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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324881
• Other study ID #: VICC HN 14122
• Secondary ID: NCI-2014-02426VI
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: July 12, 2016
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Pain

Intervention

Behavioral:
• Telephone-Based Intervention
Use PSMA

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms		Baseline	No
Primary	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	No
Secondary	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	No

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial