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

Trial Summary

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 data supports the effectiveness of the treatment Automated Personalized Physical Activity Intervention for ovarian cancer?

Research shows that physical activity can improve quality of life and reduce distress in women with ovarian cancer. Additionally, similar interventions using technology to promote physical activity have been effective in improving health outcomes in cancer survivors. ^{1 2 3 4 5}

Is physical activity safe for women with ovarian cancer?

Research on physical activity for women with ovarian cancer suggests it is generally safe and may improve quality of life, though specific safety data for the intervention under different names is not detailed in the available studies. ^{2 3 5 6 7}

How is the Automated Personalized Physical Activity Intervention treatment different from other treatments for ovarian cancer?

This treatment is unique because it focuses on increasing physical activity, which has been shown to improve quality of life and reduce distress in women with ovarian cancer, rather than using traditional medical or surgical approaches. ^{2 3 5 7 8}

What is the purpose of this trial?

This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases. 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. Currently, standard of care guidelines include participation in at least 150 minutes of moderate exercise weekly. An automated personalized physical activity intervention may increase physical activity, enhance quality of life, and improve physical function and daily living activities compared to standard recommendations in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer. This trial also evaluates the impact of physical activity on the gut microbiome and immune function. The microbiome is the collection of tiny organisms, like bacteria, that live in and on the body, especially places like the gut. These microorganisms play an important role in health. Information gathered from this study may help understand how the gut microbiome and physical activity influences the immune system in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer.

Research Team

Emese Zsiros

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. [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. United States pubmed.ncbi.nlm.nih.gov

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

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

A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Physical activity in women with ovarian cancer and its association with decreased distress and improved quality of life. [2015]

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

Exercise adherence in a randomized controlled trial of exercise on quality of life in ovarian cancer survivors. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Quantifying physical activity and the associated barriers for women with ovarian cancer. [2018]

8. 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]