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Narrative Visualization for Breast Cancer Survivors' Physical Activity

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative visualization
Standard self-regulation
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring wearable, mobile app, physical activity, survivorship, narrative, identity

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Narrative visualization

Standard self-regulation

Arm Description

Wearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content)

Wearable activity monitor, app, and standard workbook materials (markers, a workbook with a calendar log to keep track of steps over time)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical Activity as Measured by Steps Per Day During Intervention Period
Mean of daily steps taken from accelerometers worn for 7 days
Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period
Mean of steps per day taken from accelerometers worn for 7 days
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 25, 2018
Last Updated
June 7, 2023
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03612596
Brief Title
Narrative Visualization for Breast Cancer Survivors' Physical Activity
Official Title
Narrative Visualization for Breast Cancer Survivors' Physical Activity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
wearable, mobile app, physical activity, survivorship, narrative, identity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrative visualization
Arm Type
Experimental
Arm Description
Wearable activity monitor, app, and enhanced motivational scrapbook materials (instant camera, stickers, markers, enhanced content)
Arm Title
Standard self-regulation
Arm Type
Active Comparator
Arm Description
Wearable activity monitor, app, and standard workbook materials (markers, a workbook with a calendar log to keep track of steps over time)
Intervention Type
Behavioral
Intervention Name(s)
Narrative visualization
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard self-regulation
Intervention Description
Participants self-monitor steps using a wearable device, app, and a hand-written step log
Primary Outcome Measure Information:
Title
Percentage of Daily Workbook Entries Completed
Description
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
Secondary Outcome Measure Information:
Title
Physical Activity as Measured by Steps Per Day During Intervention Period
Description
Mean of daily steps taken from accelerometers worn for 7 days
Time Frame
Change from 0 to 12 weeks
Title
Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period
Description
Mean of steps per day taken from accelerometers worn for 7 days
Time Frame
Change from 12 to 24 weeks
Title
Intrinsic Regulation
Description
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
Title
Integrated Regulation
Description
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
Title
Basic Psychological Needs: Autonomy
Description
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
Title
Exercise Identity
Description
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
Title
Basic Psychological Needs: Competence
Description
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
Title
Basic Psychological Needs: Relatedness
Description
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
Title
Self-reflection
Description
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
Title
Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific)
Description
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
Title
Importance of Valued Domains
Description
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
Title
Success in Living According to Valued Domains
Description
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
Title
Engaged Living
Description
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
Other Pre-specified Outcome Measures:
Title
Receipt of Study Materials
Description
Self-reported percent of study materials received out of total supplied
Time Frame
12 weeks
Title
Usefulness of Study Materials
Description
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
Title
Participant Attrition
Description
Number of participants in each group who are lost to follow-up
Time Frame
24 weeks
Title
Number of Serious Adverse Events
Description
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
Title
Days the Activity Monitor Was Worn
Description
The number of days the activity monitor was worn, as assessed via review of the mobile app
Time Frame
12 weeks
Title
Completion of Values Clarification Activity
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must self-report as women
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J Lyons, PhD, MPH
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Narrative Visualization for Breast Cancer Survivors' Physical Activity

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