Pain Management Smartphone Application for Patients With Stage III-IV Head and Neck Cancer Undergoing Radiation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study for a Pain Management Smartphone Application for Patients Undergoing Radiation Therapy for Locally Advanced Head and Neck Cancer

Conditions
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Pain, Head and Neck Cancer, Lung Cancer, Esophageal Cancer

Intervention / Treatment
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* Behavioral: Telephone-Based Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiation oncology patients undergoing 5-7 weeks of definitive radiation therapy for head and neck, esophageal or lung cancer. Ability to understand and the willingness to use the PMSA on the patient's personal smartphone Displays ability to use and understand the PMSA as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (PI) Willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires English speaking Exclusion Criteria: Radiation oncology patients undergoing palliative courses of radiation Patients who do not own smartphones Patients who are unable to successfully respond to the PMSA alarm and properly enter their data Patients who are unable to eat and drink normally Patients who are unable to validate their understanding of the pain scale

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Services Research (PMSA)<br>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. | Behavioral: Telephone-Based Intervention<br>* Use PSMA<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smartphone, application, pain management