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NCT03340714 Clinical Trial

Automated Device for Asthma Monitoring and Management in Monitoring Adults With Lung Cancer Undergoing Radiation Therapy

Lung Carcinoma Clinical Trial

Official title:
A Pilot Study Investigating the Feasibility of ADAMM (Automated Device for Asthma Monitoring and Management) in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03340714
Other study ID # 17P.209
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2018
Est. completion date September 25, 2023

Study information
Verified date January 2024
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.

Description:

PRIMARY OBJECTIVES: I. Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer. SECONDARY OBJECTIVES: I. Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date September 25, 2023
Est. primary completion date October 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients are capable of giving informed consent - Patients are eligible to be treated with RT and plan to start treatment - Patients have either metastatic or non-metastatic lung cancer as defined in history and physical - Patients must be able to read or speak English - Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan Exclusion Criteria: - Patients who cannot read or speak English - Patients who are not candidates for RT treatment - Women of childbearing potential who are pregnant or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Monitoring Device
Wear ADAMM

Locations
Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University Health Care Originals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device The compliance rate along with a one-sided exact 95% confidence interval will be estimated. Up to 4 weeks post-radiation therapy
Primary Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device The compliance rate along with a one-sided exact 95% confidence interval will be estimated. Up to 4 weeks post-radiation therapy
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