Physical Activity Intervention for Ovarian Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Psychiatric illness, Life expectancy, Heart rate, Blood pressure, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a personalized exercise program might improve quality of life and activity levels for individuals with newly diagnosed or recurrent stage II-IV ovarian, primary peritoneal, fallopian tube, or endometrial cancer. Researchers aim to determine if a tailored activity plan, supported by wearable technology, can increase physical activity more effectively than standard exercise advice. They are also examining the effects of exercise on the gut microbiome (the community of bacteria in the gut) and the immune system. Candidates for this trial should have one of these specific cancer diagnoses and be comfortable using a fitness tracker like a Fitbit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cancer care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this physical activity intervention is safe for patients with ovarian cancer?

Research has shown that increased physical activity can reduce the risk of some cancers and extend lifespan. One study on cancer survivors explored using technology like fitness trackers and apps to encourage more exercise. This method succeeded, with participants walking an average of 1,593 extra steps each day. Exercise also helps ovarian cancer patients by increasing muscle strength and improving digestion. This suggests that automated, personalized exercise plans are likely safe and could offer several health benefits. No reports of serious side effects have emerged from this approach, making it a promising way to boost physical activity and improve quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized physical activity (PA) interventions can potentially enhance the standard care for ovarian cancer patients. Unlike typical PA recommendations that provide general guidelines, this approach tailors exercise goals to each patient, gradually increasing their activity with positive feedback. The use of wearable technology like the Fitbit Sense 2 and continuous glucose monitoring (CGM) devices allows for real-time tracking and personalized adjustments, aiming to sustain and potentially boost physical activity levels more effectively. This personalized method could lead to improved health outcomes by encouraging sustained engagement and motivation among patients.

What evidence suggests that this physical activity intervention is effective for improving quality of life in ovarian cancer patients?

Research has shown that increased physical activity can reduce the risk of some cancers and help people live longer. This trial will compare two approaches to physical activity for ovarian cancer patients. Participants in Arm I will receive a personalized physical activity intervention, using technology like fitness trackers. Studies have found that such technology can greatly increase activity levels in cancer survivors; for instance, one study showed participants walked an extra 1,593 steps each day. Meanwhile, participants in Arm II will receive standard physical activity counseling. Exercise also improves muscle strength and gut health, which are important for cancer patients. These benefits suggest that a customized exercise program could enhance the quality of life and physical abilities for those with ovarian or related cancers. ^{1 3 5 6 7}

Who Is on the Research Team?

Emese Zsiros

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with stage II-IV ovarian, primary peritoneal, fallopian tube cancer or newly diagnosed endometrial cancer. Participants should be interested in a physical activity program using wearable technology compared to standard care.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study

Willing to wear the activity tracking device for at least 70% of their waking hours each day throughout the 6-month study period

Exclusion Criteria

Serious psychiatric illness that is not currently stabilized

Life expectancy of less than 12 months

Resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard PA counseling or personalized PA intervention with wearable technology for 6 months

6 months

Continuous monitoring with wearable devices

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Automated Personalized Physical Activity Intervention

Trial Overview The study tests an automated personalized physical activity intervention against standard care. It uses wearables to encourage exercise and assesses its impact on quality of life, physical function, the gut microbiome, and immune function in certain cancer patients.

How Is the Trial Designed?

Group I: Arm I (Personalized Physical Activity intervention) Experimental Treatment 7 Interventions

Patients receive personalized PA goals and positive feedback to increase participation in MVPA in 10-15 minute increments up to 150 minutes per week for 12 weeks then sustain participation for an additional 12 weeks (6 months total). Patients also receive ongoing support to maintain or further increase PA levels up to month 6. Patients wear a Fitbit Sense 2 and CGM device continuously throughout the 6 month intervention. Additionally, patients undergo blood sample collection throughout the study.

Group II: Arm II (Standard PA) Active Control 5 Interventions

Patients receive general PA counseling recommending 150 minutes of activity per week consistent with standard of care at time of enrollment. Patients also wear a Fitbit Sense 2 and CGM device for 6 months. Additionally, patients undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 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]

The ECHO trial is a phase III randomized controlled trial involving 500 women with newly diagnosed ovarian cancer, aiming to assess the impact of a structured exercise program on progression-free survival and physical well-being during first-line chemotherapy.

Participants in the exercise group will engage in 150 minutes of moderate-intensity exercise weekly, with outcomes including not only cancer progression but also quality of life, fatigue, and overall health, highlighting the potential benefits of exercise in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. Hayes, S., Obermair, A., Mileshkin, L., et al.[2023]

Nearly 40% of women with ovarian cancer reduced their physical activity in the first year after diagnosis, and about 25% continued to have lower activity levels even 2-4 years later.

Higher levels of physical activity after diagnosis were linked to lower depression scores and better quality of life, suggesting that maintaining or increasing activity may positively impact psychosocial health in ovarian cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in women with ovarian cancer and its association with decreased distress and improved quality of life. Beesley, VL., Price, MA., Butow, PN., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06855706

An Automated Personalized Physical Activity Intervention ... In fact, increased levels of physical activity have been shown to decrease the risk of some cancers as well as increase overall survival in some cancers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658306/

Effects of personalized exercise prescriptions and social ... This study aimed to examine the effects of a multi-component mobile health intervention (wearable, apps, and social media) on cancer survivors' (CS') physical ...

3. withpower.com withpower.com/trial/phase-carcinoma-ovarian-epithelial-3-2025-5875d

Physical Activity Intervention for Ovarian Cancer Participants, including those undergoing chemotherapy, showed significant improvements in physical activity levels, with an increase of 1,593 average steps per ...

4. dctd.cancer.gov dctd.cancer.gov/research/spores/state/roswell-uchicago-ovarian

Roswell Park-University of Chicago Ovarian Cancer SPORE Exercise has been shown to improve outcomes in ovarian cancer (OC) patients by improving muscle mass, fat composition, gut microbiome diversity, ...

5. link.springer.com link.springer.com/article/10.1007/s00520-023-07790-8

Efficacy of exercise interventions for women during and ... Preliminary research into the role of exercise post-gynaecological cancer suggests an improvement in exercise capacity, muscular strength, and agility.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2095254623000716

Effects of personalized exercise prescriptions and social ... This study aimed to examine the effects of a multi-component mobile health intervention (wearable, apps, and social media) on cancer survivors' (CS') physical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10806642/

Pre-post feasibility trial of a telephone-delivered exercise ... A telephone-delivered exercise intervention for patients during chemotherapy for recurrent ovarian cancer: the ECHO-R trial protocol.