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

Trial Summary

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 data supports the effectiveness of the treatment Exercise and Movement for gynecologic cancers?

Research shows that exercise, including both aerobic (activities that increase heart rate) and resistance training (strength-building exercises), can improve physical performance and quality of life for women treated for gynecological cancer. Additionally, resistance exercise has been found to enhance muscle mass and strength in ovarian cancer survivors, which is important for overall health and recovery. ^{1 2 3 4 5}

Is exercise safe for people with gynecologic cancer?

There is limited information on the safety of exercise for people with gynecologic cancer, but a review is being conducted to better understand how safety issues are reported in exercise trials for cancer patients. ^{3 4 6 7 8}

How is the exercise program treatment for gynecologic cancers different from other treatments?

The exercise program for gynecologic cancers is unique because it focuses on improving physical and emotional well-being through a combination of aerobic and resistance training, rather than using medication or surgery. This approach aims to enhance quality of life and physical fitness, which are not typically addressed by standard cancer treatments. ^{3 4 6 9 10}

What is the purpose of this trial?

This is a single-center, pilot, hybrid type 1 design implementation study to evaluate the feasibility and implementation of a personalized digital exercise program and a virtual support group to improve patient-centered outcomes in patients receiving treatment for gynecologic cancer receiving treatment at University of California, San Francisco.

Research Team

Stephanie Cham, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 wearable device 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 wearable device 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 wearable activity tracker (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 their activity tracker 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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Supervised resistance exercise for women with ovarian cancer who have completed first-line treatment: a pragmatic study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Geriatric co-management leads to safely performed cytoreductive surgery in older women with advanced stage ovarian cancer treated at a tertiary care cancer center. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Combined aerobic and resistance training improves physical capacity in women treated for gynecological cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Associations between physical activity and quality of life in ovarian cancer survivors. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of Physical Exercise Interventions for Individuals With Gynecologic Cancer: A Systematic Review and Meta-Analysis. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The physical activity preferences of gynecologic cancer survivors. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Effectiveness of the Exercise Program in Endometrial Cancer; Feasibility and Acceptability Survivorship Trial (EPEC-FAST). [2023]

10. Brazil pubmed.ncbi.nlm.nih.gov

The impact of gynaecological cancer treatment on physical activity levels: a systematic review of observational studies. [2020]