PW2: Pink Warrior 2: Teleconference-based Gaming Support

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04259905

Collaborator

M.D. Anderson Cancer Center (Other), National Institute on Aging (NIA) (NIH)

Enrollment

Locations

Arms

31.7

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Physical Activity	Behavioral: Active video game teleconference support group Behavioral: Standard support group + pedometer	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Pink Warrior 2.0: Teleconference Support Group Toolkit for Breast Cancer Survivors

Actual Study Start Date :

May 11, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.	Behavioral: Active video game teleconference support group 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.	Behavioral: Standard support group + pedometer 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer

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.

Behavioral: Active video game teleconference support group

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.

Behavioral: Standard support group + pedometer

3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer

Outcome Measures

Primary Outcome Measures

Walking physical activity as measured by daily steps at 14 weeks [Baseline to 14 weeks]
Mean of daily steps taken from Actigraph accelerometer worn for 7 day period

Secondary Outcome Measures

Physical function as measured by the Senior Fitness Test [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
Quality of life as measured by the FACT-B [Baseline to 14 weeks]
Quality of life score as measured by the Functional Assessment of Cancer Therapy-Breast measure, scored for physical, social, emotional, functional, and breast well-being
Hand grip strength [Baseline to 14 weeks]
Flexor muscle strength of hand and forearm measured by dynamometer
Walking skills in daily life [Baseline to 14 weeks]
Walking skills as measured by the Figure-of-8 Walk test
Physical performance [Baseline to 14 weeks]
Physical performance as measured by two sub components of the Short Physical Performance Battery: balance and timed 3 meter walk

Other Outcome Measures

Body weight in kg [Baseline to 14 weeks]
Mean body weight as measured by a calibrated scale in a cancer clinic setting
Waist circumference in cm [Baseline to 14 weeks]
Mean waist circumference as measured by Seca-203 measuring tape
Dietary pattern [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
Self-reported physical activity minutes [Baseline to 14 weeks]
Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire
Self-reported physical function [Baseline to 14 weeks]
Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function)
Fatigue [Baseline to 14 weeks]
Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue)
Exercise motivation measured as autonomous regulation [Baseline to 14 weeks]
Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2
Psychological feelings related to exercise [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.
Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS) [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.)
Feasibility - adherence [Baseline to 14 weeks]
Adherence as measured by number of participants who complete at least 80% of program activities
Feasibility - attrition [Baseline to 14 weeks]
Attrition as measured by percentage of people who drop out of the program
Feasibility - technological issues [Baseline to 14 weeks]
Technological issues will be measured by counting the number of reported occurrences
Feasibility - adverse events [Baseline to 14 weeks]
Adverse events will be measured by counting the number of occurrences
Acceptability scale [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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 79 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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