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

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

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."

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Courtney J Stevens, PhD; Phone Number: 6036465451; Email: courtney.j.stevens@dartmouth.edu
• Study Contact Backup: Name: Hannah C Edmonds, MPH; Phone Number: 6036465471; Email: hannah.c.edmonds@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Clinic
      • Contact: Courtney J Stevens, PhD; Phone Number: 603-646-5451; Email: courtney.j.stevens@dartmouth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients under the care of a Dartmouth Cancer Center oncology provider.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	10 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.	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.	End of study follow-up (post 10-day data collection period)
Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview.	Semi-structured interview to assess participants' perceptions regarding their experience using the smartwatch-based ecological momentary assessment method.	End of study follow-up (post 10-day data collection period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period.	The number of participants with valid accelerometer data out of the total number of participants in the sample during the 10-day data collection period.	10 day data collection period
Rate of phone-based ecological momentary assessment (EMA) prompt completion.	The number of phone-based EMA survey prompts completed by participants during the 10-day data collection period out of the total number of phone-based EMA survey prompts delivered to participants.	10 day data collection period
Rate of electronic daily dairy completion.	The number of electronic daily dairies completed by participants during the 10-day data collection period out of the total number of electronic daily dairies delivered to participants.	10 day data collection period

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Courtney J Stevens, PhD, Dartmouth-Hitchcock Health

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STUDY02000934_1B; IRG-21-136-36-IRG (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No