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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02426 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VICCHN14122 | Other Identifier | Vanderbilt-Ingram Cancer Center | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. The study is also open to patients with esophageal or lung cancer. A smartphone application may allow patients to assess their symptoms in a manner that is closer to real-time than having to recall pain episodes during once weekly on-treatment visits with a health care provider. This real-time monitoring may improve the timing and efficacy of interventions leading to better pain-control and quality of life.
PRIMARY OBJECTIVES:
I. Obtain consumer input to determine the optimal way to address and monitor the patient's symptoms.
II. Train patients to use the pain management smartphone application (PMSA) and determine the compliance characteristics and the number of additional on-treatment visits (OTVs) prompted by usage of the application.
OUTLINE:
Selected patients are interviewed for input that will help guide the wording of questions of the PMSA. All patients/caregivers are then instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50), although the timing may change based on the availability of the app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Services Research (PMSA) | Experimental | Patients/caregivers are instructed to download the PMSA and are demonstrated how to properly use the application. Beginning on the first day of radiation therapy (day 1), patients are instructed to use the PMSA for the duration of their radiation therapy (up to day 50). The patient will fill out a satisfaction questionnaire at the completion of their treatment (Questionnaire administration). The timing of use may change depending on the availability of the app. The use of the app is classified as the "telephone-based intervention" per NCI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-Based Intervention | Behavioral | Use PSMA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance characteristics of patients' use of the pain management smartphone application | Summaries of feasibility will be generated using rates (percentages). Descriptive statistics will be used to summarize patient ratings of satisfaction regarding the PMSA, instruction, usage, and future recommendation. | Up to day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of additional OTVs prompted by usage of the application | The additional OTVs per patient will analyzed with descriptive statistics, such as frequency distributions, means, medians and measures of variability will be used to describe the OTV number changes. | Up to day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Friedman | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| Questionnaire Administration |
| Other |
Ancillary studies |
|
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010146 | Pain |
| D008175 | Lung Neoplasms |
| D004938 | Esophageal Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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