A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:10/5/2018
Start Date:May 2016
End Date:June 30, 2017

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A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.

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.


Inclusion Criteria:

- diagnosis of breast cancer within the last three years

- being >21 years old,

- having a life expectancy of at least 12 months,

- having 1 clinical pain ratings of >3 gathered as part of their routine clinic visits

Exclusion Criteria:

- metastases to the brain,

- presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a
psychiatric condition (e.g., suicidal intent) that would contraindicate safe
participation in the study as indicated by the medical chart, treating oncologist, or
interactions with the medical/study staff,

- current or past (<6 months) engagement in PCST for cancer.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Tamara J Somers, PhD
Phone: 919-416-3408
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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