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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different support methods can help older women with gynecologic cancer become more active during treatment. It tests a fitness program called Fit4Treatment, which includes a wearable activity tracker and may involve coaching, a supportive exercise partner, or feedback from the cancer care team. The goal is to determine which method best encourages physical activity, potentially improving quality of life and aiding cancer recovery. Women over 60 receiving treatment for certain types of gynecologic cancer and open to having an exercise partner might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer care and recovery for many.

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 prior data suggests that this exercise program is safe for older women with gynecologic cancer?

Research has shown that personalized physical activity can be safe and gradually increase activity levels in women with gynecologic cancer. The Fit4Treatment program encourages older women with this type of cancer to stay active during treatment, aiming to improve their health and quality of life.

No reports of serious side effects or problems have emerged from using Fit4Treatment. The program employs tools like a mobile app, coaching calls, and social support to safely increase activity. Participants generally find these methods easy to manage.

Overall, evidence suggests that the program is safe for its intended audience. Participants should feel encouraged by the program's supportive nature. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fit4Treatment approach for gynecologic cancer patients because it integrates personalized support systems that are not typically found in standard care. Unlike traditional treatments that focus solely on medical interventions, Fit4Treatment combines weekly coaching calls, provider engagement with real-time physical activity data, and the use of an exercise partner to promote physical activity. Additionally, the Fit4Treatment app offers tailored goal-setting based on real-time symptom feedback and activity tracking, which empowers patients to manage their physical activity in a way that aligns with their daily well-being. This holistic approach aims to enhance motivation, increase physical activity, and potentially improve treatment outcomes for patients.

What evidence suggests that this trial's treatments could be effective for improving physical activity in older gynecologic cancer patients?

Studies have shown that increased physical activity can improve health and survival in older women with gynecologic cancers. This trial will evaluate the Fit4Treatment program, which includes various components to help participants remain active. Participants may receive weekly coaching calls, engage with an exercise partner, or use a symptom burden-tailored goal-setting app. Additionally, some participants will share their physical activity data with their oncology provider. Previous research suggests that personalized programs like Fit4Treatment can boost step counts and overall activity levels, aiming to improve quality of life and potentially enhance cancer-specific survival. ^{1 2 3 4 5}

Who Is on the Research Team?

Emma Barber

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 do not have uncontrolled heart disease or other major health issues preventing physical activity.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05743517?tab=table

Physical Activity Intervention Among Older Women With ... The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-07375

Patient-Tailored Physical Activity to Improve Health and ... This trial tests how well patient tailored physical activity interventions work to improve health and survival among older women with gynecologic cancers ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/428395

Physical Activity Intervention Among Older Women With ... The Fit4Treatment app is designed to encourage physical activity among older women with gynecologic cancer while they are undergoing cancer therapy.

4. trialx.com trialx.com/clinical-trials/listings/276116/physical-activity-intervention-among-older-women-with-gynecologic-cancers-fit4treatment/

Physical Activity Intervention Among Older Women With ... This study will determine which components of a physical activity intervention (Fit4Treatment) meaningfully contribute to improving physical ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228313/

PMC Search Update - PubMed Central This review paper investigated existing literature on the relationship between physical activity, exercise, and gynecological cancers