Trial Outcomes & Findings for Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (NCT NCT02341235)

NCT ID: NCT02341235

Last Updated: 2024-07-31

Results Overview

Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2024-07-31

Participant Flow

Participant milestones

Measure	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.	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.
Baseline to 6 Months STARTED	45	45
Baseline to 6 Months COMPLETED	28	31
Baseline to 6 Months NOT COMPLETED	17	14
6 Months to 12 Months STARTED	28	31
6 Months to 12 Months COMPLETED	22	21
6 Months to 12 Months NOT COMPLETED	6	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-monitoring Activity: a Randomized Trial of Game-oriented Applications

Baseline characteristics by cohort

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.	Total n=90 Participants Total of all reporting groups
Age, Continuous	62.48 years STANDARD_DEVIATION 6.78 • n=5 Participants	59.92 years STANDARD_DEVIATION 7.68 • n=7 Participants	61.22 years STANDARD_DEVIATION 7.31 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Time since diagnosis	5.55 years STANDARD_DEVIATION 6.43 • n=5 Participants	6.84 years STANDARD_DEVIATION 5.29 • n=7 Participants	6.19 years STANDARD_DEVIATION 5.89 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Minutes Per Day of Physical Activity	20.87 minutes per day Standard Error 3.29	15.82 minutes per day Standard Error 3.54

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test	-44.35 feet Standard Error 106.92	71.74 feet Standard Error 88.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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	.4 number of chair stands Standard Error 1.02

SECONDARY outcome

Timeframe: baseline to 6 months

We will measure weight using a calibrated scale

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Weight From Baseline to 6 Months	-.14 pounds Standard Error 4.37	-.04 pounds Standard Error 2.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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 .93	-1.39 units on a scale Standard Error .88

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity	.11 units on a scale Standard Error .23	.62 units on a scale Standard Error .22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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	-1.53 units on a scale Standard Error 1.11

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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	-.27 units on a scale Standard Error .95

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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	.6 units on a scale Standard Error .87

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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	-.96 units on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity	.01 units on a scale Standard Error .19	.30 units on a scale Standard Error .21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity	.32 units on a scale Standard Error .27	.53 units on a scale Standard Error .18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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	1.04 number of arm curls Standard Error .83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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 .73	.29 inches Standard Error .63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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	-.57 inches Standard Error .91

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
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 .85	.26 seconds Standard Error .85

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

We will use the Senior Fitness Test to measure physical function, with a higher number indicating greater function

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

We will use a computerized PROMIS measure specific to cancer survivors

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

Weight will be measured using a calibrated scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Anxiety From Baseline to 6 Months	51.34 t-score Standard Error 0.90	49.09 t-score Standard Error 0.90

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Fatigue From Baseline to 6 Months	50.96 t-score Standard Error 0.75	50.37 t-score Standard Error 0.75

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

We will use the Functional Assessment of Cancer Therapy - Breast measure

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at 3 months

Participants will self-report their perceptions of the playfulness of the intervention apps

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at 3 months

We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at 3 months

We will measure the extent to which participants in the narrative group felt like they identified with their game character

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Depression From Baseline to 6 Months	49.32 t-score Standard Error 0.77	48.50 t-score Standard Error 0.77

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

We will use a computerized PROMIS measure specific to cancer patients/survivors

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Game Intervention n=45 Participants 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.	Standard Intervention n=45 Participants 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.
Change in Sleep From Baseline to 6 Months	52.35 t-score Standard Error 0.48	52.30 t-score Standard Error 0.48

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

Minutes of moderate-vigorous physical activity measured over a 7 day period

Outcome measures

Outcome data not reported

Adverse Events

Game Intervention

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Intervention

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Game Intervention n=45 participants at risk 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.	Standard Intervention n=45 participants at risk 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.
Gastrointestinal disorders Hospitalization	0.00% 0/45 • 1 year	2.2% 1/45 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization	2.2% 1/45 • Number of events 1 • 1 year	0.00% 0/45 • 1 year
Cardiac disorders Hospitalization	0.00% 0/45 • 1 year	2.2% 1/45 • Number of events 1 • 1 year

Other adverse events

Measure	Game Intervention n=45 participants at risk 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.	Standard Intervention n=45 participants at risk 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.
Injury, poisoning and procedural complications Back pain	0.00% 0/45 • 1 year	2.2% 1/45 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Broken toe	2.2% 1/45 • Number of events 1 • 1 year	0.00% 0/45 • 1 year
Injury, poisoning and procedural complications Fall	0.00% 0/45 • 1 year	2.2% 1/45 • Number of events 1 • 1 year
Infections and infestations Shingles	2.2% 1/45 • Number of events 1 • 1 year	0.00% 0/45 • 1 year
Injury, poisoning and procedural complications Achilles tendon tear	2.2% 1/45 • Number of events 1 • 1 year	0.00% 0/45 • 1 year

Additional Information

Eloisa Martinez

The University of Texas Medical Branch

Phone: 409-266-9643

Email: esmartin@utmb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place