Clinical trial NCT02783755: A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities
Official title: A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: pain
coping
mhealth
Breast cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
timeFrame: Baseline and post intervention, approximately 60 minutes
measure: Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)
timeFrame: Baseline and Post Intervention, approximately 60 minutes
Secondary outcomes:
measure: Change in self-efficacy for pain control will be assessed with the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale.
timeFrame: Baseline and Post Intervention, approximately 60 minutes
measure: Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire.
timeFrame: Baseline and Post Intervention, approximately 60 minutes
measure: Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms.
timeFrame: Baseline and Post Intervention, approximately 60 minutes
measure: Change in fatigue
timeFrame: Baseline and Post Intervention, approximately 60 minutes
measure: Change in mPCST Acceptability, as measured by participants' engagement
timeFrame: Sessions 2,3,4 and 5
measure: change in Health-Related Quality of Life
timeFrame: Baseline and Post Intervention, approximately 60 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Tamara J Somers, PhD
role: PRINCIPAL_INVESTIGATOR
References: