Purpose

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.

Condition

Eligibility

Eligible Ages
Between 55 Years and 79 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

The University of Texas Medical Branch
Galveston, Texas 77550
Contact:
Eloisa Martinez
409-266-9643
esmartin@utmb.edu

More Details

NCT ID
NCT03612596
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Elosa Martinez, BA
409-266-9643
esmartin@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.