Pain Management Smartphone Application for Patients With Stage III-IV Head and Neck Cancer Undergoing Radiation Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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Obtain consumer input to determine the optimal way to address and monitor the patient's symptoms.
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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 Design
Arms and Interventions
| 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. |
Behavioral: Telephone-Based Intervention
Use PSMA
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Compliance characteristics of patients' use of the pain management smartphone application [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 Outcome Measures
- Number of additional OTVs prompted by usage of the application [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 Outcome Measures
- Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms [Baseline]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Radiation oncology patients undergoing 5-7 weeks of definitive radiation therapy for head and neck, esophageal or lung cancer.
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Ability to understand and the willingness to use the PMSA on the patient's personal smartphone
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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)
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Willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires
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English speaking
Exclusion Criteria:
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Radiation oncology patients undergoing palliative courses of radiation
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Patients who do not own smartphones
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Patients who are unable to successfully respond to the PMSA alarm and properly enter their data
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Patients who are unable to eat and drink normally
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Patients who are unable to validate their understanding of the pain scale
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jeffrey Friedman, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- VICC HN 14122
- NCI-2014-02426
- VICCHN14122
- P30CA068485