Lung Carcinoma Clinical Trial
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
| NCT number | NCT03340714 |
| Other study ID # | 17P.209 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 20, 2018 |
| Est. completion date | September 25, 2023 |
| Verified date | January 2024 |
| Source | Thomas Jefferson University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | September 25, 2023 |
| Est. primary completion date | October 25, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Health Care Originals, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
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