An interventional study of Active video game-based intervention and Pedometer in Breast Cancer and Physical Activity, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Other
Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior.
The goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors.
Increasing and maintaining physical activity among female breast cancer (BC) survivors during treatment remains an unresolved problem in BC survivorship care. BC survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decline of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-less than 30% of survivors met physical activity recommendations. Physical activity interventions have shown effectiveness in helping BC survivors increase activity during treatment, but limited evidence-based activity interventions have been disseminated into the clinic and community. To address this limitation, we are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior, which will investigate the feasibility of implementing active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Participants (N = 60) will be randomized to participate in the support group using the active video game-based physical activity intervention or to participate in the existing UTMB breast cancer support group with pedometers. Our specific aims are:
Aim 1: Evaluate the feasibility and acceptability of active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Measures of feasibility will include weekly attendance records, number of completed home-based worksheets, number of participants completing the program activities, technological issues, and adverse events.
Aim 2: Compare the support group using the active video game-based physical activity intervention to the existing UTMB breast cancer support group with pedometer. Primary outcomes will be changes in physical activity. Secondary outcomes will be changes in physical function, dietary pattern, and quality of life.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
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Exclusion Criteria:
This arm will receive the active video game-based intervention, which will include attending 12 weekly group sessions at the UTMB Breast Health Clinic, participate in self-paced home session, and monitor daily, weekly, and monthly steps using Wii Fit Meter. All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.
Behavioral: Active video game-based intervention
This arm will receive the pedometer intervention, which will include attending 3 monthly UTMB Breast Cancer Support Group sessions, and monitor daily, weekly, and monthly steps using a pedometer (Digit-Walker CW-700/701). All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.
Behavioral: Pedometer
* Attend 12 weekly group session at the UTMB Breast Health Clinic to play the active video games using Wii Fit U or Xbox 360. * Participate in self-paced home sessions * Monitor daily, weekly, and monthly steps using Wii Fit Meter * Feedback on physical activity and physical function
* Attend 3 monthly UTMB Breast Cancer Support Group Sessions * Monitor daily, weekly, and monthly steps using a pedometer (Digi-walker CW-700/701) * Feedback on physical activity and physical function
Change in physical activity steps per day as measured by an Actigraph monitor
Change in steps per day between 14 weeks and baseline as measured by an Actigraph monitor
Time frame: Change in steps per day from baseline to 14 weeks
Change in physical activity minutes as measured by an Actigraph monitor
Change in physical activity minutes between 14 weeks and baseline as measured by an Actigraph monitor
Time frame: Change in physical activity minutes from baseline to 14 weeks
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
The SPPB consists of six components: repeated chair sit and stands, balance test, semi-tandem stand, tandem stand, side-by-side stand, and eight feet walk
Time frame: Change in physical function from baseline and 14 weeks
Change in dietary pattern as measured by the Dietary Screener Questionnaire
Change in dietary pattern from baseline and 14 weeks\] \[Safety Issue: No\] The Dietary Screener Questionnaire used in the National Health and Nutrition Examination Survey 2009-10. The screener captures frequency of fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days
Time frame: Change in dietary pattern from baseline and 14 weeks
Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure
Changes in physical, social, emotional, functional, and additional well-being between 14 weeks and baseline as measured by FACT-B
Time frame: Change in quality of life from baseline and 14 weeks
Change in hand grip strength as measured by hand dynamometer
Hand dynamometer estimates the muscle strength generated from flexor muscles of the hand and the forearm
Time frame: Change in hand grip strength from baseline to 14 weeks
Change in weight
Change in body weight between 14 weeks and baseline as measured by a weight scale in the clinic
Time frame: Change in weight from baseline to 14 weeks
Change in waist circumference
Change in waist circumference between 14 weeks and baseline as measured by Seca-203
Time frame: Change in waist circumference from baseline to 14 weeks
Change in physical activity minutes, measured by the Community Healthy Activities Model Program for Seniors
Self-reported physical activity questionnaire
Time frame: Change in physical activity minutes from baseline to 14 weeks
Change in physical function, measured by PROMIS measure specific to cancer survivors
Changes in overall self-reported physical functions between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Physical Function
Time frame: Change in physical function from baseline to 14 weeks
Change in fatigue, measured by PROMIS measure specific to cancer survivors
Changes in overall self-reported fatigue level between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Fatigue
Time frame: Change in fatigue from baseline to 14 weeks
Change in exercise motivation, measured by autonomous motivation specific to physical activity
Behavioral regulation in Exercise Questionnaire-2 will be used
Time frame: Change in motivation from baseline to 14 weeks
Change in psychological feelings, measured by Psychological Need Satisfaction in Exercise Scale
Sub-scales included perceived competence, perceived autonomy, and perceived relatedness
Time frame: Change in psychological feelings from baseline to 14 weeks
Change in self-regulation, measured by Rovinak et al. scale
Sub-scales include exercise goals and exercise plans
Time frame: Change in self-regulation from baseline to 14 weeks
Feasibility-Adherence
Adherence will be measured by number of participants who completed at least 80% of the program activities.
Time frame: 14 weeks
Feasibility-Attrition
Attrition will be measured by percentage of people who dropped out of the intervention program.
Time frame: 14 weeks
Feasibility-Technological Issues
Technological issues will be measured by counting number of occurrence
Time frame: 14 weeks
Feasibility-Adverse Events
Adverse events will be measured by counting number of occurrence
Time frame: 14 weeks
Acceptability
Participant acceptability and satisfaction will be assessed by a questionnaire with 5-point scale responses
Time frame: 14 weeks
Plan to share: No
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The University of Texas Medical Branch, Galveston