A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities

NCT02783755 | Completed

• 1 other identifier: Pro00065621
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

pain; coping; mhealth; Breast cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  Baseline and Post Intervention, approximately 60 minutes

• Change in mPCST Acceptability, as measured by participants' engagement

  Sessions 2,3,4 and 5

Study Arms (1)

Mobile Health Pain Coping Skills Training (mPCST)

EXPERIMENTAL

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

Interventions

Device: smartphone BEHAVIORAL

Coping Skills Training for pain will be delivered to participants using video-conferencing

Mobile Health Pain Coping Skills Training (mPCST)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamara J Somers, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 26, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 30, 2017
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)