NCT05047926

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

Prehabilitation for Advanced Ovarian Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
BEHAVIORAL	Behavioral Counseling	Undergo behavioral counseling
DIETARY_SUPPLEMENT	Nutritional Supplement Drink	Given Boost or Ensure
OTHER	Physical Activity	Complete physical activity assignments
OTHER	Survey Administration	Complete surveys
PROCEDURE	Computed Tomography	Undergo CT scans
PROCEDURE	Biospecimen Collection	Undergo blood collection
BEHAVIORAL	Health Education	Complete Resilient Living program
OTHER	Medical Device Usage and Evaluation	Wear a FitBit

Timeline

• Start date: 2021-10-05
• Primary completion: 2025-07-08
• Completion: 2025-07-08
• First posted: 2021-09-17
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States