Pink Warrior 2: Teleconference-based Gaming Support

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04259905

Acronym

PW2

Enrollment

Registered

2020-02-07

Start date

2020-05-11

Completion date

2022-03-29

Last updated

2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Physical Activity

Keywords

active video game, telemedicine, cancer survivor, women's health, support group, survivorship, mhealth

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.

Interventions

BEHAVIORALActive 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

BEHAVIORALStandard support group + pedometer

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks	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

Measure	Time frame	Description
Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks	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	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.

Other

Measure	Time frame	Description
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
Walking Skills in Daily Life	Baseline to 14 weeks	Walking skills as measured by the Figure-of-8 Walk test
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.)
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.
Hand Grip Strength	Baseline to 14 weeks	Flexor muscle strength of hand and forearm measured by dynamometer
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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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	10
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. Standard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer	10
Total	20

Baseline characteristics

Characteristic	Active Video Game Teleconference Support Group	Total	Standard Support Group + Pedometer
Age, Continuous	64.90 years STANDARD_DEVIATION 8.03	63.75 years STANDARD_DEVIATION 6.35	62.60 years STANDARD_DEVIATION 4.2
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants	19 Participants	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) White	8 Participants	16 Participants	8 Participants
Region of Enrollment United States	10 participants	20 participants	10 participants
Sex: Female, Male Female	10 Participants	20 Participants	10 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 10
other Total, other adverse events	0 / 10	0 / 10
serious Total, serious adverse events	0 / 10	0 / 10

Outcome results

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