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

NCT02324881 | Completed

• 4 other identifiers: VICC HN 14122NCI-2014-02426VICCHN14122P30CA068485
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Pain; Lung Cancer; Esophageal Cancer

Keywords

smartphone; application; pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of additional OTVs prompted by usage of the application

  Up to day 50

Other Outcomes (1)

• Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms

  Baseline

Study Arms (1)

Health Services Research (PMSA)

EXPERIMENTAL

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; Other: Questionnaire Administration

Interventions

Telephone-Based Intervention BEHAVIORAL

Use PSMA

Health Services Research (PMSA)

Questionnaire Administration OTHER

Ancillary studies

Health Services Research (PMSA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain; Lung Neoplasms; Esophageal Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Jeffrey Friedman

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (1)