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Clinical Trials/NCT05868746
NCT05868746
Completed
Not Applicable

Measuring Breast Cancer Survivor's Subjective Responses to Exercise Using a Novel, Smartwatch-based EMA Method: A Pilot Study

Dartmouth-Hitchcock Medical Center1 site in 1 country27 target enrollmentJune 16, 2023
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
27
Locations
1
Primary Endpoint
Feasibility of using a smartwatch-based ecological momentary assessment (EMA) method during exercise measured as the proportion of participants who use the data collection app and provided at least 3 responses to EMAs during a single exercise session.
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this pilot study is to evaluate the feasibility and acceptability of collecting ecological momentary assessment data regarding feeling states during physical activity among a cohort of breast cancer survivors, using a novel smartwatch app created by the study team called "PHITbit."

Registry
clinicaltrials.gov
Start Date
June 16, 2023
End Date
June 18, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Courtney J. Stevens

Assistant Professor of Psychiatry

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Inclusion Criteria

  • Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer.
  • Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during the assessment period.
  • Willing to wear the ActiGraph monitor during the assessment period.
  • Willing to wear the study issued Fitbit Versa 3 smartwatch during the assessment period.
  • Access to internet to complete REDCap survey assessments.

Exclusion Criteria

  • Non-English speaking/not able to read English.
  • Evidence of major contraindications for exercise per the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+.
  • Currently pregnant.
  • History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium).
  • Evidence of moderate-severe depressive symptoms (indicated by a score ≥ 10 on Patient Health Questionnaire-8). -Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6- item cognitive screener).
  • Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE-AID screener.

Outcomes

Primary Outcomes

Feasibility of using a smartwatch-based ecological momentary assessment (EMA) method during exercise measured as the proportion of participants who use the data collection app and provided at least 3 responses to EMAs during a single exercise session.

Time Frame: 10 day data collection period

The number of participants who use the smartwatch data collection app and respond to at least 3 EMAs during a single exercise session at least once during the 10-day data collection period out of the total number of participants enrolled at the end of the10-day data collection period.

Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured using the System Usability Scale.

Time Frame: End of study follow-up (post 10-day data collection period)

The System Usability Scale (SUS) is a 10-item self-report scale used to measure perceived usability of a system, method, or tool. Responses on the SUS range from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater acceptability.

Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview.

Time Frame: End of study follow-up (post 10-day data collection period)

Semi-structured interview to assess participants' perceptions regarding their experience using the smartwatch-based ecological momentary assessment method.

Secondary Outcomes

  • Rate of electronic daily dairy completion.(10 day data collection period)
  • Rate of phone-based ecological momentary assessment (EMA) prompt completion.(10 day data collection period)
  • Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period.(10 day data collection period)

Study Sites (1)

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