Pink Warrior 2: Teleconference-based Gaming Support

Breast Cancer Clinical Trial

— PW2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259905
• Other study ID #: 16-0040-02
• Secondary ID: 5P30AG024832
• Status: Completed
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: March 29, 2022

Study information

• Verified date: May 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 29, 2022
• Est. primary completion date: January 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	M.D. Anderson Cancer Center, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking Skills in Daily Life	Walking skills as measured by the Figure-of-8 Walk test	Baseline to 14 weeks
Other	Hand Grip Strength	Flexor muscle strength of hand and forearm measured by dynamometer	Baseline to 14 weeks
Other	Physical Function as Measured by the Senior Fitness Test	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
Other	Body Weight in kg	Mean body weight as measured by a calibrated scale in a cancer clinic setting	Baseline to 14 weeks
Other	Waist Circumference in cm	Mean waist circumference as measured by Seca-203 measuring tape	Baseline to 14 weeks
Other	Dietary Pattern	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
Other	Self-reported Physical Activity Minutes	Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire	Baseline to 14 weeks
Other	Self-reported Physical Function	Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function)	Baseline to 14 weeks
Other	Fatigue	Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue)	Baseline to 14 weeks
Other	Exercise Motivation Measured as Autonomous Regulation	Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2	Baseline to 14 weeks
Other	Psychological Feelings Related to Exercise	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
Other	Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS)	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
Other	Feasibility - Adherence	Adherence as measured by number of participants who complete at least 80% of program activities	Baseline to 14 weeks
Other	Feasibility - Attrition	Attrition as measured by percentage of people who drop out of the program	Baseline to 14 weeks
Other	Feasibility - Technological Issues	Technological issues will be measured by counting the number of reported occurrences	Baseline to 14 weeks
Other	Feasibility - Adverse Events	Adverse events will be measured by counting the number of occurrences	Baseline to 14 weeks
Other	Acceptability Scale	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
Primary	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	Baseline to 14 weeks
Secondary	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.	Baseline to 14 weeks
Secondary	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.	Baseline to 14 weeks