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A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities

Breast Cancer Clinical Trial

Official title:
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.

Clinical Trial Summary

The purpose of this study is two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone components with the assistance of experts in the field. Next, an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mPCST protocol and basic smart phone components. The protocol—designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas—will be delivered via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g., simple text messages, images, and preloaded intervention content) will allow the intervention to extend into the patients' homes. The second study purpose is to pilot test the feasibility, acceptability, and efficacy of the developed protocol. The investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus group data will be managed and evaluated in a systematic format using a grounded theory approach. Data analyses for the pilot testing period of the study will be assessed by examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest. There are minimal risk or safety issues related to this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02783755
Study type Interventional
Source Duke University
Contact
Status Completed
Phase N/A
Start date May 2016
Completion date June 30, 2017
View Details
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