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Completed

NCT Number: NCT02341235

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

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.

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Key information

Conditions

Breast Cancer Behavior Body Weight Breast Diseases Breast Neoplasms Communication Motor Activity Narration Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 45 and 75 years old
  • Report a breast cancer diagnosis no more than 10 years prior to enrollment
  • Cessation of menses for 12 months or more
  • Able to read and understand English
  • Able to read words in standard applications on a mobile device 3-4" large
  • Able to walk for exercise
  • Able to find transportation to the study location
  • Willing to use a mobile device provided by the study to participate (or to use one of their own)
  • Willing to be randomized to either group

Exclusion criteria

  • Currently pregnant or nursing
  • Surgery in the past six months
  • Chemotherapy or radiation treatment in the past six months
  • Evidence of disease recurrence
  • Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)
  • BMI is under 25 kg/m2 or over 35 kg/m2
  • Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless cleared by their physician
  • Participant reports hospitalization within the past year due to psychiatric problem(s)
  • Report current symptoms of alcohol or substance dependence
  • Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
  • Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  • Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.)
  • Clinical judgment concerning safety
  • Lost more than 5% body weight in the previous 6 months
  • Currently participating in a physical activity or weight loss program
  • Current smoker
  • Participant already uses an electronic activity monitor (we will ask them to stop)
  • Another member of the household is a participant or staff member on this trial

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Minutes Per Day of Physical Activity

    Time frame: baseline and 6 months

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

Secondary outcomes

  1. Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test

    Time frame: 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

  2. Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure

    Time frame: baseline to 6 months

    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.

  3. Change in Weight From Baseline to 6 Months

    Time frame: baseline to 6 months

    We will measure weight using a calibrated scale

  4. Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure

    Time frame: baseline to 6 months

    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.

  5. Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity

    Time frame: 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.

  6. Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale

    Time frame: baseline to 6 months

    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.

  7. Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale

    Time frame: baseline to 6 Months

    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

  8. Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale

    Time frame: baseline to 6 Months

    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

  9. Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale

    Time frame: baseline to 6 Months

    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

  10. Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity

    Time frame: 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.

  11. Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity

    Time frame: 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.

  12. Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure

    Time frame: baseline to 6 Months

    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.

  13. Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure

    Time frame: baseline to 6 Months

    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.

  14. Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure

    Time frame: baseline to 6 Months

    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.

  15. Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test

    Time frame: baseline to 6 Months

    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.

Other outcomes

  1. Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 6 Minute Walk Test

    Time frame: 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

  2. Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test

    Time frame: baseline to 6 months

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

  3. Change in Sleep From 6 Months to 1 Year

    Time frame: baseline to 6 months

    We will use a computerized PROMIS measure specific to cancer survivors

  4. Change in Weight From 6 Months to 1 Year

    Time frame: baseline to 6 months

    Weight will be measured using a calibrated scale

  5. Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols

    Time frame: 1 year

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

  6. Number of Participants Who Report Adverse Events

    Time frame: 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.

  7. Change in Anxiety From Baseline to 6 Months

    Time frame: 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.

  8. Change in Depression From 6 Months to 1 Year

    Time frame: 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)

  9. Change in Fatigue From Baseline to 6 Months

    Time frame: 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.

  10. Change in Quality of Life From 6 Months to 1 Year

    Time frame: baseline to 6 months

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

  11. Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity

    Time frame: 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.

  12. Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps

    Time frame: baseline to 6 months

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

  13. Play Experience, Measured Using the Play Experience Questionnaire

    Time frame: Measured at 3 months

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

  14. Change in Exercise Identity From Baseline to 6 Months

    Time frame: baseline to 6 months

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

  15. Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale

    Time frame: Measured at 3 months

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

  16. Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale

    Time frame: Measured at 3 months

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

  17. Change in Depression From Baseline to 6 Months

    Time frame: 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.

  18. Change in Fatigue From 6 Months to 1 Year

    Time frame: baseline to 6 months

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

  19. Change in Sleep From Baseline to 6 Months

    Time frame: 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).

  20. Maintenance of Physical Activity From 6 Months to 1 Year

    Time frame: baseline to 6 months

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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

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

Acronym: SMARTGOAL

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jan 19, 2015
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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