Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

NCT02750241 | Completed

• 1 other identifier: 16-0040
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Physical Activity

Keywords

active video game; mHealth; cancer survivor; women's health; breast cancer; physical activity; support group; survivorship

Outcome Measures

Primary Outcomes (2)

• 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 steps per day from baseline to 14 weeks

• 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

  Change in physical activity minutes from baseline to 14 weeks

Secondary Outcomes (4)

• Change in physical function as measured by the Short Physical Performance Battery (SPPB)

  Change in physical function from baseline and 14 weeks

• Change in dietary pattern as measured by the Dietary Screener Questionnaire

  Change in dietary pattern from baseline and 14 weeks

• Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure

  Change in quality of life from baseline and 14 weeks

• Change in hand grip strength as measured by hand dynamometer

  Change in hand grip strength from baseline to 14 weeks

Other Outcomes (13)

• Change in weight

  Change in weight from baseline to 14 weeks

• Change in waist circumference

  Change in waist circumference from baseline to 14 weeks

• Change in physical activity minutes, measured by the Community Healthy Activities Model Program for Seniors

  Change in physical activity minutes from baseline to 14 weeks

Study Arms (2)

Active video game-based intervention

EXPERIMENTAL

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

Pedometer

ACTIVE COMPARATOR

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

Interventions

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

Active video game-based intervention

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

Pedometer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (1)

• 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.

  PMID: 35994321 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Maria Swartz, PhD, MPH

  The University of Texas Medical Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 25, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)