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Completed

NCT Number: NCT02324881

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-Based Intervention

Behavioral

Use PSMA

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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

  1. Number of additional OTVs prompted by usage of the application

    Time frame: 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.

Other outcomes

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

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2014
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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