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

NCT05868746 | Completed DMC

• 2 other identifiers: STUDY02000934_1BIRG-21-136-36-IRG
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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."

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Proportion of the sample with valid accelerometer data at the end of the 10-day data collection period.

  10 day data collection period

• Rate of phone-based ecological momentary assessment (EMA) prompt completion.

  10 day data collection period

• Rate of electronic daily dairy completion.

  10 day data collection period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Courtney J Stevens, PhD

  Dartmouth-Hitchcock Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 22, 2023
• Study Start: June 16, 2023
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)