- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04259905
Pink Warrior 2: Teleconference-based Gaming Support (PW2)
Pink Warrior 2.0: Teleconference Support Group Toolkit for Breast Cancer Survivors
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- The University of Texas Medical Branch
-
Houston, Texas, United States, 77054
- UT MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provide informed consent
- Diagnosed with primary female breast cancer
- 55 years to 79
- Able to speak, read, and write in English
- Able to travel to UTMB locations and/or MD Anderson Victory Lakes
- Able to move arms and les as well as ambulate
- Has a smartphone, tablet or computer and daily access to a reliable internet
Exclusion Criteria:
- Pregnancy
- Diagnosed dementia
- Currently engage in 150 minutes or more of planned moderate intensity physical activity
- Currently involved in another physical activity intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active video game teleconference support group
Participants will attend enhanced support group meetings via zoom teleconferencing software.
Support group meetings will include group play of active video games and discussion of survivorship topics.
Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.
|
12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device
|
Active Comparator: Standard support group + pedometer
Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center.
They will also receive a standard pedometer and a water bottle and tote bag.
|
3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks
Time Frame: Baseline to 14 weeks
|
Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment
|
Baseline to 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks
Time Frame: Baseline to 14 weeks
|
Quality of life score as measured by the Functional Assessment of Cancer Therapy-Breast measure at follow-up, scored for physical, social, emotional, functional, and breast well-being (here we report the total score of these subscales).
The range for this scale is 0-123, with 0 indicating a better outcome.
|
Baseline to 14 weeks
|
Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks
Time Frame: Baseline to 14 weeks
|
Difference in physical performance as measured by Short Physical Performance Battery from baseline to 14 weeks.
The numbers reported here are the sum of scores from the subscales.
The range for this measure is between 0-12, with lower scores indicating better outcomes.
|
Baseline to 14 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue
Time Frame: Baseline to 14 weeks
|
Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue)
|
Baseline to 14 weeks
|
Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS)
Time Frame: Baseline to 14 weeks
|
Goal-setting and planning measures, adapted from a published, untitled series of items created by Rovniak et al for evaluation of technology-mediated health promotion content.
10 EGS and 10 EPS items on a 5-point Likert scale.
Range: 1 (does not describe) to 5 (describes completely) of the goal setting and planning strategies.
The higher the score means more exercise goal-setting and planning behavior.
(Rovniak et al.
Annals of Behavioral Medicine, 2002, 24(2): 149-156.)
|
Baseline to 14 weeks
|
Walking Skills in Daily Life
Time Frame: Baseline to 14 weeks
|
Walking skills as measured by the Figure-of-8 Walk test
|
Baseline to 14 weeks
|
Hand Grip Strength
Time Frame: Baseline to 14 weeks
|
Flexor muscle strength of hand and forearm measured by dynamometer
|
Baseline to 14 weeks
|
Physical Function as Measured by the Senior Fitness Test
Time Frame: Baseline to 14 weeks
|
Physical function scores on six components: chair stands, arm curls, chair sit and reach, back scratch, 8 foot up and go, and 2 minute step in place test
|
Baseline to 14 weeks
|
Body Weight in kg
Time Frame: Baseline to 14 weeks
|
Mean body weight as measured by a calibrated scale in a cancer clinic setting
|
Baseline to 14 weeks
|
Waist Circumference in cm
Time Frame: Baseline to 14 weeks
|
Mean waist circumference as measured by Seca-203 measuring tape
|
Baseline to 14 weeks
|
Dietary Pattern
Time Frame: Baseline to 14 weeks
|
Dietary pattern change measured by the National Health and Nutrition Examination Survey (2009-10) measuring fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days
|
Baseline to 14 weeks
|
Self-reported Physical Activity Minutes
Time Frame: Baseline to 14 weeks
|
Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire
|
Baseline to 14 weeks
|
Self-reported Physical Function
Time Frame: Baseline to 14 weeks
|
Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical
Function)
|
Baseline to 14 weeks
|
Exercise Motivation Measured as Autonomous Regulation
Time Frame: Baseline to 14 weeks
|
Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2
|
Baseline to 14 weeks
|
Psychological Feelings Related to Exercise
Time Frame: Baseline to 14 weeks
|
Perceptions of autonomy, competence, and relatedness as measured by the Basic Psychological Needs in Exercise scale.
11 items on a 5-point Likert scale.
Range: 1 (I do not agree at all) to 5 (I completely agree) for each of the constructs-autonomy (1-20), competence (1-20), and relatedness (1-15).
The higher the score means more autonomy, more competence, and relatedness.
|
Baseline to 14 weeks
|
Feasibility - Adherence
Time Frame: Baseline to 14 weeks
|
Adherence as measured by number of participants who complete at least 80% of program activities
|
Baseline to 14 weeks
|
Feasibility - Attrition
Time Frame: Baseline to 14 weeks
|
Attrition as measured by percentage of people who drop out of the program
|
Baseline to 14 weeks
|
Feasibility - Technological Issues
Time Frame: Baseline to 14 weeks
|
Technological issues will be measured by counting the number of reported occurrences
|
Baseline to 14 weeks
|
Feasibility - Adverse Events
Time Frame: Baseline to 14 weeks
|
Adverse events will be measured by counting the number of occurrences
|
Baseline to 14 weeks
|
Acceptability Scale
Time Frame: Baseline to 14 weeks
|
Acceptability and satisfaction will be assessed via Vandelanotte questionnaire with 5-point scale responses, measures are adapted from a published, untitled series of items created by Vandelanotte et al for evaluation of technology-mediated health promotion content. Acceptability and feasibility of 3 components on a 5-point Likert scale-activity monitor (7-item), program team (6-item), and the program itself (15-item). Ranged: 1 (strongly disagree) to 5 (strongly agree). The higher the score means that it is more acceptable and feasible. (Vandelanotte, C. and I. De Bourdeaudhuij (2003). "Acceptability and feasibility of a computer-tailored physical activity intervention using stages of change: project FAITH." Health Educ Res 18(3): 304-317 and Vandelanotte, C., et al. (2004). "Acceptability and feasibility of an interactive computer-tailored fat intake intervention in Belgium." Health Promot Int 19(4): 463-470.) |
Baseline to 14 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth J Lyons, PhD, MPH, University of Texas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-0040-02
- 5P30AG024832 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of California, IrvineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-positive Breast CancerUnited States
-
Joseph Baar, MD, PhDCompletedBreast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Active video game teleconference support group
-
University of South CarolinaCompletedBreast CancerUnited States
-
Brigham Young UniversityCompleted
-
Bard CollegeUniversity of Texas at AustinCompleted
-
Professor Fernando Figueira Integral Medicine InstituteUniversidade Estadual da ParaibaCompletedPhysical Activity | Overweight and Obesity | Cardiovascular Risk FactorBrazil
-
Massachusetts Eye and Ear InfirmaryNot yet recruitingHigh-Frequency Hearing Loss
-
Federal University of ParaíbaCompleted
-
Baylor College of MedicineNational Cancer Institute (NCI)CompletedPhysical Inactivity in ChildrenUnited States
-
Dokuz Eylul UniversityCompletedCoronary Artery DiseaseTurkey
-
Mor NahumHadassah Medical Organization; Ludwig-Maximilians - University of Munich; Riga...RecruitingMajor Depressive DisorderGermany, Israel, Latvia
-
HopeLab FoundationStanford University; West Virginia University; Santech, IncCompletedHealth Behavior | Motivation | Adolescent BehaviorUnited States