Clinical trial NCT03612596: Narrative Visualization for Breast Cancer Survivors' Physical Activity
Official title: Narrative Visualization for Breast Cancer Survivors' Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: wearable
mobile app
physical activity
survivorship
narrative
identity
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-08-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Percentage of Daily Workbook Entries Completed
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Activity as Measured by Steps Per Day During Intervention Period
timeFrame: Change from 0 to 12 weeks
measure: Physical Activity as Measured by Daily Steps During No-intervention Maintenance Period
timeFrame: Change from 12 to 24 weeks
measure: Intrinsic Regulation
timeFrame: Change from 0 to 12 weeks
measure: Integrated Regulation
timeFrame: Change from 0 to 12 weeks
measure: Basic Psychological Needs: Autonomy
timeFrame: Change from 0 to 12 weeks
measure: Exercise Identity
timeFrame: Change from 0 to 12 weeks
measure: Basic Psychological Needs: Competence
timeFrame: 0 to 12 weeks
measure: Basic Psychological Needs: Relatedness
timeFrame: 0 to 12 weeks
measure: Self-reflection
timeFrame: Change from 0 to 12 weeks
measure: Quality of Life (Physical, Social, Emotional, Functional, and Breast Cancer-specific)
timeFrame: Change from 0 to 12 weeks
measure: Importance of Valued Domains
timeFrame: Change from 0 to 12 weeks
measure: Success in Living According to Valued Domains
timeFrame: Change from 0 to 12 weeks
measure: Engaged Living
timeFrame: Change from 0 to 12 weeks
Other outcomes:
measure: Receipt of Study Materials
timeFrame: 12 weeks
measure: Usefulness of Study Materials
timeFrame: 12 weeks
measure: Participant Attrition
timeFrame: 24 weeks
measure: Number of Serious Adverse Events
timeFrame: Up to 24 weeks
measure: Days the Activity Monitor Was Worn
timeFrame: 12 weeks
measure: Completion of Values Clarification Activity
timeFrame: 12 weeks
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Elizabeth J Lyons, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: