Narrative Visualization for Breast Cancer Survivors' Physical Activity

NCT03612596 | Completed Results

• 2 other identifiers: 17-03101R21CA218543-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

wearable; mobile app; physical activity; survivorship; narrative; identity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Physical Activity as Measured by Steps Per Day During Intervention Period

  Change from 0 to 12 weeks

• Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period

  Change from 12 to 24 weeks

• Intrinsic Regulation

  Change from 0 to 12 weeks

• Integrated Regulation

  Change from 0 to 12 weeks

• Basic Psychological Needs: Autonomy

  Change from 0 to 12 weeks

Other Outcomes (6)

• Receipt of Study Materials

  12 weeks

• Usefulness of Study Materials

  12 weeks

• Participant Attrition

  24 weeks

Study Arms (2)

Narrative visualization

EXPERIMENTAL

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

Behavioral: Narrative visualization

Standard self-regulation

ACTIVE COMPARATOR

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

Interventions

Narrative visualization 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

Narrative visualization

Standard self-regulation BEHAVIORAL

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

Standard self-regulation

Eligibility Criteria

• Age: 55 Years - 79 Years
• Gender Eligibility Details: Participants must self-report as women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Narration

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Communication

Limitations and Caveats

Missing data were imputed except for 3 participants with data missing at baseline. Results should be interpreted with caution due to the pilot nature of the trial and data collection occurring partially during spring/summer 2020. Several outcomes (valued and engaged living, quality of life) were changed from secondary to other pre-specified, as these are likely not interpretable due to external factors (e.g., COVID-19 and social distancing).

Results Point of Contact

• Title: Eloisa Martinez
• Organization: The University of Texas Medical Branch

esmartin@utmb.edu

409-266-9643

Study Officials

• Elizabeth J Lyons, PhD, MPH

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 2, 2018
• Study Start: September 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: March 31, 2022
• Last Updated: June 9, 2023
• Results First Posted: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will only be available upon request
• 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.

Locations

US (1)