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

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ClinicalTrials.gov Identifier: NCT02324881
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeffrey Friedman, Vanderbilt-Ingram Cancer Center

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
Head and Neck Cancer Pain Lung Cancer Esophageal Cancer Behavioral: Telephone-Based Intervention Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pilot Study for a Pain Management Smartphone Application for Patients Undergoing Radiation Therapy for Locally Advanced Head and Neck Cancer
Study Start Date : December 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Ability to obtain consumer input to determine the optimal way to address and monitor the patient's symptoms [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324881


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeffrey Friedman Vanderbilt-Ingram Cancer Center

Additional Information:
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Responsible Party: Jeffrey Friedman, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02324881     History of Changes
Other Study ID Numbers: VICC HN 14122
NCI-2014-02426 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VICCHN14122 ( Other Identifier: Vanderbilt-Ingram Cancer Center )
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Jeffrey Friedman, Vanderbilt-Ingram Cancer Center:
smartphone
application
pain management

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Esophageal Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases