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

NCT03340714 | Completed DMC

• 2 other identifiers: 17P.209JT 10294
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Device Feasibility (ADAMM)

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

Device: Monitoring Device

Interventions

Monitoring Device DEVICE

Wear ADAMM

Device Feasibility (ADAMM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic and non-metastatic lung cancer being treated with radiotherapy

You may qualify if:

• 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

You may not qualify if:

• Patients who cannot read or speak English
• Patients who are not candidates for RT treatment
• Women of childbearing potential who are pregnant or breastfeeding

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Health Care Originals, Inc.: collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maria Werner-Wasik, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: March 20, 2018
• Primary Completion: October 25, 2021
• Study Completion: September 25, 2023
• Last Updated: May 15, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)