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

Not Applicable

Completed

• Conditions: Pain; Esophageal Cancer; Head and Neck Cancer; Lung Cancer
• Interventions: Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration

• Registration Number: NCT02324881
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health Services Research (PMSA)	Telephone-Based Intervention	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.
Health Services Research (PMSA)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Compliance characteristics of patients' use of the pain management smartphone application	Up to day 50	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.

Secondary Outcome Measures

Name	Time	Method
Number of additional OTVs prompted by usage of the application	Up to day 50	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.

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States