Narrative Visualization for Breast Cancer Survivors' Physical Activity

Study Overview
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Brief Summary
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This study tests the feasibility and acceptability of a physical activity intervention that combines use of a wearable activity monitor with a scrapbook. Half of the participants will receive this enhanced intervention, while the other half will receive a wearable activity monitor with a standard step log.

Detailed Description
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Women breast cancer survivors could benefit from increased physical activity but are in need of greater motivation to be active. Interventions that use wearable activity monitors and mobile apps have shown promise in the short-term, but use drops off over time. Reports have suggested that users find the step data provided to be unclear and not very personally meaningful. The ultimate purpose of this line of research is to test whether enhanced motivational feedback, using scrapbooks, can increase motivation for activity. The scrapbooks will target integrated regulation, which is a type of motivation related to personal identity and values. Participants who receive this intervention will draw their step graph, add photographs and stickers an explanations to the graph, and answer reflection questions daily. Before testing the effects of this intervention on physical activity, the investigators must first ensure that the materials and procedures are feasible and acceptable. This small pilot study will allow the research team to iteratively test scrapbook materials and improve upon them for use in future studies. The investigators will compare an intervention using the enhanced materials to an intervention using only the wearable device, app, and a standard step log without scrapbook or reflection components. In addition to the primary outcome of feasibility (use of the scrapbook), the investigators will also explore the effects of the intervention on steps, motivational and values-related outcomes, and various aspects of feasibility and acceptability.

Official Title
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Narrative Visualization for Breast Cancer Survivors' Physical Activity

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Narrative visualization
* Behavioral: Standard self-regulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 55 and 79 years Female Self-reported diagnosis of breast cancer BMI between 18 and 40 kg/m2 Willingness to be randomized to any condition Participant is able to walk for exercise Able to read and understand English Daily access to a smartphone or similar device compatible with Garmin app PAR-Q+ indicates that physical activity would be safe (with note from physician required if any heart-related questions are endorsed) Exclusion Criteria: Participant is active (150 minutes or more activity per week) Major health interventions (surgery, radiation, chemo) within the past 6 months Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months History of orthopedic complications that would prevent optimal participation No active recurrence of cancer Self-reported smoker Reports psychological issues that would interfere with study completion (dementia, schizophrenia) Reports hospitalization within the past year due to psychiatric problem(s) Plans to be out of town for more than 2 weeks at a time during study period Clinical judgement concerning safety Currently participating in an organized commercial or research exercise program Another member of the household is a participant or staff member on this trial Current use of a wearable activity monitor

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrative visualization<br>Wearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content) | Behavioral: Narrative visualization<br>* Participants use narrative visualization procedures to connect their step data to important events or feelings that occurred at the same time, then reflect on their behavior<br>|
| Active Comparator: Standard self-regulation<br>Wearable activity monitor, app, and standard workbook materials (markers, a workbook with a calendar log to keep track of steps over time) | Behavioral: Standard self-regulation<br>* Participants self-monitor steps using a wearable device, app, and a hand-written step log<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Daily Workbook Entries Completed | Percentage of daily workbook entries completed out of the total possible number, measured by photography of intervention materials at 12 week assessment and then assessment of each page. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity as Measured by Steps Per Day During Intervention Period | Mean of daily steps taken from accelerometers worn for 7 days | Change from 0 to 12 weeks | 
| Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period | Mean of steps per day taken from accelerometers worn for 7 days | Change from 12 to 24 weeks | 
| Intrinsic Regulation | Self-reported intrinsic regulation on a scale from 0 (least motivated) to 4 (most motivated) using the Behavioral Regulation in Exercise Questionnaire - 3. Reported here are results from the intrinsic regulation subscale. Higher results on the scale indicate greater intrinsic regulation. | Change from 0 to 12 weeks | 
| Integrated Regulation | Self-reported integrated regulation on a scale from 0 (least motivated) to 4 (most motivated) using the Behavioral Regulation in Exercise Questionnaire - 3. Here, results from the integrated regulation subscale are reported. Higher numbers on the scale indicate greater integrated regulation. | Change from 0 to 12 weeks | 
| Basic Psychological Needs: Autonomy | Self-reported fulfillment of basic psychological needs on a scale from 1 (least fulfilled) to 5 (most fulfilled) using the Basic Psychological Needs in Exercise Questionnaire. The three subscales are perceived autonomy, competence, and relatedness. Here, autonomy is reported. A higher score means greater perceived autonomy. | Change from 0 to 12 weeks | 
| Exercise Identity | Self-reported identity as an exerciser on a scale from 1 (strongly disagree) to 7 (strongly agree) as measured by the Exercise Identity Scale. The two subscales are exercise beliefs and exercise role identity. Here, exercise role identity is reported. A higher score means greater exercise role identity. | Change from 0 to 12 weeks | 
| Basic Psychological Needs: Competence | Self-reported fulfillment of basic psychological needs on a scale from 1 (least fulfilled) to 5 (most fulfilled) using the Basic Psychological Needs in Exercise Questionnaire. The three subscales are perceived autonomy, competence, and relatedness. Here, competence is reported. A higher score means greater perceived competence. | 0 to 12 weeks | 
| Basic Psychological Needs: Relatedness | Self-reported fulfillment of basic psychological needs on a scale from 1 (least fulfilled) to 5 (most fulfilled) using the Basic Psychological Needs in Exercise Questionnaire. The three subscales are perceived autonomy, competence, and relatedness. Here, relatedness is reported. A higher score means greater perceived relatedness. | 0 to 12 weeks | 
| Self-reflection | Self-reported self-reflection on a scale from 1 (strongly disagree) to 5 (strongly agree) using the Self-Reflection and Insight Scale. Here, we report changes in the insight subscale, which has 8 items and a range of 5-40. For this scale, higher values indicate greater levels of insight. | Change from 0 to 12 weeks | 
| Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific) | Self-reported quality of life on a scale from 0 (not at all) to 4 (very much) using the Functional Assessment of Cancer Therapy - Breast measure. Reported here is the change in total score for the entire measure (with the total ranging from 0-123). Better quality of life is indicated by a lower score. | Change from 0 to 12 weeks | 
| Importance of Valued Domains | Self-reported importance of family, intimate relationships, friends, work, health, and growth values domains on a scale from 0 (not at all important) to 5 (extremely important) using the Chronic Pain Values Inventory. Reported here is the change in total across all domains, which is an average of the individual items (range: 0-5). A higher score indicates stronger endorsement of importance of the valued domains. | Change from 0 to 12 weeks | 
| Success in Living According to Valued Domains | Self-reported success in living according to values related to family, intimate relations, friends, work, health, and growth on a scale from 0 (not at all successful) to 5 (extremely successful) using the Chronic Pain Values Inventory. Reported here is the change in total across all domains, as an average across items (range: 0-5). A higher score indicates stronger endorsement of success in the valued domains. | Change from 0 to 12 weeks | 
| Engaged Living | Self-reported perception of living in accordance with one's values on a scale from 1 (completely disagree) to 5 (completely agree) using the Engaged Living Scale. The two subscales are valued living and life fulfillment. Reported here is the change in total results for the scale (which ranges from 16-80). Higher scores on this scale indicate higher levels of engaged living. | Change from 0 to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable, mobile app, physical activity, survivorship, narrative, identity