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

Not Applicable

Recruiting

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

• Registration Number: NCT05047926
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-17
• Study Start: 2021-10-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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Exclusion Criteria

• Hemiplegia or paraplegia
• Current pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3 (exercise, supplement, coaching, Resilient Living)	Physical Activity	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.
Cohort 3 (exercise, supplement, coaching, Resilient Living)	Survey Administration	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.
Cohort 2 (exercise, supplement, Resilient Living)	Nutritional Supplement Drink	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 2 (exercise, supplement, Resilient Living)	Health Education	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 (exercise, supplement, coaching, Resilient Living)	Nutritional Supplement Drink	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.
Cohort 1 (surveys, CT, blood samples)	Biospecimen Collection	Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
Cohort 2 (exercise, supplement, Resilient Living)	Computed Tomography	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 (exercise, supplement, coaching, Resilient Living)	Medical Device Usage and Evaluation	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.
Cohort 1 (surveys, CT, blood samples)	Survey Administration	Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
Cohort 1 (surveys, CT, blood samples)	Computed Tomography	Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.
Cohort 2 (exercise, supplement, Resilient Living)	Physical Activity	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 2 (exercise, supplement, Resilient Living)	Survey Administration	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 (exercise, supplement, coaching, Resilient Living)	Health Education	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.
Cohort 3 (exercise, supplement, coaching, Resilient Living)	Behavioral Counseling	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.

Primary Outcome Measures

Name	Time	Method
Adherence to each prehabilitation component based on patient reported adherence (Cohorts 2 & 3)	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

Secondary Outcome Measures

Name	Time	Method
Implementation outcome	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.
Difference in Short Physical Performance Battery (SPPB) at baseline between cohorts 1 and 2	Baseline	Short Physical Performance Battery (SPPB) will be measured at baseline in both cohorts.
Correlation of body composition on computed tomography (CT) scans to frailty assessments	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.
Acceptability of remote setting in Cohort 3	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.
Correlation of Short Physical Performance Battery (SPPB) to other assessments in cohorts 1 and 2	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.
Correlation of assessments to compliance with interventions in cohort 2	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.
Correlation of frailty assessments with clinical judgement of frailty	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.
Change of Short Physical Performance Battery (SPPB) over time in cohort 2	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).
Qualitative outcomes of the facilitators, barriers, perceived benefits, and burdens	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States