Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
NCT ID: NCT05047926
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2021-10-05
2025-07-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Cohort 1 (surveys, CT, blood samples)
Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
Survey Administration
Complete surveys
Computed Tomography
Undergo CT scans
Biospecimen Collection
Undergo blood collection
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.
Nutritional Supplement Drink
Given Boost or Ensure
Physical Activity
Complete physical activity assignments
Survey Administration
Complete surveys
Computed Tomography
Undergo CT scans
Health Education
Complete Resilient Living program
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.
Behavioral Counseling
Undergo behavioral counseling
Nutritional Supplement Drink
Given Boost or Ensure
Physical Activity
Complete physical activity assignments
Survey Administration
Complete surveys
Health Education
Complete Resilient Living program
Medical Device Usage and Evaluation
Wear a FitBit
Interventions
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Behavioral Counseling
Undergo behavioral counseling
Nutritional Supplement Drink
Given Boost or Ensure
Physical Activity
Complete physical activity assignments
Survey Administration
Complete surveys
Computed Tomography
Undergo CT scans
Biospecimen Collection
Undergo blood collection
Health Education
Complete Resilient Living program
Medical Device Usage and Evaluation
Wear a FitBit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Current pregnancy
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Amanika A. Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-09494
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-005226
Identifier Type: -
Identifier Source: org_study_id
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