Clinical trial NCT02750241: Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
Official title: Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Physical Activity
Keywords: active video game
mHealth
cancer survivor
women's health
breast cancer
physical activity
support group
survivorship
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Provide informed consent
2. Diagnosed with primary female breast cancer within 0 to 6 months period of time
3. English-speaking between the ages of 18 and 70
4. Able to read and write in English
5. Obtained approval from oncologists for the participant to be involved in the physical activity based support group
6. Able to travel to the UTMB Breast Health Center
7. Able to move arms and legs as well as ambulate
8. Able to see TV screen from a distance of 2 to 4 feet

Exclusion Criteria:

1. Being pregnant
2. Dementia
3. Currently engage in ≥150 minutes of planned moderate physical activity per week for the prior week
4. Are involved in another physical activity intervention

Primary outcomes:
measure: Change in physical activity steps per day as measured by an Actigraph monitor
timeFrame: Change in steps per day from baseline to 14 weeks
measure: Change in physical activity minutes as measured by an Actigraph monitor
timeFrame: Change in physical activity minutes from baseline to 14 weeks
Secondary outcomes:
measure: Change in physical function as measured by the Short Physical Performance Battery (SPPB)
timeFrame: Change in physical function from baseline and 14 weeks
measure: Change in dietary pattern as measured by the Dietary Screener Questionnaire
timeFrame: Change in dietary pattern from baseline and 14 weeks
measure: Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure
timeFrame: Change in quality of life from baseline and 14 weeks
measure: Change in hand grip strength as measured by hand dynamometer
timeFrame: Change in hand grip strength from baseline to 14 weeks
Other outcomes:
measure: Change in weight
timeFrame: Change in weight from baseline to 14 weeks
measure: Change in waist circumference
timeFrame: Change in waist circumference from baseline to 14 weeks
measure: Change in physical activity minutes, measured by the Community Healthy Activities Model Program for Seniors
timeFrame: Change in physical activity minutes from baseline to 14 weeks
measure: Change in physical function, measured by PROMIS measure specific to cancer survivors
timeFrame: Change in physical function from baseline to 14 weeks
measure: Change in fatigue, measured by PROMIS measure specific to cancer survivors
timeFrame: Change in fatigue from baseline to 14 weeks
measure: Change in exercise motivation, measured by autonomous motivation specific to physical activity
timeFrame: Change in motivation from baseline to 14 weeks
measure: Change in psychological feelings, measured by Psychological Need Satisfaction in Exercise Scale
timeFrame: Change in psychological feelings from baseline to 14 weeks
measure: Change in self-regulation, measured by Rovinak et al. scale
timeFrame: Change in self-regulation from baseline to 14 weeks
measure: Feasibility-Adherence
timeFrame: 14 weeks
measure: Feasibility-Attrition
timeFrame: 14 weeks
measure: Feasibility-Technological Issues
timeFrame: 14 weeks
measure: Feasibility-Adverse Events
timeFrame: 14 weeks
measure: Acceptability
timeFrame: 14 weeks
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch
name: Maria Swartz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swartz MC, Lewis ZH, Deer RR, Stahl AL, Swartz MD, Christopherson U, Basen-Engquist K, Wells SJ, Silva HC, Lyons EJ. Feasibility and Acceptability of an Active Video Game-Based Physical Activity Support Group (Pink Warrior) for Survivors of Breast Cancer: Randomized Controlled Pilot Trial. JMIR Cancer. 2022 Aug 22;8(3):e36889. doi: 10.2196/36889.