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Completed

NCT Number: NCT02750241

Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Physical Activity Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active video game-based intervention

Behavioral
  • 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

pedometer

Behavioral
  • 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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2016
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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