An interventional study of Narrative visualization and Standard self-regulation in Breast Cancer, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to female participants aged 55 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Other
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Wearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content)
Behavioral: Narrative visualization
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
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
Participants self-monitor steps using a wearable device, app, and a hand-written step log
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.
Time frame: 12 weeks
Physical Activity as Measured by Steps Per Day During Intervention Period
Mean of daily steps taken from accelerometers worn for 7 days
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from 0 to 12 weeks
Receipt of Study Materials
Self-reported percent of study materials received out of total supplied
Time frame: 12 weeks
Usefulness of Study Materials
Self-reported usefulness of study materials, on a scale from 1 (strongly disagree they were useful) to 5 (strongly agree they were useful)
Time frame: 12 weeks
Participant Attrition
Number of participants in each group who are lost to follow-up
Time frame: 24 weeks
Number of Serious Adverse Events
The number of serious adverse events that occur during the intervention (0 - 12 weeks) and follow-up period (12 - 24 weeks)
Time frame: Up to 24 weeks
Days the Activity Monitor Was Worn
The number of days the activity monitor was worn, as assessed via review of the mobile app
Time frame: 12 weeks
Completion of Values Clarification Activity
From photographs taken of the intervention materials at the 12 week assessment, the investigators will assess whether participants in the enhanced intervention group completed their values clarification activity
Time frame: 12 weeks
| Milestone | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Started | 20 | 20 |
| Completed | 18 | 19 |
| Not completed | 2 | 1 |
| Milestone | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Started | 18 | 19 |
| Completed | 18 | 19 |
| Not completed | 0 | 0 |
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.
| percent | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Percentage of Daily Workbook Entries Completed | 44 ± 45 | — |
Mean of daily steps taken from accelerometers worn for 7 days
| steps per day | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Physical Activity as Measured by Steps Per Day During Intervention Period | 936.22 ± 1332.46 | 913.68 ± 1613.03 |
Mean of steps per day taken from accelerometers worn for 7 days
| steps per day | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period | -829.37 ± 1320.50 | -893.73 ± 1191.96 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Intrinsic Regulation | 0.49 ± 1.24 | 0.46 ± 1.03 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Integrated Regulation | 0.39 ± 1.13 | 0.17 ± 1.17 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Basic Psychological Needs: Autonomy | 0.96 ± 1.17 | 0.50 ± 0.79 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Exercise Identity | 0.73 ± 1.42 | 0.48 ± 0.95 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Basic Psychological Needs: Competence | 1.04 ± 1.25 | 0.77 ± 0.83 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Basic Psychological Needs: Relatedness | 0.12 ± 1.36 | 0.41 ± 1.94 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Self-reflection | 0.56 ± 2.38 | 1.63 ± 3.58 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific) | 4.04 ± 8.04 | 8.92 ± 12.13 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Importance of Valued Domains | -0.23 ± 0.38 | 0.15 ± 0.56 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Success in Living According to Valued Domains | 0.37 ± 0.74 | 0.48 ± 0.94 |
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.
| units on a scale | Narrative Visualization | Standard Self-regulation |
|---|---|---|
| Engaged Living | 2.56 ± 6.64 | 3.39 ± 6.99 |
Self-reported percent of study materials received out of total supplied
Results for this outcome have not been posted.
Self-reported usefulness of study materials, on a scale from 1 (strongly disagree they were useful) to 5 (strongly agree they were useful)
Results for this outcome have not been posted.
Number of participants in each group who are lost to follow-up
Results for this outcome have not been posted.
The number of serious adverse events that occur during the intervention (0 - 12 weeks) and follow-up period (12 - 24 weeks)
Results for this outcome have not been posted.
The number of days the activity monitor was worn, as assessed via review of the mobile app
Results for this outcome have not been posted.
From photographs taken of the intervention materials at the 12 week assessment, the investigators will assess whether participants in the enhanced intervention group completed their values clarification activity
Results for this outcome have not been posted.
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Narrative Visualization | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Standard Self-regulation | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Narrative Visualization | Standard Self-regulation | Total |
|---|---|---|---|
| Mean | 61 ± 6.21 | 63 ± 4.86 | 62 ± 5.4 |
| Sex: Female, Male(Participants) | Narrative Visualization | Standard Self-regulation | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Narrative Visualization | Standard Self-regulation | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 16 | 19 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Narrative Visualization | Standard Self-regulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 14 | 13 | 27 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | Narrative Visualization | Standard Self-regulation | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators will provide access to all data, regardless of publication, collected as a part of this project. All external investigators must submit a written request identifying their research question(s) and specifying the data they would like to analyze. The request must include a data security plan and explanation of how the data will be stored and who will have access. All requests will be reviewed by the investigators in conjunction with UTMB's Institute for Translational Sciences key resources (in particular, the regulatory and ethics resources) to be sure appropriate NIH requirements are followed.
Supporting information: Study protocol, Sap
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The University of Texas Medical Branch, Galveston