Exercise Program for Gynecologic Cancer

Overseen By Anne Grace, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Uncontrolled cardiovascular disease, brain metastases, cognitive limitations, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

192 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.

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 seems focused on increasing physical activity for cancer patients, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment Fit4Treatment, Physical Activity Intervention Among Older Women With Gynecologic Cancers?

Research shows that exercise interventions can improve physical and mental health outcomes for women during and after gynecological cancer treatment. Additionally, physical activity is linked to better quality of life in ovarian cancer survivors, and a Fitbit program has been effective in increasing physical activity among endometrial cancer survivors. ^{1 2 3 4 5}

Is the exercise program for gynecologic cancer safe for participants?

The research does not specifically address safety concerns, but exercise programs like these are generally considered safe for cancer survivors and can improve health outcomes. ^{1 2 3 5 6}

How is the Fit4Treatment exercise program different from other treatments for gynecologic cancer?

The Fit4Treatment exercise program is unique because it focuses on physical activity to improve health outcomes for women with gynecologic cancer, unlike traditional treatments that may focus on medication or surgery. This program aims to enhance physical and psychosocial well-being during and after cancer treatment, which is not typically addressed by standard medical treatments. ^{1 3 4 6 7}

Research Team

Emma Barber

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for women over 60 with gynecologic cancers (endometrial/uterine, ovarian, cervical, vulvar/vaginal) who are fluent in English and undergoing systemic treatments like chemotherapy. They should be able to participate in physical activities and find an exercise partner if needed.

Inclusion Criteria

Willing to try to identify an exercise partner to participate with them, if needed

I am receiving or planning to receive treatment for a gynecologic cancer.

Fluent in English

Exclusion Criteria

Pregnant women or prisoners

I have cognitive or physical limitations that prevent me from participating in physical activities.

I have active cancer spread to my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week physical activity intervention using a wearable activity tracker and app, with components such as coaching, provider engagement, exercise partner, and symptom-burden tailored goal setting

12 weeks

Weekly coaching calls

Follow-up

Participants are monitored for changes in physical activity, quality of life, and other health outcomes after the intervention

12 weeks

Long-term Follow-up

Participants' health outcomes, including adverse events and survival, are monitored through medical record review

3 years

Treatment Details

Interventions

• Fit4Treatment

Trial Overview The Fit4Treatment study tests a core intervention using a wearable activity tracker and app, plus four additional components: a symptom-burden tailored app, an exercise partner's involvement, oncology provider engagement, and coaching to boost physical activity.

Participant Groups

Group I: Symptom burden-tailored goal setting app Experimental Treatment 1 Intervention

The Fit4Treatment app is designed to encourage physical activity among older women with gynecologic cancer while they are undergoing cancer therapy. The app will contain the following features 1) education about safely increasing physical activity and steps; 2) tailored patient-specific push notifications to encourage physical activity 3) syncing of Fitbit steps and transmission of these data to study staff in real time; 4) daily, weekly and monthly step progress; and 5) goal setting that incorporates prior physical activity, patient desires, and daily symptom burden. The app will prompt patients to report their symptom burden on a scale of 1-5 each morning. Based on their symptom rating and the previous days step counts (measured directly by the Fitbit) patients will be provided with three different goal choices to select. Daily activity goals increase, decrease or stay the same depending on the previous day and the patient's own goals.

Group II: Provider/oncologist engagement Experimental Treatment 1 Intervention

Participants assigned to the provider/oncologist engagement component will have their physical activity data recorded by the Fitbit shared with their oncology provider through the electronic medical record (EMR). For participants randomized to this condition, clinical staff will place an order into the EMR, allowing the patient to use the patient-facing portal MyChart to link their Fitbit to the health record. Prior to regularly scheduled clinic visits, the patient's oncology team will receive a message summarizing the participant's physical activity (average daily steps) for the prior three weeks.

Group III: Exercise Partner Experimental Treatment 1 Intervention

Participants assigned to the exercise partner component will be encouraged to discuss their step progress with their selected partner who will in turn support the participant and encourage them to stay active.

Group IV: Coaching Experimental Treatment 1 Intervention

Participants assigned to the coaching intervention will receive weekly coaching calls. The study team will call them at a previously specified and mutually agreed upon time once per week to review topics related to physical activity and cancer treatment. Coaching calls will have an educational component and cover topics such as reducing sedentary behavior, benefits of increased physical activity, managing cancer treatment symptoms, social support, stress management, etc. During these calls, the topics as well as strategies and recommendations will be discussed. Barriers and facilitators will be reflected on and planned for to increased self-efficacy. Participants will engage in direct problem solving with their coach. Discussing these topics will enhance outcome expectation and increase motivation.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

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]

A 26-week home-based exercise program requiring 225 minutes of physical activity per week was found to be feasible and acceptable for women with ovarian cancer, with 80% of participants successfully completing the program.

Participants, including those undergoing chemotherapy, showed significant improvements in physical activity levels, with an increase of 1,593 average steps per day and 15 additional minutes of moderate-intensity activity, all without any adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. Zhang, X., McClean, D., Ko, E., et al.[2018]

Women with gynecological cancer who were in the follow-up phase of treatment and those who were physically active before diagnosis were significantly more likely to meet the recommended physical activity levels of at least 150 minutes per week.

Common barriers to physical activity included fatigue and feeling unwell, particularly among women undergoing chemotherapy or radiation, highlighting the need for tailored strategies to encourage exercise in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Correlates, Barriers, and Preferences for Women With Gynecological Cancer. Farrokhzadi, L., Dhillon, HM., Goumas, C., et al.[2018]

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 Fitbit program aimed at increasing physical activity in endometrial cancer survivors showed a 22% increase in average daily steps at 6 months, but this improvement did not last by the 9-month mark.

The telephone communication method was more effective in boosting activity levels compared to electronic methods, particularly for participants with low baseline activity, suggesting that more intensive interventions may be needed for sustained lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial evaluating efficacy of a Fitbit program for improving the health of endometrial cancer survivors. Rahimy, E., Usoz, M., von Eyben, R., et al.[2021]

A study involving 99 women with a history of endometrial cancer revealed that 66% did not exercise regularly, despite 86% expressing interest in joining an exercise program, highlighting a significant need for physical activity interventions in this population.

An 8-week pilot physical activity intervention showed high adherence (83%) among participants, with all reporting weight loss and no adverse events, indicating that such programs can be safe and effective for improving health among ethnically diverse cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for an ethnically diverse sample of endometrial cancer survivors: a needs assessment and pilot intervention. Rossi, A., Moadel-Robblee, A., Garber, CE., et al.[2021]

A 12-week physical activity intervention for obese endometrial cancer survivors showed significant improvements in physical function, waist circumference, and quality of life, with large effect sizes compared to a control group.

Despite low recruitment rates, the intervention was feasible, with a majority of participants attending most sessions and reporting increased physical activity, indicating potential for further research in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. Rossi, A., Garber, CE., Ortiz, M., et al.[2017]

References

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

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

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

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Physical Activity Correlates, Barriers, and Preferences for Women With Gynecological Cancer. [2018]

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

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

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

Phase II trial evaluating efficacy of a Fitbit program for improving the health of endometrial cancer survivors. [2021]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Physical activity for an ethnically diverse sample of endometrial cancer survivors: a needs assessment and pilot intervention. [2021]

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

Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. [2017]