NCT04259905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 8, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

January 30, 2020

Results QC Date

March 27, 2023

Last Update Submit

May 12, 2023

Conditions

Breast CancerPhysical Activity

Keywords

active video gametelemedicinecancer survivorwomen's healthsupport groupsurvivorshipmhealth

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to 14 weeks

Secondary Outcomes (2)

  • Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks

    Baseline to 14 weeks

  • Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks

    Baseline to 14 weeks

Other Outcomes (17)

  • Walking Skills in Daily Life

    Baseline to 14 weeks

  • Hand Grip Strength

    Baseline to 14 weeks

  • Physical Function as Measured by the Senior Fitness Test

    Baseline to 14 weeks

  • +14 more other outcomes

Study Arms (2)

Active video game teleconference support group

EXPERIMENTAL

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.

Behavioral: Active video game teleconference support group

Standard support group + pedometer

ACTIVE COMPARATOR

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.

Behavioral: Standard support group + pedometer

Interventions

Active video game teleconference support groupBEHAVIORAL

12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device

Active video game teleconference support group
Standard support group + pedometerBEHAVIORAL

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

Standard support group + pedometer

Eligibility Criteria

Age55 Years - 79 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide informed consent
  • Diagnosed with primary female breast cancer
  • years to 79
  • Able to speak, read, and write in English
  • Able to travel to UTMB locations and/or MD Anderson Victory Lakes
  • Able to move arms and les as well as ambulate
  • Has a smartphone, tablet or computer and daily access to a reliable internet

You may not qualify if:

  • Pregnancy
  • Diagnosed dementia
  • Currently engage in 150 minutes or more of planned moderate intensity physical activity
  • Currently involved in another physical activity intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Limitations and Caveats

Due to COVID-19 restrictions, we were unable to complete collection of Senior Fitness Test or hand grip measures. These were moved from secondary to other pre-specified outcomes. Other objective measures were collected via videoconference.

Results Point of Contact

Title
Eloisa Martinez
Organization
The University of Texas Medical Branch
esmartin@utmb.edu
409-266-9643

Study Officials

  • Elizabeth J Lyons, PhD, MPH

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

January 30, 2020

First Posted

February 7, 2020

Study Start

May 11, 2020

Primary Completion

January 29, 2022

Study Completion

March 29, 2022

Last Updated

June 8, 2023

Results First Posted

June 8, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)