Narrative Visualization for Breast Cancer Survivors' Physical Activity

NCT ID: NCT03612596

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-03-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Narrative visualization

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

Group Type: EXPERIMENTAL

Narrative visualization

Intervention Type: BEHAVIORAL

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

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)

Group Type: ACTIVE_COMPARATOR

Standard self-regulation

Intervention Type: BEHAVIORAL

Participants self-monitor steps using a wearable device, app, and a hand-written step log

Interventions

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

Intervention Type: BEHAVIORAL

Standard self-regulation

Participants self-monitor steps using a wearable device, app, and a hand-written step log

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth J Lyons, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

The University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21CA218543-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-0310

Identifier Type: -

Identifier Source: org_study_id