A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Device: smartphone

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mobile Health Pain Coping Skills Training (mPCST); 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; Coping Skills Training for pain will be delivered to participants using video-conferencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: pain; Breast cancer; coping; mhealth
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: Pro00065621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO