other Names:
  • Ensure
  • Boost
  • Polymeric Enteral Nutrition Formula
Other: Physical Activity
Complete physical activity assignments
Behavioral: Health Education
Complete Resilient Living program
Other: Medical Device Usage and Evaluation
Wear a FitBit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weekly up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation outcome
Time Frame: Up to 4 months
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.
Up to 4 months
Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2
Time Frame: Baseline
Short Physical Performance Battery (SPPB) will be measured at baseline in both cohorts.
Baseline
Change of Short Physical Performance Battery (SPPB) over time in cohort 2
Time Frame: Up to 4 months
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).
Up to 4 months
Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2
Time Frame: Baseline, up to 4 months
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.
Baseline, up to 4 months
Correlation of assessments to compliance with interventions in cohort 2
Time Frame: Baseline, up to 4 months
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.
Baseline, up to 4 months
Correlation of frailty assessments with clinical judgement of frailty
Time Frame: Baseline, up to 4 months
The following assessments 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): Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale. Results from these will be compared for correlation.
Baseline, up to 4 months
Correlation of body composition on computed tomography (CT) scans to frailty assessments
Time Frame: Baseline, up to 4 months
The following assessments 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): Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale. Results from these will be compared for correlation.
Baseline, up to 4 months
Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens
Time Frame: Baseline, up to 4 months
Qualitative data from weekly contacts and exit interviews will be analyzed for codes and organized in themes to elucidate barriers, facilitators, perceived benefits, and negative effects of the program.
Baseline, up to 4 months
Acceptability of remote setting in Cohort 3
Time Frame: 30 days
Assessed using an Acceptability Questionnaire, which consists of 6 questions answered on a scale of 1-10 where 1=not at all and 10=extremely.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Amanika A. Kumar, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-005226
  • NCI-2021-09494 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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