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Pink Warrior 2: Teleconference-based Gaming Support (PW2)

Primary Purpose

Breast Cancer, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active video game teleconference support group
Standard support group + pedometer
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring active video game, telemedicine, cancer survivor, women's health, support group, survivorship, mhealth

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Medical Branch
  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active video game teleconference support group

Standard support group + pedometer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Walking Physical Activity as Measured by Change in Daily Steps From 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

Secondary Outcome Measures

Quality of Life as Measured by the Change in FACT-B Scores From 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.
Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From 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.

Full Information

First Posted
January 30, 2020
Last Updated
May 12, 2023
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
M.D. Anderson Cancer Center, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04259905
Brief Title
Pink Warrior 2: Teleconference-based Gaming Support
Acronym
PW2
Official Title
Pink Warrior 2.0: Teleconference Support Group Toolkit for Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
January 29, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
M.D. Anderson Cancer Center, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Physical Activity
Keywords
active video game, telemedicine, cancer survivor, women's health, support group, survivorship, mhealth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active video game teleconference support group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard support group + pedometer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active video game teleconference support group
Intervention Description
12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device
Intervention Type
Behavioral
Intervention Name(s)
Standard support group + pedometer
Intervention Description
3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer
Primary Outcome Measure Information:
Title
Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks
Description
Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment
Time Frame
Baseline to 14 weeks
Secondary Outcome Measure Information:
Title
Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks
Description
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.
Time Frame
Baseline to 14 weeks
Title
Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks
Description
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.
Time Frame
Baseline to 14 weeks
Other Pre-specified Outcome Measures:
Title
Walking Skills in Daily Life
Description
Walking skills as measured by the Figure-of-8 Walk test
Time Frame
Baseline to 14 weeks
Title
Hand Grip Strength
Description
Flexor muscle strength of hand and forearm measured by dynamometer
Time Frame
Baseline to 14 weeks
Title
Physical Function as Measured by the Senior Fitness Test
Description
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
Time Frame
Baseline to 14 weeks
Title
Body Weight in kg
Description
Mean body weight as measured by a calibrated scale in a cancer clinic setting
Time Frame
Baseline to 14 weeks
Title
Waist Circumference in cm
Description
Mean waist circumference as measured by Seca-203 measuring tape
Time Frame
Baseline to 14 weeks
Title
Dietary Pattern
Description
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
Time Frame
Baseline to 14 weeks
Title
Self-reported Physical Activity Minutes
Description
Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire
Time Frame
Baseline to 14 weeks
Title
Self-reported Physical Function
Description
Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function)
Time Frame
Baseline to 14 weeks
Title
Fatigue
Description
Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue)
Time Frame
Baseline to 14 weeks
Title
Exercise Motivation Measured as Autonomous Regulation
Description
Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2
Time Frame
Baseline to 14 weeks
Title
Psychological Feelings Related to Exercise
Description
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.
Time Frame
Baseline to 14 weeks
Title
Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS)
Description
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.)
Time Frame
Baseline to 14 weeks
Title
Feasibility - Adherence
Description
Adherence as measured by number of participants who complete at least 80% of program activities
Time Frame
Baseline to 14 weeks
Title
Feasibility - Attrition
Description
Attrition as measured by percentage of people who drop out of the program
Time Frame
Baseline to 14 weeks
Title
Feasibility - Technological Issues
Description
Technological issues will be measured by counting the number of reported occurrences
Time Frame
Baseline to 14 weeks
Title
Feasibility - Adverse Events
Description
Adverse events will be measured by counting the number of occurrences
Time Frame
Baseline to 14 weeks
Title
Acceptability Scale
Description
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.)
Time Frame
Baseline to 14 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J Lyons, PhD, MPH
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pink Warrior 2: Teleconference-based Gaming Support

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