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

Primary Purpose

Lung Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monitoring Device
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Feasibility (ADAMM)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2017
Last Updated
August 14, 2023
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Health Care Originals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03340714
Brief Title
Automated Device for Asthma Monitoring and Management in Monitoring Adults With Lung Cancer Undergoing Radiation Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Health Care Originals, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device Feasibility (ADAMM)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Monitoring Device
Intervention Description
Wear ADAMM
Primary Outcome Measure Information:
Title
Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device
Description
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Time Frame
Up to 4 weeks post-radiation therapy
Title
Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device
Description
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Time Frame
Up to 4 weeks post-radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Werner-Wasik, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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