Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

Cancer Clinical Trial

Official title:

Incorporating Biometric Data Evaluation for Patients Receiving Concurrent Chemotherapy and Radiation Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05937659
• Other study ID #: LCCC2237
• Status: Not yet recruiting
• Start date: November 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: October 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Victoria Xu
• Phone: +1 984-974-8744
• Email: victoria_xu[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will assess the feasibility of incorporating biometric data via wearable health technology (WHT) into the radiation oncology (RO) clinic workflow for patients receiving concurrent radiation therapy and systemic therapy (CRT) for cancer. The investigators hypothesize that a practical workflow could be created within a busy community RO practice that will allow providers and patients to readily appreciate physiologic declines during concurrent CRT.

Subjects will be asked to wear a device as part of this study that will collect their biometric data (heart rate, number of steps taken per day, etc) called a WHT device throughout their treatment and for 4 weeks afterward. Subjects will be asked to upload the data from their devices onto the computers in the clinic for the assessment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Subjects

1. All genders aged = 18 years of age.

2. English-speakers

3. Able to understand and cooperate with study procedures.

4. Signed and dated informed consent.

5. Subjects being seen at Novant-New Hanover Regional Medical Center for diagnosis and management of cancer.

6. Subjects prescribed to receive concurrent radiation therapy and systemic therapy either definitively or postoperatively.

7. Signed and dated HIPAA authorization for the release of personal health information.

Providers

1. All genders aged = 18 years of age.

2. English speakers.

3. Able to understand and cooperate with study procedures.

4. Signed and dated informed consent.

Exclusion Criteria Both Subjects and care providers

1. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	Novant Health Cancer Institute Radiation Oncology	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of technology adoption	The rate of technology adoption will be quantified as the fraction of subjects who successfully download their WHT data into the research databases in the radiation oncology clinic. Success, on a subject-specific basis, will be defined as their reporting any of their WHT biometric data on >40% of eligible days.	Up to 12 weeks
Secondary	Provider perception of the utility	The physician's and nurse's subjective assessment of the utility of having the subject's wearable health technology data such as enhanced dietary or hydration counseling, supportive medication alteration, and/or intravenous fluid hydration will be quantified, using a survey.	Up to 12 weeks
Secondary	Subject perception of the utility	The subjects' responses to the utility of wearable health technology data will be quantified using surveys.	Up to 12 weeks