RECRUITING

WATD and Cancer-Related Fatigue: A Study For Patients Undergoing Anti-Cancer Treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the feasibility of using a commercial WATD (Wearable Activity Tracker Device) to collect HRV (Heart Rate Variability) data from pancreatic and breast cancer patients.

Official Title

Wearable Activity Tracker Devices and Cancer-Related Fatigue: A Clinical Utility Pilot Study For Patients Undergoing Anti-Cancer Treatment

Quick Facts

Study Start:2024-10-04

Study Completion:2025-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06291324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Written informed consent and HIPAA authorization for release of personal health information * Patients pancreatic or invasive breast cancer per enrolling investigator who is planning on or has started anti-cancer treatment. Note: Patients with cancer who are not planning to receive anti-cancer treatment are not eligible for study participation * Patients with any severity of self-reported fatigue per enrolling investigator * Age ≥ 18 years at the time of consent * Ability to read and understand the English language * As determined by the enrolling investigator, the ability of the participant to understand and comply with study procedures (i.e., completing questionnaires and device return) for the entire length of the study	* Any documented, clinically significant cardiac-related abnormality per enrolling investigator that could compromise the outcome of the study. NOTE: The heart rate data collected using the WATD will not be used for patient care. * Other factors or conditions, per investigator discretion, for which participation in the study would not be in the patient's best interest or could interfere with study assessment results or preclude study completion * No internet, Wi-Fi access or email account * No access to a smartphone or mobile device

Inclusion Criteria

Exclusion Criteria

* Written informed consent and HIPAA authorization for release of personal health information
* Patients pancreatic or invasive breast cancer per enrolling investigator who is planning on or has started anti-cancer treatment. Note: Patients with cancer who are not planning to receive anti-cancer treatment are not eligible for study participation
* Patients with any severity of self-reported fatigue per enrolling investigator
* Age ≥ 18 years at the time of consent
* Ability to read and understand the English language
* As determined by the enrolling investigator, the ability of the participant to understand and comply with study procedures (i.e., completing questionnaires and device return) for the entire length of the study

* Any documented, clinically significant cardiac-related abnormality per enrolling investigator that could compromise the outcome of the study. NOTE: The heart rate data collected using the WATD will not be used for patient care.
* Other factors or conditions, per investigator discretion, for which participation in the study would not be in the patient's best interest or could interfere with study assessment results or preclude study completion
* No internet, Wi-Fi access or email account
* No access to a smartphone or mobile device

Contacts and Locations

Study Contact

Alicia Patrick

CONTACT

980-292-1746

alicia.patrick@atriumhealth.org

Principal Investigator

Dori Beeler, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Dori Beeler, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-04

Study Completion Date2025-12-15

Study Record Updates

Study Start Date2024-10-04

Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

Fatigue

Additional Relevant MeSH Terms

Pancreatic Cancer
Breast Cancer