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

Completed

• Conditions: Lung Carcinoma
• Interventions: Device: Monitoring Device

• Registration Number: NCT03340714
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-03-20
• Primary Completion: 2021-10-25
• Study Completion: 2023-09-25
• Status Verified: 2024-01
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device Feasibility (ADAMM)	Monitoring Device	Patients wear the Automated Device for Asthma Monitoring and Management (ADAMM) from the time of computed tomography (CT) simulation for radiation therapy (RT) planning throughout the entire RT course and for 4 weeks post-RT

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States