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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03340714
Enrollment
24
Registered
2017-11-13
Start date
2018-03-20
Completion date
2023-09-25
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Carcinoma

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

Interventions

Wear ADAMM

Sponsors

Health Care Originals, Inc.
CollaboratorUNKNOWN
Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management deviceUp to 4 weeks post-radiation therapyThe 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 deviceUp to 4 weeks post-radiation therapyThe compliance rate along with a one-sided exact 95% confidence interval will be estimated.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026