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Pink Warrior—Support Group Toolkit for Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02750241
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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-based intervention Behavioral: Pedometer Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Pink Warrior—Support Group Toolkit for Breast Cancer Survivors
Study Start Date : April 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Active video game-based intervention
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.
Behavioral: Active video game-based intervention
  • 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

Active Comparator: Pedometer
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.
Behavioral: Pedometer
  • 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 Measures :
  1. Change in physical activity steps per day as measured by an Actigraph monitor [ Time Frame: Change in steps per day from baseline to 14 weeks ]
    Change in steps per day between 14 weeks and baseline as measured by an Actigraph monitor

  2. Change in physical activity minutes as measured by an Actigraph monitor [ Time Frame: Change in physical activity minutes from baseline to 14 weeks ]
    Change in physical activity minutes between 14 weeks and baseline as measured by an Actigraph monitor


Secondary Outcome Measures :
  1. Change in physical function as measured by the Short Physical Performance Battery (SPPB) [ Time Frame: Change in physical function from baseline and 14 weeks ]
    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

  2. Change in dietary pattern as measured by the Dietary Screener Questionnaire [ Time Frame: Change in dietary pattern from baseline and 14 weeks ]
    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

  3. Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure [ Time Frame: Change in quality of life from baseline and 14 weeks ]
    Changes in physical, social, emotional, functional, and additional well-being between 14 weeks and baseline as measured by FACT-B

  4. Change in hand grip strength as measured by hand dynamometer [ Time Frame: Change in hand grip strength from baseline to 14 weeks ]
    Hand dynamometer estimates the muscle strength generated from flexor muscles of the hand and the forearm


Other Outcome Measures:
  1. Change in weight [ Time Frame: Change in weight from baseline to 14 weeks ]
    Change in body weight between 14 weeks and baseline as measured by a weight scale in the clinic

  2. Change in waist circumference [ Time Frame: Change in waist circumference from baseline to 14 weeks ]
    Change in waist circumference between 14 weeks and baseline as measured by Seca-203

  3. Change in physical activity minutes, measured by the Community Healthy Activities Model Program for Seniors [ Time Frame: Change in physical activity minutes from baseline to 14 weeks ]
    Self-reported physical activity questionnaire

  4. Change in physical function, measured by PROMIS measure specific to cancer survivors [ Time Frame: Change in physical function from baseline to 14 weeks ]
    Changes in overall self-reported physical functions between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Physical Function

  5. Change in fatigue, measured by PROMIS measure specific to cancer survivors [ Time Frame: Change in fatigue from baseline to 14 weeks ]
    Changes in overall self-reported fatigue level between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Fatigue

  6. Change in exercise motivation, measured by autonomous motivation specific to physical activity [ Time Frame: Change in motivation from baseline to 14 weeks ]
    Behavioral regulation in Exercise Questionnaire-2 will be used

  7. Change in psychological feelings, measured by Psychological Need Satisfaction in Exercise Scale [ Time Frame: Change in psychological feelings from baseline to 14 weeks ]
    Sub-scales included perceived competence, perceived autonomy, and perceived relatedness

  8. Change in self-regulation, measured by Rovinak et al. scale [ Time Frame: Change in self-regulation from baseline to 14 weeks ]
    Sub-scales include exercise goals and exercise plans

  9. Feasibility-Adherence [ Time Frame: 14 weeks ]
    Adherence will be measured by number of participants who completed at least 80% of the program activities.

  10. Feasibility-Attrition [ Time Frame: 14 weeks ]
    Attrition will be measured by percentage of people who dropped out of the intervention program.

  11. Feasibility-Technological Issues [ Time Frame: 14 weeks ]
    Technological issues will be measured by counting number of occurrence

  12. Feasibility-Adverse Events [ Time Frame: 14 weeks ]
    Adverse events will be measured by counting number of occurrence

  13. Acceptability [ Time Frame: 14 weeks ]
    Participant acceptability and satisfaction will be assessed by a questionnaire with 5-point scale responses



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750241


Contacts
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Contact: Eloisa Martinez, BS 409-266-9643 esmartin@utmb.edu
Contact: Maria Swartz, PhD, MPH 409-772-2576 mcswartz@utmb.edu

Locations
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United States, Texas
The University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77550
Contact: Eloisa Martinez, BS    409-266-9643    esmartin@utmb.edu   
Contact: Maria Swartz, PhD, MPH    409-772-2576    mcswartz@utmb.edu   
Principal Investigator: Maria Swartz, PhD, MPH         
Sub-Investigator: Elizabeth Lyons, PhD, MPH         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Maria Swartz, PhD, MPH The University of Texas Medical Branch

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02750241     History of Changes
Other Study ID Numbers: 16-0040
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The University of Texas Medical Branch, Galveston:
active video game
mHealth
cancer survivor
women's health
breast cancer
physical activity
support group
survivorship

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases