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Clinical Trials/NCT02324881
NCT02324881
Completed
Not Applicable

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

Vanderbilt-Ingram Cancer Center1 site in 1 country24 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Vanderbilt-Ingram Cancer Center
Enrollment
24
Locations
1
Primary Endpoint
Compliance characteristics of patients' use of the pain management smartphone application
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
October 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Friedman

Principal Investigator

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Compliance characteristics of patients' use of the pain management smartphone application

Time Frame: 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 Outcomes

  • Number of additional OTVs prompted by usage of the application(Up to day 50)

Study Sites (1)

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