Breast Cancer, Obesity
Conditions
Keywords
video game, narrative, story, survivorship, cancer survivor, mhealth, physical activity, women, women's health
Brief 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.
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.
Interventions
BEHAVIORALGame 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.
BEHAVIORALStandard 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.
Sponsors
American Cancer Society, Inc.
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 45 and 75 years old 2. Report a breast cancer diagnosis no more than 10 years prior to enrollment 3. Cessation of menses for 12 months or more 4. Able to read and understand English 5. Able to read words in standard applications on a mobile device 3-4 large 6. Able to walk for exercise 7. Able to find transportation to the study location 8. Willing to use a mobile device provided by the study to participate (or to use one of their own) 9. Willing to be randomized to either group
Exclusion criteria
1. Currently pregnant or nursing 2. Surgery in the past six months 3. Chemotherapy or radiation treatment in the past six months 4. Evidence of disease recurrence 5. Participant is active (90 minutes of moderate-vigorous intensity activity per week or more) 6. BMI is under 25 kg/m2 or over 35 kg/m2 7. 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 8. Participant reports hospitalization within the past year due to psychiatric problem(s) 9. Report current symptoms of alcohol or substance dependence 10. Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period 11. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months 12. Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.) 13. Clinical judgment concerning safety 14. Lost more than 5% body weight in the previous 6 months 15. Currently participating in a physical activity or weight loss program 16. Current smoker 17. Participant already uses an electronic activity monitor (we will ask them to stop) 18. Another member of the household is a participant or staff member on this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Minutes Per Day of Physical Activity | baseline and 6 months | Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test | baseline to 6 months | We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course |
| Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure | baseline to 6 months | 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. |
| Change in Weight From Baseline to 6 Months | baseline to 6 months | We will measure weight using a calibrated scale |
| Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure | baseline to 6 months | 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. |
| Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity | baseline to 6 months | 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. |
| 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 | baseline to 6 months | 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. |
| 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 | baseline to 6 Months | 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 |
| 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 | baseline to 6 Months | 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 |
| Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity | baseline to 6 Months | 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. |
| Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity | baseline to 6 Months | 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. |
| Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure | baseline to 6 Months | 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. |
| Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure | baseline to 6 Months | 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. |
| Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure | baseline to 6 Months | 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. |
| Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test | baseline to 6 Months | 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. |
| 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 | baseline to 6 Months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression From Baseline to 6 Months | 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. |
| Change in Fatigue From 6 Months to 1 Year | baseline to 6 months | We will use a computerized PROMIS measure specific to cancer patients/survivors |
| Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 6 Minute Walk Test | baseline to 6 months | We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course |
| Maintenance of Physical Activity From 6 Months to 1 Year | baseline to 6 months | Minutes of moderate-vigorous physical activity measured over a 7 day period |
| Change in Sleep From Baseline to 6 Months | 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). |
| Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test | baseline to 6 months | We will use the Senior Fitness Test to measure physical function, with a higher number indicating greater function |
| Change in Sleep From 6 Months to 1 Year | baseline to 6 months | We will use a computerized PROMIS measure specific to cancer survivors |
| Change in Weight From 6 Months to 1 Year | baseline to 6 months | Weight will be measured using a calibrated scale |
| Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols | 1 year | We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.) |
| Number of Participants Who Report Adverse Events | 1 year | 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. |
| Change in Anxiety From Baseline to 6 Months | 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. |
| Change in Depression From 6 Months to 1 Year | 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) |
| Change in Fatigue From Baseline to 6 Months | 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. |
| Change in Quality of Life From 6 Months to 1 Year | baseline to 6 months | We will use the Functional Assessment of Cancer Therapy - Breast measure |
| Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity | baseline to 6 months | 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. |
| Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps | baseline to 6 months | Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire |
| Play Experience, Measured Using the Play Experience Questionnaire | Measured at 3 months | Participants will self-report their perceptions of the playfulness of the intervention apps |
| Change in Exercise Identity From Baseline to 6 Months | baseline to 6 months | We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity |
| Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale | Measured at 3 months | We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline |
| Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale | Measured at 3 months | We will measure the extent to which participants in the narrative group felt like they identified with their game character |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Game Intervention | Standard Intervention | Total |
|---|---|---|---|
| Age, Continuous | 62.48 years STANDARD_DEVIATION 6.78 | 59.92 years STANDARD_DEVIATION 7.68 | 61.22 years STANDARD_DEVIATION 7.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 40 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 37 Participants | 33 Participants | 70 Participants |
| Sex: Female, Male Female | 45 Participants | 45 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time since diagnosis | 5.55 years STANDARD_DEVIATION 6.43 | 6.84 years STANDARD_DEVIATION 5.29 | 6.19 years STANDARD_DEVIATION 5.89 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 3 / 45 | 2 / 45 |
| serious Total, serious adverse events | 1 / 45 | 2 / 45 |
Outcome results
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.
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Minutes Per Day of Physical Activity | 20.87 minutes per day | Standard Error 3.29 |
| Standard Intervention | Change in Minutes Per Day of Physical Activity | 15.82 minutes per day | Standard Error 3.54 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.35ANCOVA
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
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | 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 | -0.03 units on a scale | Standard Error 1.16 |
| Standard Intervention | 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 | -.96 units on a scale | Standard Error 1.34 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.57ANCOVA
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
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | 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 | -1.76 units on a scale | Standard Error 1.16 |
| Standard Intervention | 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 | -.27 units on a scale | Standard Error 0.95 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.33ANCOVA
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
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | 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 | .72 units on a scale | Standard Error 1.14 |
| Standard Intervention | 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 | .6 units on a scale | Standard Error 0.87 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.94ANCOVA
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.
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity | .01 units on a scale | Standard Error 0.19 |
| Standard Intervention | Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity | .30 units on a scale | Standard Error 0.21 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.3ANCOVA
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.
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity | .32 units on a scale | Standard Error 0.27 |
| Standard Intervention | Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity | .53 units on a scale | Standard Error 0.18 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.44ANCOVA
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.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity | .11 units on a scale | Standard Error 0.23 |
| Standard Intervention | Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity | .62 units on a scale | Standard Error 0.22 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.055ANCOVA
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
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test | -44.35 feet | Standard Error 106.92 |
| Standard Intervention | Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test | 71.74 feet | Standard Error 88.64 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.22ANCOVA
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.
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test | .68 seconds | Standard Error 0.85 |
| Standard Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test | .26 seconds | Standard Error 0.85 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.72ANCOVA
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.
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure | .39 number of arm curls | Standard Error 1.34 |
| Standard Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure | 1.04 number of arm curls | Standard Error 0.83 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.62ANCOVA
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.
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure | 1.32 inches | Standard Error 1.98 |
| Standard Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure | -.57 inches | Standard Error 0.91 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.41ANCOVA
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.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure | .33 number of chair stands | Standard Error 1.35 |
| Standard Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure | .4 number of chair stands | Standard Error 1.02 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.97ANCOVA
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.
Time frame: baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure | -.05 inches | Standard Error 0.73 |
| Standard Intervention | Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure | .29 inches | Standard Error 0.63 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.7ANCOVA
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.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure | -1.11 units on a scale | Standard Error 0.93 |
| Standard Intervention | Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure | -1.39 units on a scale | Standard Error 0.88 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.83ANCOVA
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.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | 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 | -.74 units on a scale | Standard Error 1.27 |
| Standard Intervention | 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 | -1.53 units on a scale | Standard Error 1.11 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.71ANCOVA
Secondary
Change in Weight From Baseline to 6 Months
We will measure weight using a calibrated scale
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Weight From Baseline to 6 Months | -.14 pounds | Standard Error 4.37 |
| Standard Intervention | Change in Weight From Baseline to 6 Months | -.04 pounds | Standard Error 2.94 |
Comparison: All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.p-value: 0.98ANCOVA
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
Time frame: baseline to 6 months
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.)
Time frame: 1 year
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.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Anxiety From Baseline to 6 Months | 51.34 t-score | Standard Error 0.9 |
| Standard Intervention | Change in Anxiety From Baseline to 6 Months | 49.09 t-score | Standard Error 0.9 |
p-value: 0.084ANCOVA
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)
Time frame: baseline to 6 months
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.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Depression From Baseline to 6 Months | 49.32 t-score | Standard Error 0.77 |
| Standard Intervention | Change in Depression From Baseline to 6 Months | 48.50 t-score | Standard Error 0.77 |
p-value: 0.461ANCOVA
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
Time frame: baseline to 6 months
Other Pre-specified
Change in Fatigue From 6 Months to 1 Year
We will use a computerized PROMIS measure specific to cancer patients/survivors
Time frame: baseline to 6 months
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.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Fatigue From Baseline to 6 Months | 50.96 t-score | Standard Error 0.75 |
| Standard Intervention | Change in Fatigue From Baseline to 6 Months | 50.37 t-score | Standard Error 0.75 |
p-value: 0.58ANCOVA
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.
Time frame: baseline to 6 months
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
Time frame: baseline to 6 months
Other Pre-specified
Change in Sleep From 6 Months to 1 Year
We will use a computerized PROMIS measure specific to cancer survivors
Time frame: baseline to 6 months
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).
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Sleep From Baseline to 6 Months | 52.35 t-score | Standard Error 0.48 |
| Standard Intervention | Change in Sleep From Baseline to 6 Months | 52.30 t-score | Standard Error 0.48 |
p-value: 0.934ANCOVA
Other Pre-specified
Change in Weight From 6 Months to 1 Year
Weight will be measured using a calibrated scale
Time frame: baseline to 6 months
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
Time frame: Measured at 3 months
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
Time frame: baseline to 6 months
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
Time frame: baseline to 6 months
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
Time frame: baseline to 6 months
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
Time frame: Measured at 3 months
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.
Time frame: 1 year
Other Pre-specified
Play Experience, Measured Using the Play Experience Questionnaire
Participants will self-report their perceptions of the playfulness of the intervention apps
Time frame: Measured at 3 months