Clinical trial NCT04259905: Pink Warrior 2: Teleconference-based Gaming Support
Official title: Pink Warrior 2.0: Teleconference Support Group Toolkit for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Physical Activity
Keywords: active video game
telemedicine
cancer survivor
women's health
support group
survivorship
mhealth
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: National Institute on Aging (NIA)
First posted: 2020-02-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 79
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.

Aim 3: Develop tools for implementation of the Pink Warrior intervention within the clinic and community settings. A trainer's manual for the Pink Warrior intervention will be developed and UTMB Breast Cancer Support Group facilitators will be trained by research staff to implement the program.

Eligibility criteria: Inclusion Criteria:

1. Provide informed consent
2. Diagnosed with primary female breast cancer
3. 55 years to 79
4. Able to speak, read, and write in English
5. Able to travel to UTMB locations and/or MD Anderson Victory Lakes
6. Able to move arms and les as well as ambulate
7. Has a smartphone, tablet or computer and daily access to a reliable internet

Exclusion Criteria:

1. Pregnancy
2. Diagnosed dementia
3. Currently engage in 150 minutes or more of planned moderate intensity physical activity
4. Currently involved in another physical activity intervention

Primary outcomes:
measure: Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks
timeFrame: Baseline to 14 weeks
Secondary outcomes:
measure: Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks
timeFrame: Baseline to 14 weeks
measure: Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks
timeFrame: Baseline to 14 weeks
Other outcomes:
measure: Walking Skills in Daily Life
timeFrame: Baseline to 14 weeks
measure: Hand Grip Strength
timeFrame: Baseline to 14 weeks
measure: Physical Function as Measured by the Senior Fitness Test
timeFrame: Baseline to 14 weeks
measure: Body Weight in kg
timeFrame: Baseline to 14 weeks
measure: Waist Circumference in cm
timeFrame: Baseline to 14 weeks
measure: Dietary Pattern
timeFrame: Baseline to 14 weeks
measure: Self-reported Physical Activity Minutes
timeFrame: Baseline to 14 weeks
measure: Self-reported Physical Function
timeFrame: Baseline to 14 weeks
measure: Fatigue
timeFrame: Baseline to 14 weeks
measure: Exercise Motivation Measured as Autonomous Regulation
timeFrame: Baseline to 14 weeks
measure: Psychological Feelings Related to Exercise
timeFrame: Baseline to 14 weeks
measure: Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS)
timeFrame: Baseline to 14 weeks
measure: Feasibility - Adherence
timeFrame: Baseline to 14 weeks
measure: Feasibility - Attrition
timeFrame: Baseline to 14 weeks
measure: Feasibility - Technological Issues
timeFrame: Baseline to 14 weeks
measure: Feasibility - Adverse Events
timeFrame: Baseline to 14 weeks
measure: Acceptability Scale
timeFrame: Baseline to 14 weeks
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Texas
name: Elizabeth J Lyons, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: