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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868746
• Other study ID #: STUDY02000934_1B
• Secondary ID: IRG-21-136-36-IR
• Status: Recruiting
• Start date: June 8, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Courtney J Stevens, PhD
• Phone: 6036465451
• Email: courtney.j.stevens[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Clinic	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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
Secondary	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
Secondary	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