An Observational Pilot Study to Test a Smartwatch-based EMA Method During Exercise With Breast Cancer Survivors

Dartmouth Health

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05868746

STUDY02000934_1B

IRG-21-136-36-IRG (Other Grant/Funding Number)

Details and patient eligibility

About

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."

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.