Narrative Visualization for Breast Cancer Survivors' Physical Activity

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Narrative visualization; Behavioral: Standard self-regulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • The University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Narrative visualization; Wearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content)	Behavioral: Narrative visualization; 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
Active Comparator: Standard self-regulation; 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 self-monitor steps using a wearable device, app, and a hand-written step log

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of Study Materials	Self-reported percent of study materials received out of total supplied	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)	12 weeks
Participant Attrition	Number of participants in each group who are lost to follow-up	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)	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	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	12 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elizabeth J Lyons, PhD, MPH, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; wearable; survivorship; mobile app; narrative; identity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 17-0310; 1R21CA218543-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will only be available upon request
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No