search
Back to results

Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

Primary Purpose

Breast Cancer, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active video game-based intervention
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, mHealth, cancer survivor, women's health, breast cancer, physical activity, support group, survivorship

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provide informed consent
  2. Diagnosed with primary female breast cancer within 0 to 6 months period of time
  3. English-speaking between the ages of 18 and 70
  4. Able to read and write in English
  5. Obtained approval from oncologists for the participant to be involved in the physical activity based support group
  6. Able to travel to the UTMB Breast Health Center
  7. Able to move arms and legs as well as ambulate
  8. Able to see TV screen from a distance of 2 to 4 feet

Exclusion Criteria:

  1. Being pregnant
  2. Dementia
  3. Currently engage in ≥150 minutes of planned moderate physical activity per week for the prior week
  4. Are involved in another physical activity intervention

Sites / Locations

  • The University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active video game-based intervention

Pedometer

Arm Description

This arm will receive the active video game-based intervention, which will include attending 12 weekly group sessions at the UTMB Breast Health Clinic, participate in self-paced home session, and monitor daily, weekly, and monthly steps using Wii Fit Meter. All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.

This arm will receive the pedometer intervention, which will include attending 3 monthly UTMB Breast Cancer Support Group sessions, and monitor daily, weekly, and monthly steps using a pedometer (Digit-Walker CW-700/701). All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.

Outcomes

Primary Outcome Measures

Change in physical activity steps per day as measured by an Actigraph monitor
Change in steps per day between 14 weeks and baseline as measured by an Actigraph monitor
Change in physical activity minutes as measured by an Actigraph monitor
Change in physical activity minutes between 14 weeks and baseline as measured by an Actigraph monitor

Secondary Outcome Measures

Change in physical function as measured by the Short Physical Performance Battery (SPPB)
The SPPB consists of six components: repeated chair sit and stands, balance test, semi-tandem stand, tandem stand, side-by-side stand, and eight feet walk
Change in dietary pattern as measured by the Dietary Screener Questionnaire
Change in dietary pattern from baseline and 14 weeks] [Safety Issue: No] The Dietary Screener Questionnaire used in the National Health and Nutrition Examination Survey 2009-10. The screener captures frequency of fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days
Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure
Changes in physical, social, emotional, functional, and additional well-being between 14 weeks and baseline as measured by FACT-B
Change in hand grip strength as measured by hand dynamometer
Hand dynamometer estimates the muscle strength generated from flexor muscles of the hand and the forearm

Full Information

First Posted
April 18, 2016
Last Updated
April 1, 2020
Sponsor
The University of Texas Medical Branch, Galveston
search

1. Study Identification

Unique Protocol Identification Number
NCT02750241
Brief Title
Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
Official Title
Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

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.

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, mHealth, cancer survivor, women's health, breast cancer, physical activity, support group, survivorship

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Active video game-based intervention
Arm Type
Experimental
Arm Description
This arm will receive the active video game-based intervention, which will include attending 12 weekly group sessions at the UTMB Breast Health Clinic, participate in self-paced home session, and monitor daily, weekly, and monthly steps using Wii Fit Meter. All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.
Arm Title
Pedometer
Arm Type
Active Comparator
Arm Description
This arm will receive the pedometer intervention, which will include attending 3 monthly UTMB Breast Cancer Support Group sessions, and monitor daily, weekly, and monthly steps using a pedometer (Digit-Walker CW-700/701). All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.
Intervention Type
Behavioral
Intervention Name(s)
Active video game-based intervention
Intervention Description
Attend 12 weekly group session at the UTMB Breast Health Clinic to play the active video games using Wii Fit U or Xbox 360. Participate in self-paced home sessions Monitor daily, weekly, and monthly steps using Wii Fit Meter Feedback on physical activity and physical function
Intervention Type
Behavioral
Intervention Name(s)
Pedometer
Intervention Description
Attend 3 monthly UTMB Breast Cancer Support Group Sessions Monitor daily, weekly, and monthly steps using a pedometer (Digi-walker CW-700/701) Feedback on physical activity and physical function
Primary Outcome Measure Information:
Title
Change in physical activity steps per day as measured by an Actigraph monitor
Description
Change in steps per day between 14 weeks and baseline as measured by an Actigraph monitor
Time Frame
Change in steps per day from baseline to 14 weeks
Title
Change in physical activity minutes as measured by an Actigraph monitor
Description
Change in physical activity minutes between 14 weeks and baseline as measured by an Actigraph monitor
Time Frame
Change in physical activity minutes from baseline to 14 weeks
Secondary Outcome Measure Information:
Title
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
Description
The SPPB consists of six components: repeated chair sit and stands, balance test, semi-tandem stand, tandem stand, side-by-side stand, and eight feet walk
Time Frame
Change in physical function from baseline and 14 weeks
Title
Change in dietary pattern as measured by the Dietary Screener Questionnaire
Description
Change in dietary pattern from baseline and 14 weeks] [Safety Issue: No] The Dietary Screener Questionnaire used in the National Health and Nutrition Examination Survey 2009-10. The screener captures frequency of fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days
Time Frame
Change in dietary pattern from baseline and 14 weeks
Title
Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure
Description
Changes in physical, social, emotional, functional, and additional well-being between 14 weeks and baseline as measured by FACT-B
Time Frame
Change in quality of life from baseline and 14 weeks
Title
Change in hand grip strength as measured by hand dynamometer
Description
Hand dynamometer estimates the muscle strength generated from flexor muscles of the hand and the forearm
Time Frame
Change in hand grip strength from baseline to 14 weeks
Other Pre-specified Outcome Measures:
Title
Change in weight
Description
Change in body weight between 14 weeks and baseline as measured by a weight scale in the clinic
Time Frame
Change in weight from baseline to 14 weeks
Title
Change in waist circumference
Description
Change in waist circumference between 14 weeks and baseline as measured by Seca-203
Time Frame
Change in waist circumference from baseline to 14 weeks
Title
Change in physical activity minutes, measured by the Community Healthy Activities Model Program for Seniors
Description
Self-reported physical activity questionnaire
Time Frame
Change in physical activity minutes from baseline to 14 weeks
Title
Change in physical function, measured by PROMIS measure specific to cancer survivors
Description
Changes in overall self-reported physical functions between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Physical Function
Time Frame
Change in physical function from baseline to 14 weeks
Title
Change in fatigue, measured by PROMIS measure specific to cancer survivors
Description
Changes in overall self-reported fatigue level between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Fatigue
Time Frame
Change in fatigue from baseline to 14 weeks
Title
Change in exercise motivation, measured by autonomous motivation specific to physical activity
Description
Behavioral regulation in Exercise Questionnaire-2 will be used
Time Frame
Change in motivation from baseline to 14 weeks
Title
Change in psychological feelings, measured by Psychological Need Satisfaction in Exercise Scale
Description
Sub-scales included perceived competence, perceived autonomy, and perceived relatedness
Time Frame
Change in psychological feelings from baseline to 14 weeks
Title
Change in self-regulation, measured by Rovinak et al. scale
Description
Sub-scales include exercise goals and exercise plans
Time Frame
Change in self-regulation from baseline to 14 weeks
Title
Feasibility-Adherence
Description
Adherence will be measured by number of participants who completed at least 80% of the program activities.
Time Frame
14 weeks
Title
Feasibility-Attrition
Description
Attrition will be measured by percentage of people who dropped out of the intervention program.
Time Frame
14 weeks
Title
Feasibility-Technological Issues
Description
Technological issues will be measured by counting number of occurrence
Time Frame
14 weeks
Title
Feasibility-Adverse Events
Description
Adverse events will be measured by counting number of occurrence
Time Frame
14 weeks
Title
Acceptability
Description
Participant acceptability and satisfaction will be assessed by a questionnaire with 5-point scale responses
Time Frame
14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide informed consent Diagnosed with primary female breast cancer within 0 to 6 months period of time English-speaking between the ages of 18 and 70 Able to read and write in English Obtained approval from oncologists for the participant to be involved in the physical activity based support group Able to travel to the UTMB Breast Health Center Able to move arms and legs as well as ambulate Able to see TV screen from a distance of 2 to 4 feet Exclusion Criteria: Being pregnant Dementia Currently engage in ≥150 minutes of planned moderate physical activity per week for the prior week Are involved in another physical activity intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Swartz, PhD, MPH
Organizational Affiliation
The University of Texas Medical Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35994321
Citation
Swartz MC, Lewis ZH, Deer RR, Stahl AL, Swartz MD, Christopherson U, Basen-Engquist K, Wells SJ, Silva HC, Lyons EJ. Feasibility and Acceptability of an Active Video Game-Based Physical Activity Support Group (Pink Warrior) for Survivors of Breast Cancer: Randomized Controlled Pilot Trial. JMIR Cancer. 2022 Aug 22;8(3):e36889. doi: 10.2196/36889.
Results Reference
derived

Learn more about this trial

Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

We'll reach out to this number within 24 hrs