Breast CancerSMARTGOALNCT02341235
Self-monitoring Activity: a Randomized Trial of Game-oriented Applications
A study testing Game intervention and Standard intervention in people with Breast Cancer and Obesity, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Obesity
- What is being tested?
- Game intervention and Standard intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 45 and 75 years old
- Report a breast cancer diagnosis no more than 10 years prior to enrollment
- Cessation of menses for 12 months or more
- Able to read and understand English
- Able to read words in standard applications on a mobile device 3-4" large
- Able to walk for exercise
Show all 9Show fewer
- Able to find transportation to the study location
- Willing to use a mobile device provided by the study to participate (or to use one of their own)
- Willing to be randomized to either group
Who cannot join
- Currently pregnant or nursing
- Surgery in the past six months
- Chemotherapy or radiation treatment in the past six months
- Evidence of disease recurrence
- Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)
- BMI is under 25 kg/m2 or over 35 kg/m2
Show all 18Show fewer
- Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless cleared by their physician
- Participant reports hospitalization within the past year due to psychiatric problem(s)
- Report current symptoms of alcohol or substance dependence
- Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.)
- Clinical judgment concerning safety
- Lost more than 5% body weight in the previous 6 months
- Currently participating in a physical activity or weight loss program
- Current smoker
- Participant already uses an electronic activity monitor (we will ask them to stop)
- Another member of the household is a participant or staff member on this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77550
About this study
Official title: Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.
Read the detailed description
Habitual physical activity decreases risk of multiple negative health outcomes, including breast cancer recurrence and mortality. It is also associated with better quality of life and reducing negative effects of cancer and cancer treatment. However, most breast cancer survivors do not engage in sufficient physical activity. Behavior change interventions produce short-term increases in activity but have difficulty motivating sustained active lifestyles over longer periods and are not equally effective in women of different races/ethnicities. The purpose of this study is to test a novel intervention that uses video games and storytelling to increase motivation. Video game mechanics increase enjoyment and feelings of autonomy (control), competence, and relatedness to others. All of these feelings are associated with motivation for activity and, in turn, sustained activity over time. Additionally, narrative storytelling is an effective method of persuading individuals to change their behavior. We propose that play of active video games that include compelling storylines will increase physical activity among a diverse sample of postmenopausal breast cancer survivors.
To test this hypothesis, we will conduct a clinical trial that compares the enhanced intervention (story-based video games) to a standard intervention in 90 sedentary, overweight postmenopausal breast cancer survivors. Participants in the enhanced group will receive a mobile device and accessories with two story-based video game applications installed. The games incorporate behavior change strategies such as self-monitoring and feedback while also using game mechanics and a lengthy storyline to motivate physical activity. Participants in the standard group will receive the same mobile device with an electronic activity monitor and its companion feedback application. Both groups will receive brief weekly telephone counseling. By comparing two groups that both receive typical behavior change intervention components (counseling) and a novel electronic intervention, we will be able to investigate the specific effects of game mechanics and storytelling on motivation and physical activity. We will measure changes in physical activity, fitness, function, and quality of life from the beginning of the study to 6 months. We will also investigate further changes during an additional 6 month follow-up period in which participants keep their intervention tools but do not receive any counseling, to measure maintenance of activity. This project will develop and test a promising, innovative intervention that has the potential to be used on a widespread basis in clinical and community settings.
- Conditions
- Breast Cancer, Obesity
- Being tested
- Game intervention, Standard intervention
- Keywords
- video game, narrative, story, survivorship, cancer survivor, mhealth, physical activity, women, women's health
- Medical subject headings
- Breast Neoplasms, Obesity, Narration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game interventionBehavioural
The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.
Standard interventionBehavioural
The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.
| Study group | Role | What they receive |
|---|---|---|
| Game intervention | Experimental | Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months) Receives: Behavioral: Game intervention |
| Standard intervention | Active comparator | Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months) Receives: Behavioral: Standard intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minutes Per Day of Physical Activity
Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.
Measured: baseline and 6 months
Secondary outcomes (15)
Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test
We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course
Measured: baseline to 6 months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure
We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of chair stands that can be completed within 30 seconds. A higher number indicates better function in this area.
Measured: baseline to 6 months
Change in Weight From Baseline to 6 Months
We will measure weight using a calibrated scale
Measured: baseline to 6 months
Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure
We will use the Functional Assessment of Cancer Therapy - Breast measure's physical subscale. This scale has a range of 0-28 and 7 items measured on a 5 point scale (not at all to very much). A higher score indicates greater physical quality of life.
Measured: baseline to 6 months
Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity
The Behavioral Regulation in Exercise Questionnaire-2 intrinsic regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates higher intrinsic motivation.
Measured: baseline to 6 months
Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale
We will use the Functional Assessment of Cancer Therapy - Breast measure's social/family subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater social/family quality of life.
Measured: baseline to 6 months
Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale
We will use the Functional Assessment of Cancer Therapy - Breast measure's emotional subscale. This scale has a range of 0-24 and 6 items measured on a 5-point scale (not at all to very much). A higher score indicates greater emotional quality of life
Measured: baseline to 6 Months
Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale
We will use the Functional Assessment of Cancer Therapy - Breast measure's functional subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater functional quality of life
Measured: baseline to 6 Months
Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale
We will use the Functional Assessment of Cancer Therapy - Breast measure's breast cancer subscale. This scale has a range of 0-40 and 10 items measured on a 5-point scale (not at all to very much). A higher score indicates greater breast cancer-related quality of life
Measured: baseline to 6 Months
Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity
The Behavioral Regulation in Exercise Questionnaire-2 identified regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation.
Measured: baseline to 6 Months
Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity
We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation.
Measured: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure
We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of arm curls that can be completed within 30 seconds. A higher number indicates better function in this area.
Measured: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure
We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance an individual can reach from their toes when bending forward. A higher number indicates better function in this area.
Measured: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure
We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance between an individual's arms when they reach them behind their back (one higher above the shoulder and one lower). A higher number indicates better function in this area.
Measured: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test
We will use the Senior Fitness Test to measure physical function, specifically in regards to the time in which an individual can sit up, walk 8 feet around a cone, and sit back down. A lower number indicates better function in this area.
Measured: baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Lyons, PhD, MPH, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341235
- Sponsor's protocol ID
- 14-0376
- Acronym
- SMARTGOAL
- Status last verified
- Jul 2024
- First submitted
- 9 Jan 2015
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lyons EJ, Baranowski T, Basen-Engquist KM, Lewis ZH, Swartz MC, Jennings K, Volpi E. Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial. BMC Cancer. 2016 Mar 9;16:202. doi: 10.1186/s12885-016-2244-y.
PubMed 26960972
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
- ClinicalTrials.gov ID
- NCT02341235
- Acronym / sponsor ID
- SMARTGOAL / 14-0376
- Conditions
- Breast Cancer, Obesity
- Keywords
- video game, narrative, story, survivorship, cancer survivor, mhealth, physical activity, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Feb 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.
Detailed description
Habitual physical activity decreases risk of multiple negative health outcomes, including breast cancer recurrence and mortality. It is also associated with better quality of life and reducing negative effects of cancer and cancer treatment. However, most breast cancer survivors do not engage in sufficient physical activity. Behavior change interventions produce short-term increases in activity but have difficulty motivating sustained active lifestyles over longer periods and are not equally effective in women of different races/ethnicities. The purpose of this study is to test a novel intervention that uses video games and storytelling to increase motivation. Video game mechanics increase enjoyment and feelings of autonomy (control), competence, and relatedness to others. All of these feelings are associated with motivation for activity and, in turn, sustained activity over time. Additionally, narrative storytelling is an effective method of persuading individuals to change their behavior. We propose that play of active video games that include compelling storylines will increase physical activity among a diverse sample of postmenopausal breast cancer survivors.
To test this hypothesis, we will conduct a clinical trial that compares the enhanced intervention (story-based video games) to a standard intervention in 90 sedentary, overweight postmenopausal breast cancer survivors. Participants in the enhanced group will receive a mobile device and accessories with two story-based video game applications installed. The games incorporate behavior change strategies such as self-monitoring and feedback while also using game mechanics and a lengthy storyline to motivate physical activity. Participants in the standard group will receive the same mobile device with an electronic activity monitor and its companion feedback application. Both groups will receive brief weekly telephone counseling. By comparing two groups that both receive typical behavior change intervention components (counseling) and a novel electronic intervention, we will be able to investigate the specific effects of game mechanics and storytelling on motivation and physical activity. We will measure changes in physical activity, fitness, function, and quality of life from the beginning of the study to 6 months. We will also investigate further changes during an additional 6 month follow-up period in which participants keep their intervention tools but do not receive any counseling, to measure maintenance of activity. This project will develop and test a promising, innovative intervention that has the potential to be used on a widespread basis in clinical and community settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game intervention | Experimental | Behavioral: Game interventionParticipants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months) |
| Standard intervention | Active comparator | Behavioral: Standard interventionParticipants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 45 and 75 years old
- Report a breast cancer diagnosis no more than 10 years prior to enrollment
- Cessation of menses for 12 months or more
- Able to read and understand English
- Able to read words in standard applications on a mobile device 3-4" large
Key exclusion criteria (18 listed)
- Currently pregnant or nursing
- Surgery in the past six months
- Chemotherapy or radiation treatment in the past six months
- Evidence of disease recurrence
- Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)
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 |
|---|---|---|
| Game interventionThe game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games. | Behavioural | Game intervention |
| Standard interventionThe electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building. | Behavioural | Standard intervention |
Primary outcome
Change in Minutes Per Day of Physical Activity
Time frame: baseline and 6 months
Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.
15 secondary outcomes
Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test
Time frame: baseline to 6 months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure
Time frame: baseline to 6 months
Change in Weight From Baseline to 6 Months
Time frame: baseline to 6 months
Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure
Time frame: baseline to 6 months
Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity
Time frame: baseline to 6 months
Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale
Time frame: baseline to 6 months
Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale
Time frame: baseline to 6 Months
Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale
Time frame: baseline to 6 Months
Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale
Time frame: baseline to 6 Months
Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity
Time frame: baseline to 6 Months
Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity
Time frame: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure
Time frame: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure
Time frame: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure
Time frame: baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test
Time frame: baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26960972Lyons EJ, Baranowski T, Basen-Engquist KM, Lewis ZH, Swartz MC, Jennings K, Volpi E. Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial. BMC Cancer. 2016 Mar 9;16:202. doi: 10.1186/s12885-016-2244-y.
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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.
Elizabeth Lyons, PhD, MPH principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game intervention and Standard intervention in people with Breast Cancer and Obesity, 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 9 inclusion and 18 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 31 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Minutes Per Day of Physical Activity (time frame: baseline and 6 months). 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 NCT02341235, 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 31 Jul 2024.