Exercise Program for Gynecologic Cancers

(EMPOWER Trial)

Overseen By Nathalie Halley

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Excessive physical activity, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized digital exercise program, combined with a virtual support group, can improve outcomes for individuals undergoing treatment for gynecologic cancers. Participants will use a mobile app that syncs with a FitBit to track their activity and join online support sessions. The trial will compare this program to standard care, which provides exercise guidelines and activity tracking. This program may suit those recently diagnosed with gynecologic cancer who are beginning or in the early stages of treatment and wish to incorporate exercise into their routine. As an unphased trial, it offers participants the chance to explore innovative support methods that could enhance their treatment experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise and support for patients undergoing treatment for gynecologic cancer.

What prior data suggests that this exercise program is safe for patients with gynecologic cancer?

In a previous study, about two-thirds of women with recurring ovarian cancer found it safe to exercise during chemotherapy. Exercise often benefits cancer patients by reducing pain and increasing energy. Research has also shown that strength and agility can improve after gynecological cancer.

The treatment in this trial includes a personalized exercise program using a mobile app and a Fitbit. These tools track heart rate, steps, and movement. Participants also receive support from an online peer group. Overall, exercise is generally safe and well-tolerated for patients with gynecologic cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise Program for Gynecologic Cancers because it leverages technology and community support to enhance patient outcomes. Unlike traditional treatments that might focus solely on surgery, chemotherapy, or radiation, this program incorporates the "Move" mobile app and FitBit technology to track physical activity and heart rate. Participants also gain access to a peer support network through UCSF, offering social interaction and encouragement, which is not typically part of standard care. This innovative approach aims to empower patients by integrating physical activity with emotional support, potentially improving both physical health and quality of life during cancer treatment.

What evidence suggests that this exercise program is effective for gynecologic cancer patients?

Research has shown that exercise benefits people with gynecologic cancers. Studies have found that exercise can enhance physical abilities like strength and agility after cancer treatments. It may also reduce nerve problems, such as pain and weakness, caused by chemotherapy in ovarian cancer patients. For each improvement in fitness, the risk of dying from various cancers, including gynecologic ones, decreases by 13–18%. Additionally, exercise can boost energy levels, reduce pain, and improve overall quality of life for cancer patients. These findings suggest that exercise could effectively support recovery and improve treatment outcomes for those with gynecologic cancers. Participants in this trial will join different arms, including the EMPOWER intervention and Enhanced Usual Care (EUS), to evaluate the effectiveness of exercise programs in this context. ^{1 3 4 6 7}

Who Is on the Research Team?

Stephanie Cham, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed gynecologic cancer who are receiving treatment at the University of California, San Francisco. The study aims to include a diverse group of participants.

Inclusion Criteria

I understand and can follow the study's procedures.

Ability to understand a written informed consent document and willingness to sign it

I am starting or in my first cycle of systemic treatment.

Exclusion Criteria

I can use the DHT platform on my own or with a caregiver's help.

Inability to speak and read English

Existing performance of excessive physical activity (>210 minutes per week of moderate to vigorous intensity exercise at baseline)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1: EMPOWER Feasibility Cohort

Participants receive the EMPOWER intervention with the 'Move' mobile application and online peer support network

16 weeks

Online peer support sessions every 4 weeks

Stage 2: Randomized Trial

Participants are randomized to either the EMPOWER program or Enhanced Usual Care (EUS)

16 weeks

Online peer support sessions every 4 weeks for EMPOWER group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and Movement

Trial Overview

The effectiveness of a personalized digital exercise program and virtual support group is being tested. Participants will use a mobile app, wear an activity tracker, receive health coaching, and get educational handouts.

How Is the Trial Designed?

Group I: Stage 2: EMPOWER Experimental Treatment 3 Interventions

Participants randomized to the EMPOWER intervention will receive the "Move" mobile application that synchronizes with a FitBit that tracks heart rate, step count, and motion and also receive UCSF-based, online peer support network with individual and small group sessions that occur every four weeks. Questionnaires will be given at baseline, week 9, the end of treatment, and at 3 months after completion of the interventions.

Group II: Stage 1: EMPOWER Feasibility Cohort Experimental Treatment 3 Interventions

The first 20 participants enrolled with receive the EMPOWER intervention which consists of the "Move" mobile application that synchronizes with a FitBit that tracks heart rate, step count, and motion and also receive UCSF-based, online peer support network with individual and small group sessions that occur every four weeks. Questionnaires will be given at baseline, week 9, the end of treatment, and at 3 months after completion of the interventions.

Group III: Stage 2: Enhanced usual care (EUS) Active Control 2 Interventions

Participants randomized to the EUS group will receive a similar kit that includes a FitBit (equivalent features to what the intervention arm receives), and receive a handout that details recommended national guidelines on exercise during cancer treatment. Participants will be asked to allow the FitBit to be linked to a study email that provides a summary of weekly activity to track activity throughout the study.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Sword Health, SA

Industry Sponsor

Trials

14

Recruited

410,000+

Published Research Related to This Trial

An individualized exercise program for endometrial cancer patients, starting six weeks post-surgery, showed high feasibility with 41% consent rate and 86% attendance, and no adverse events reported.

Participants experienced significant improvements in quality of life, including emotional and cognitive functioning, as well as reductions in visceral fat and increased physical fitness, with maximum weight loss of 8.4 kg after six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effectiveness of the Exercise Program in Endometrial Cancer; Feasibility and Acceptability Survivorship Trial (EPEC-FAST). Smits, A., Galaal, K., Winnan, S., et al.[2023]

Only 31.1% of ovarian cancer survivors surveyed met the recommended physical activity guidelines, indicating a need for increased engagement in physical activity among this population.

Survivors who adhered to these guidelines reported a significantly better quality of life, suggesting a positive dose-response relationship between physical activity and well-being, which warrants further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between physical activity and quality of life in ovarian cancer survivors. Stevinson, C., Faught, W., Steed, H., et al.[2015]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

A survey of 239 gynecologic cancer survivors revealed a strong interest in physical activity (PA) programs, indicating a desire for structured support in their recovery.

Interviews with 16 participants emphasized the need for PA counseling that includes information on the benefits, appropriate levels of activity, and available opportunities, highlighting the role of oncology nurses in facilitating these discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The physical activity preferences of gynecologic cancer survivors. Tyrrell, A., Keats, M., Blanchard, C.[2015]

Exercise interventions for women during or after treatment for gynaecological cancer show significant improvements in physical outcomes such as aerobic capacity, muscular strength, and agility, based on a review of 11 studies including randomized controlled trials and cohort studies.

There was no evidence that exercise worsened any outcomes, suggesting that exercise is a safe and beneficial intervention for this population, although the effects on quality of life and other measures were inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. Rose, GL., Stewart, EM., Clifford, BK., et al.[2023]

A review of 12 randomized controlled trials suggests that physical exercise interventions can improve fatigue, depression, and health-related quality of life in individuals with gynecologic cancer.

Despite these promising findings, the evidence is still considered preliminary due to the limited number of studies, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Physical Exercise Interventions for Individuals With Gynecologic Cancer: A Systematic Review and Meta-Analysis. Ma, RC., Li, XJ., Liu, R., et al.[2023]

A systematic review of six studies involving 1607 participants found that physical activity levels significantly decreased after gynaecological cancer treatment, with many patients remaining less active up to three years post-diagnosis.

Approximately 91% of participants did not meet physical activity guidelines two years after diagnosis, indicating a need for targeted rehabilitation and exercise interventions for gynaecological cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of gynaecological cancer treatment on physical activity levels: a systematic review of observational studies. Lin, KY., Edbrooke, L., Granger, CL., et al.[2020]

Citations

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Exercise therapy has potential benefits for patients with ovarian cancer who have chemotherapy-induced peripheral neuropathy (CIPN).

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