192 Participants Needed

Exercise Program for Gynecologic Cancer

AG
Overseen ByAnne Grace, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12567

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.12347

Who Is on the Research Team?

Emma Barber, MD: Robert H. Lurie ...

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
See 2 more

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.
See 1 more

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?
4Treatment groups
Experimental Treatment
Group I: Symptom burden-tailored goal setting appExperimental Treatment1 Intervention
Group II: Provider/oncologist engagementExperimental Treatment1 Intervention
Group III: Exercise PartnerExperimental Treatment1 Intervention
Group IV: CoachingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Published Research Related to This Trial

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

Citations

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. [2023]
Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. [2018]
Physical Activity Correlates, Barriers, and Preferences for Women With Gynecological Cancer. [2018]
Associations between physical activity and quality of life in ovarian cancer survivors. [2015]
Phase II trial evaluating efficacy of a Fitbit program for improving the health of endometrial cancer survivors. [2021]
Physical activity for an ethnically diverse sample of endometrial cancer survivors: a needs assessment and pilot intervention. [2021]
Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. [2017]
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