Exercise Program for Gynecologic Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Disqualifiers: Uncontrolled cardiovascular disease, brain metastases, cognitive limitations, others
No Placebo Group
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.
12345Is 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.
12356How 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.
13467Eligibility 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
+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.
+1 more
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Symptom burden-tailored goal setting appExperimental Treatment1 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 engagementExperimental Treatment1 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 PartnerExperimental Treatment1 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: CoachingExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
References
Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. [2023]To systematically synthesise evidence of exercise intervention efficacy for physical/psychosocial outcomes that matter to women during/following treatment for gynaecological cancer.
Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. [2018]To establish the feasibility and acceptability of completing a higher dose of the planned physical activity volume among women with ovarian cancer, including those undergoing active treatment. .
Physical Activity Correlates, Barriers, and Preferences for Women With Gynecological Cancer. [2018]Physical activity is associated with improved health outcomes for people with cancer. We aimed to identify physical activity correlates, barriers, and preferences among women with gynecological cancer.
Associations between physical activity and quality of life in ovarian cancer survivors. [2015]To estimate the prevalence of physical activity in ovarian cancer survivors and to determine if there is a dose-response relationship between physical activity and quality of life.
Phase II trial evaluating efficacy of a Fitbit program for improving the health of endometrial cancer survivors. [2021]Despite the favorable prognosis of early stage endometrial cancer, mortality from cardiovascular disease is high. We aimed to evaluate the efficacy of a Fitbit program to improve physical activity in endometrial cancer survivors.
Physical activity for an ethnically diverse sample of endometrial cancer survivors: a needs assessment and pilot intervention. [2021]To determine the physical activity (PA) behavior, needs and preferences for underserved, ethnically diverse women with a history of endometrial cancer (EC).
Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors. [2017]Determine the feasibility of a 12-week physical activity intervention for obese, socioculturally diverse endometrial cancer survivors and to evaluate whether the intervention improves physical activity behavior, physical function, waist circumference, and quality of life.