MedTrace Logo

Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer

NCT05092763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-29

No results posted yet for this study

Summary

The purpose of this study is to test the effectiveness of a home-based, patient-tailored intervention, FIT4SURGERY, to promote physical activity among women with ovarian cancer undergoing neoadjuvant chemotherapy.

Conditions

Interventions

BEHAVIORAL

FIT4SURGERY

The Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls. Patients are asked to wear the Fitbit through the entire 9-12 weeks in which they are receiving neoadjuvant chemotherapy both when asleep and when awake. Patients are taught how to understand the Fitbit outputs on the application, for example, understanding how to monitor their steps and heart rate. Caregivers are also be encouraged to assist patients. Patients are provided with information about the benefits of physical activity and effective behavior change strategies for incorporating physical activity into their daily lives. These include things such as short bouts of activity by walking around the room during commercial breaks or planning to be dropped off a short walk from a destination.

BEHAVIORAL

Healthy Lifestyle Control

Participants assigned to this study arm are instructed to go about their usual activities and receive education about physical activity and a healthy lifestyle for ovarian cancer patients. They are encouraged to download the free Cancer.Net mobile app and visit the cancer.net website for educational materials related to ovarian cancer and survivorship. At the end of the 9-12 week intervention, participants in the Healthy Lifestyle group receive a Fitbit for their optional, personal use after surgery.

Sponsors & Collaborators

Principal Investigators

  • Emma Barber, MD, MS · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092763 on ClinicalTrials.gov