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A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device: smartphone
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring pain, coping, mhealth, Breast cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile Health Pain Coping Skills Training (mPCST)

Arm Description

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).

Outcomes

Primary Outcome Measures

Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)

Secondary Outcome Measures

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.
Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire.
Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms.
Change in fatigue
The Patient Reported Outcomes Measurement Information System (PROMIS) four-item Fatigue Scale is a self-report measure of fatigue symptoms.
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
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.

Full Information

First Posted
May 24, 2016
Last Updated
August 15, 2019
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02783755
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
pain, coping, mhealth, Breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Health Pain Coping Skills Training (mPCST)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Device: smartphone
Intervention Description
Coping Skills Training for pain will be delivered to participants using video-conferencing
Primary Outcome Measure Information:
Title
Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
Time Frame
Baseline and post intervention, approximately 60 minutes
Title
Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)
Time Frame
Baseline and Post Intervention, approximately 60 minutes
Secondary Outcome Measure Information:
Title
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.
Time Frame
Baseline and Post Intervention, approximately 60 minutes
Title
Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire.
Time Frame
Baseline and Post Intervention, approximately 60 minutes
Title
Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms.
Time Frame
Baseline and Post Intervention, approximately 60 minutes
Title
Change in fatigue
Description
The Patient Reported Outcomes Measurement Information System (PROMIS) four-item Fatigue Scale is a self-report measure of fatigue symptoms.
Time Frame
Baseline and Post Intervention, approximately 60 minutes
Title
Change in mPCST Acceptability, as measured by participants' engagement
Description
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
Time Frame
Sessions 2,3,4 and 5
Title
change in Health-Related Quality of Life
Description
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.
Time Frame
Baseline and Post Intervention, approximately 60 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara J Somers, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities

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