Esophageal Cancer, Head and Neck Cancer, Lung Cancer, Pain
Conditions
Keywords
smartphone, application, pain management
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.
Interventions
BEHAVIORALTelephone-Based Intervention
Use PSMA
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms | Baseline |
Countries
United States
Outcome results
None listed