Skip to main content
OpenTrials
Completed

NCT Number: NCT05868746

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

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."

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 10 day data collection period

    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.

  2. Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured using the System Usability Scale.

    Time frame: End of study follow-up (post 10-day data collection period)

    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.

  3. Acceptability of collecting during-exercise feeling state data using a smartwatch-based ecological momentary assessment method measured via a semi-structured interview.

    Time frame: End of study follow-up (post 10-day data collection period)

    Semi-structured interview to assess participants' perceptions regarding their experience using the smartwatch-based ecological momentary assessment method.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 10 day data collection period

    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.

  3. Rate of electronic daily dairy completion.

    Time frame: 10 day data collection period

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.