Clinical trial NCT05868746: An Observational Pilot Study to Test a Smartwatch-based EMA Method During Exercise With Breast Cancer Survivors
Official title: Measuring Breast Cancer Survivor's Subjective Responses to Exercise Using a Novel, Smartwatch-based EMA Method: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2023-05-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under the care of a Dartmouth Cancer Center oncology provider.

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."


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.

Primary outcomes:
measure: 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.
timeFrame: 10 day data collection period
measure: Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured using the System Usability Scale.
timeFrame: End of study follow-up (post 10-day data collection period)
measure: Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview.
timeFrame: End of study follow-up (post 10-day data collection period)
Secondary outcomes:
measure: Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period.
timeFrame: 10 day data collection period
measure: Rate of phone-based ecological momentary assessment (EMA) prompt completion.
timeFrame: 10 day data collection period
measure: Rate of electronic daily dairy completion.
timeFrame: 10 day data collection period
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Clinic
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Health
name: Courtney J Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: