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

NCT ID: NCT03340714

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-20

Study Completion Date

2023-09-25

Brief Summary

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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

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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

Conditions

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Lung Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Monitoring Device

Intervention Type DEVICE

Wear ADAMM

Interventions

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Monitoring Device

Wear ADAMM

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Care Originals, Inc.

UNKNOWN

Sponsor Role collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Werner-Wasik, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

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Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

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JT 10294

Identifier Type: OTHER

Identifier Source: secondary_id

17P.209

Identifier Type: -

Identifier Source: org_study_id

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