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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Head and Neck Cancer; Esophageal Cancer; Lung Cancer
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health Services Research (PMSA); 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.

Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Use PSMA

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms	Baseline

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeffrey Friedman, Vanderbilt-Ingram Cancer Center

Publications and helpful links

Helpful Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: smartphone; pain management; application
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: VICC HN 14122; P30CA068485 (U.S. NIH Grant/Contract); NCI-2014-02426 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); VICCHN14122 (Other Identifier: Vanderbilt-Ingram Cancer Center)