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

NCT05092763 | Completed

• 1 other identifier: STU00215518
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Ovarian Cancer; Neoadjuvant Chemotherapy; Prehabilitation

Keywords

ovarian cancer; neoadjuvant chemotherapy; chemotherapy; physical activity; prehabilitation

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who are evaluable for both baseline and post-intervention assessments

  Evaluability will be measured for all patients enrolled in the study regardless of intervention assignment. Patients will be considered evaluable if they complete both the pre-intervention baseline assessments (frailty, PROs) and the post-intervention pre-surgery assessments. The proportion of patients evaluable, according to the above definition, over all patients enrolled will be calculated.

  Through study completion, average of 9-12 weeks

• Proportion of patients who are adherent to the Fit4Surgery intervention measured among those in the Fit4Surgery arm.

  Adherence will be measured in the Fit4Surgery arm. Patients will be considered adherent to the Fit4Surgery intervention if they wear their Fitbit for \>70% of the days during the study period (i.e., \~44/63 days) and if they meet their physical activity goals (step count) on \>70% of the days during the study period. The proportion of patients in the Fit4Surgery arm who are adherent to the intervention, according to the above definition, will be calculated.

  Through study completion, average of 9-12 weeks

Secondary Outcomes (8)

• Change in frailty

  Baseline and once at 9-12 weeks

• Change in anxiety

  Baseline and once at 9-12 weeks

• Change in physical function

  Baseline and once at 9-12 weeks

• Change in fatigue

  Baseline and once at 9-12 weeks

• Adverse Events

  Once at 9-12 weeks

Study Arms (2)

FIT4SURGERY Intervention

EXPERIMENTAL

The Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls.

Behavioral: FIT4SURGERY

Healthy Lifestyle Control

ACTIVE COMPARATOR

The Healthy Lifestyle Control group engages in their usual activities and receives education about physical activity and a healthy lifestyle for ovarian cancer patients. They receive weekly check in calls.

Behavioral: Healthy Lifestyle Control

Interventions

FIT4SURGERY BEHAVIORAL

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.

FIT4SURGERY Intervention

Healthy Lifestyle Control BEHAVIORAL

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.

Healthy Lifestyle Control

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female; ≥ 60 years of age
• Diagnosed with ovarian, fallopian tube or primary peritoneal cancer and undergoing planned neoadjuvant chemotherapy and are expecting to undergo planned surgery
• Fluent in spoken and written English
• Own a smartphone
• Have access to the internet to complete assessments

You may not qualify if:

• Patients receiving planned chemotherapy only
• Patients with uncontrolled cardiovascular disease, who are non-ambulatory, or who have severe cognitive or functional limitations precluding their ability to participate in a physical activity intervention
• Pregnant women or prisoners
• Patients whose oncologist has not provided clearance for their participation

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Behavior

Study Officials

• Emma Barber, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: October 26, 2021
• Study Start: December 10, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)