Clinical trial NCT02324881: Pain Management Smartphone Application for Patients With Stage III-IV Head and Neck Cancer Undergoing Radiation Therapy
Official title: A Pilot Study for a Pain Management Smartphone Application for Patients Undergoing Radiation Therapy for Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Pain
Lung Cancer
Esophageal Cancer
Keywords: smartphone
application
pain management
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-12-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Compliance characteristics of patients' use of the pain management smartphone application
timeFrame: Up to day 50
Secondary outcomes:
measure: Number of additional OTVs prompted by usage of the application
timeFrame: Up to day 50
Other outcomes:
measure: Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms
timeFrame: Baseline
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jeffrey Friedman
role: PRINCIPAL_INVESTIGATOR
References: