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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03340714
Recruitment Status : Active, not recruiting
First Posted : November 13, 2017
Last Update Posted : December 1, 2022
Sponsor:
Collaborator:
Health Care Originals, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Carcinoma Device: Monitoring Device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : October 25, 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
Wear ADAMM


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device [ Time Frame: Up to 4 weeks post-radiation therapy ]
    The compliance rate along with a one-sided exact 95% confidence interval will be estimated.

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340714


Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Health Care Originals, Inc.
Investigators
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Principal Investigator: Maria Werner-Wasik, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
More Information
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Additional Information:

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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03340714    
Other Study ID Numbers: 17P.209
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases