Breast CancerNCT02750241
Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
A study testing Active video game-based intervention and Pedometer in people with Breast Cancer and Physical Activity, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Physical Activity
- What is being tested?
- Active video game-based intervention and Pedometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77550
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Physical Activity
- Being tested
- Active video game-based intervention, Pedometer
- Keywords
- active video game, mHealth, cancer survivor, women's health, breast cancer, physical activity, support group, survivorship
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active video game-based interventionBehavioural
- 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
PedometerBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
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
Measured: 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] [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
Measured: 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
Changes in physical, social, emotional, functional, and additional well-being between 14 weeks and baseline as measured by FACT-B
Measured: Change in quality of life from baseline and 14 weeks
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
Measured: Change in hand grip strength from baseline to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Swartz, PhD, MPH, Principal investigator, The University of Texas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750241
- Sponsor's protocol ID
- 16-0040
- Status last verified
- Dec 2019
- First submitted
- 18 Apr 2016
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35994321
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02750241
- Acronym / sponsor ID
- 16-0040
- Conditions
- Breast Cancer, Physical Activity
- Keywords
- active video game, mHealth, cancer survivor, women's health, breast cancer, physical activity, support group, survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active video game-based intervention | Experimental | Behavioral: Active video game-based interventionThis 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. |
| Pedometer | Active comparator | Behavioral: PedometerThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Active video game-based intervention |
| 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 | Behavioural | Pedometer |
Primary outcome
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
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
4 secondary outcomes
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
Time frame: Change in physical function from baseline and 14 weeks
Change in dietary pattern as measured by the Dietary Screener Questionnaire
Time frame: 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
Time frame: Change in quality of life from baseline and 14 weeks
Change in hand grip strength as measured by hand dynamometer
Time frame: Change in hand grip strength from baseline to 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 35994321Swartz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Swartz, PhD, MPH principal investigator
The University of Texas Medical Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active video game-based intervention and Pedometer in people with Breast Cancer and Physical Activity, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.