A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities

Study Overview
=================
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.

Official Title
-----------------
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Device: smartphone


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health Pain Coping Skills Training (mPCST)<br>Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms). | Behavioral: Device: smartphone<br>* Coping Skills Training for pain will be delivered to participants using video-conferencing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain severity will be assessed with the Brief Pain Inventory (BPI). |  | Baseline and post intervention, approximately 60 minutes | 
| Change in pain Interference will be assessed with the Brief Pain Inventory (BPI) |  | Baseline and Post Intervention, approximately 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Baseline and Post Intervention, approximately 60 minutes | 
| Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire. |  | Baseline and Post Intervention, approximately 60 minutes | 
| Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms. |  | Baseline and Post Intervention, approximately 60 minutes | 
| Change in fatigue | The Patient Reported Outcomes Measurement Information System (PROMIS) four-item Fatigue Scale is a self-report measure of fatigue symptoms. | Baseline and Post Intervention, approximately 60 minutes | 
| Change in mPCST Acceptability, as measured by participants' engagement | Patient acceptability of mPCST will be assessed with the Client Satisfaction Questionnaire 10-item version that rates items from 1 = low acceptability and 4 = high acceptability | Sessions 2,3,4 and 5 | 
| change in Health-Related Quality of Life | The Functional Assessment of Cancer Therapy- General (FACT-G) will be used to assess participants' health-related quality of life. The FACT-G is a 7-item self-report measure that provides participants with a variety of symptoms and concerns. | Baseline and Post Intervention, approximately 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, coping, mhealth, Breast cancer