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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Game intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline to 6 months |
| Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 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 | baseline to 6 months |
| Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Lyons, PhD, MPH | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch | Galveston | Texas | 77550 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26960972 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Game Intervention | 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) Game intervention: 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. |
| FG001 | Standard Intervention | 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) Standard intervention: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 6 Months |
| |||||||||||||
| 6 Months to 12 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Game Intervention | 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) Game intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | minutes per day | baseline and 6 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Game Intervention | 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) Game intervention: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Systematic Assessment | Gastroenteritis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Injury, poisoning and procedural complications | Systematic Assessment |
Please interpret numerical outcomes with caution due to large amounts of drop out and low adherence in this pilot trial. All pre-specified PROMIS outcomes that were collected are provided, but note that these measures in particular faced a large amount of missing data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eloisa Martinez | The University of Texas Medical Branch | 409-266-9643 | esmartin@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 | Jun 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| D033262 | Narration |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Standard intervention | Behavioral | 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. |
|
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. |
| baseline to 6 months |
| Change in Weight From Baseline to 6 Months | We will measure weight using a calibrated scale | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | baseline to 6 Months |
We will use the Senior Fitness Test to measure physical function, with a higher number indicating greater function |
| baseline to 6 months |
| Change in Sleep From 6 Months to 1 Year | We will use a computerized PROMIS measure specific to cancer survivors | baseline to 6 months |
| Change in Weight From 6 Months to 1 Year | Weight will be measured using a calibrated scale | baseline to 6 months |
| Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols | We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.) | 1 year |
| Number of Participants Who Report Adverse Events | We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed. | 1 year |
| Change in Anxiety From Baseline to 6 Months | We will use a computerized PROMIS measure to investigate anxiety (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Anxiety). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less anxiety) than the population. | baseline to 6 months |
| Change in Depression From 6 Months to 1 Year | We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression) | baseline to 6 months |
| Change in Fatigue From Baseline to 6 Months | We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 Fatigue). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less fatigued) than the population. | baseline to 6 months |
| Change in Quality of Life From 6 Months to 1 Year | We will use the Functional Assessment of Cancer Therapy - Breast measure | baseline to 6 months |
| Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity | Behavioral Regulation in Exercise Questionnaire-2 will be used, specifically subscales for autonomous motivation (intrinsic, integrated, identified regulation). We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation. | baseline to 6 months |
| Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps | Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire | baseline to 6 months |
| Play Experience, Measured Using the Play Experience Questionnaire | Participants will self-report their perceptions of the playfulness of the intervention apps | Measured at 3 months |
| Change in Exercise Identity From Baseline to 6 Months | We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity | baseline to 6 months |
| Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale | We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline | Measured at 3 months |
| Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale | We will measure the extent to which participants in the narrative group felt like they identified with their game character | Measured at 3 months |
| Change in Depression From Baseline to 6 Months | We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less depressed) than the population. | baseline to 6 months |
| Change in Fatigue From 6 Months to 1 Year | We will use a computerized PROMIS measure specific to cancer patients/survivors | baseline to 6 months |
| Change in Sleep From Baseline to 6 Months | We will use a computerized PROMIS measure (Patient Reported Outcomes Measurement Information System PROMIS Bank v1.0 - Sleep-Related Impairment). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower than the population (more/less impairment). | baseline to 6 months |
| Maintenance of Physical Activity From 6 Months to 1 Year | Minutes of moderate-vigorous physical activity measured over a 7 day period | baseline to 6 months |
| NOT COMPLETED |
|
| BG001 | Standard Intervention | 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) Standard intervention: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time since diagnosis | Mean | Standard Deviation | years |
|
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)
Standard intervention: 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.
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | feet | baseline to 6 months |
|
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| Secondary | 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. | Posted | Mean | Standard Error | number of chair stands | baseline to 6 months |
|
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| Secondary | Change in Weight From Baseline to 6 Months | We will measure weight using a calibrated scale | Posted | Mean | Standard Error | pounds | baseline to 6 months |
|
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | baseline to 6 months |
|
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | baseline to 6 months |
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | baseline to 6 months |
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| Secondary | 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 | Posted | Mean | Standard Error | units on a scale | baseline to 6 Months |
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| Secondary | 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 | Posted | Mean | Standard Error | units on a scale | baseline to 6 Months |
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| Secondary | 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 | Posted | Mean | Standard Error | units on a scale | baseline to 6 Months |
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | baseline to 6 Months |
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | baseline to 6 Months |
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| Secondary | 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. | Posted | Mean | Standard Error | number of arm curls | baseline to 6 Months |
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| Secondary | 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. | Posted | Mean | Standard Error | inches | baseline to 6 Months |
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| Secondary | 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. | Posted | Mean | Standard Error | inches | baseline to 6 Months |
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| Secondary | 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. | Posted | Mean | Standard Error | seconds | baseline to 6 Months |
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| Other Pre-specified | Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 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 | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test | We will use the Senior Fitness Test to measure physical function, with a higher number indicating greater function | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Change in Sleep From 6 Months to 1 Year | We will use a computerized PROMIS measure specific to cancer survivors | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Change in Weight From 6 Months to 1 Year | Weight will be measured using a calibrated scale | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols | We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.) | Not Posted | 1 year | Participants |
| Other Pre-specified | Number of Participants Who Report Adverse Events | We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed. | Not Posted | 1 year | Participants |
| Other Pre-specified | Change in Anxiety From Baseline to 6 Months | We will use a computerized PROMIS measure to investigate anxiety (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Anxiety). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less anxiety) than the population. | Posted | Mean | Standard Error | t-score | baseline to 6 months |
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| Other Pre-specified | Change in Depression From 6 Months to 1 Year | We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression) | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Change in Fatigue From Baseline to 6 Months | We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 Fatigue). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less fatigued) than the population. | Posted | Mean | Standard Error | t-score | baseline to 6 months |
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| Other Pre-specified | Change in Quality of Life From 6 Months to 1 Year | We will use the Functional Assessment of Cancer Therapy - Breast measure | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity | Behavioral Regulation in Exercise Questionnaire-2 will be used, specifically subscales for autonomous motivation (intrinsic, integrated, identified regulation). We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation. | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps | Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Play Experience, Measured Using the Play Experience Questionnaire | Participants will self-report their perceptions of the playfulness of the intervention apps | Not Posted | Measured at 3 months | Participants |
| Other Pre-specified | Change in Exercise Identity From Baseline to 6 Months | We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale | We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline | Not Posted | Measured at 3 months | Participants |
| Other Pre-specified | Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale | We will measure the extent to which participants in the narrative group felt like they identified with their game character | Not Posted | Measured at 3 months | Participants |
| Other Pre-specified | Change in Depression From Baseline to 6 Months | We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less depressed) than the population. | Posted | Mean | Standard Error | t-score | baseline to 6 months |
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| Other Pre-specified | Change in Fatigue From 6 Months to 1 Year | We will use a computerized PROMIS measure specific to cancer patients/survivors | Not Posted | baseline to 6 months | Participants |
| Other Pre-specified | Change in Sleep From Baseline to 6 Months | We will use a computerized PROMIS measure (Patient Reported Outcomes Measurement Information System PROMIS Bank v1.0 - Sleep-Related Impairment). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower than the population (more/less impairment). | Posted | Mean | Standard Error | t-score | baseline to 6 months |
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| Other Pre-specified | Maintenance of Physical Activity From 6 Months to 1 Year | Minutes of moderate-vigorous physical activity measured over a 7 day period | Not Posted | baseline to 6 months | Participants |
| 0 |
| 45 |
| 1 |
| 45 |
| 3 |
| 45 |
| EG001 | Standard Intervention | 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) Standard intervention: 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. | 0 | 45 | 2 | 45 | 2 | 45 |
| Hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Breast reconstruction surgery |
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| Hospitalization | Cardiac disorders | Systematic Assessment | Chest pain |
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| Broken toe | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Shingles | Infections and infestations | Systematic Assessment |
|
| Achilles tendon tear | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003142 | Communication |
| D001519 | Behavior |