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

NCT ID: NCT05868746

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-16

Study Completion Date

2024-06-18

Brief Summary

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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."

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Courtney J. Stevens

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Courtney J Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Health

Locations

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Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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IRG-21-136-36-IRG

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY02000934_1B

Identifier Type: -

Identifier Source: org_study_id

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