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mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients (ICAN-NC)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Pain Coping Skills Training (mPCST)
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 cancer, pain, fatigue, distress, coping, mHealth, symptom management, physical disability

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. women with a diagnosis of any breast cancer within the last three years
  2. being >18 years old
  3. having a life expectancy of >12 months
  4. report experiencing pain on at least 10 days in the last month and rate their pain in the past week as a 4 or greater on a 0-10 scale. The combination of these items assess patients level of persistent pain (in the last month) and pain severity with an accurate recall period (i.e., last week; >4).

Exclusion Criteria:

  1. cognitive impairment as indicated by a baseline Folstein Mini-Mental Status Examination of <2588
  2. brain metastases
  3. presence of a severe psychiatric condition 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 medical/study staff interactions, or 4) current or past (<6 months) engagement in PCST for cancer.

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Health Pain Coping Skills Training (mPCST)

mHealth-Education (mHealth-Ed)

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).

mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.

Outcomes

Primary Outcome Measures

Change in pain severity
Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about worst, least, average and now pain on a 0 = no pain to 10 = pain as bad as you can imagine.
Change in Pain Interference
Pain Interference will be assessed by asking how much pain has interfered with seven daily activities including general activity, walking, work, mood, enjoyment of life, relations with other and sleep within the last 7 days on a 0 = does not interfere to 10 = completely interferes
Change in fatigue
The Patient Reported Outcomes Measurement Information System (PROMIS) six-item Fatigue Scale is a self-report measure of fatigue symptoms. Items ask patients to evaluate symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities.
Change in Physical Disability
Physical disability will be assessed using 4-item form Patient Care Monitor (PCM) scale. The four items ask about patients' ability to run, do light physical work or fun activities, do hard physical work or fun activities, and ability to function normally in the last 7 days (0 = not a problem to 10 = as bad as possible).

Secondary Outcome Measures

Change in Self-Efficacy for pain control
The self-efficacy for pain management will be assessed using 5-item Chronic Pain Self-Efficacy scale. This sub-scale contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication. This item will be answered on a 10 = very uncertain to 100 = very certain scale and are averaged.
Change in Pain Catastrophizing
Pain catastrophizing will be assessed with the 6-item pain catastrophizing sub-scale of the Coping Strategies Questionnaire. These items ask about patients tendency to catastrophizing when faced with pain and are answered on a 0 = never to 6 = always
Cost-Effectiveness
We will create a composite cost variable based on patient time, medical resource use, productivity, and the EQ-5D.The EQ-5D is a measure of health status that can be linked to population-based preference weights is widely used in economic evaluations. It is short, assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The respondent indicates no problems, some problems, or severe problems in each dimension.

Full Information

First Posted
November 21, 2019
Last Updated
September 1, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04175639
Brief Title
mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients
Acronym
ICAN-NC
Official Title
mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention - a non-pharmacological approach to pain management. The proposed project's objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients with pain in medically underserved areas. mPCST-Community addresses intervention barriers for patients in medically underserved areas as it is delivered with video-conferencing in the patients' community based oncology clinic by a remote therapist, is extended to the patients' home environment using simple mHealth technology, and is low-literacy adapted. The central hypothesis is that mPCST-Community will result in decreased pain compared to a mHealth education attention control group (mHealth-Ed). The rationale of this proposal is that if mPCST-Community is shown to be efficacious it will rapidly increase intervention access for individuals who receive their oncology care in medically underserved areas and ultimately reduce pain-related suffering. Guided by strong preliminary data, a randomized controlled trial will be used to pursue three specific aims: 1) Test the extent to which the mPCST-Community intervention reduces pain, fatigue, disability, and distress, 2) Examine self-efficacy and pain catastrophizing as mediators through which the mPCST-Community leads to reductions in pain, fatigue, disability, and distress, and 3) To evaluate the cost-effectiveness of mPCST-Community. For Aim 1, based on the study team's extensive work demonstrating the efficacy of in-person pain coping skills training protocols and pilot work showing promise for mPCST-Community, it is expected that mPCST-Community will lead to decreased pain as well as fatigue, disability, and distress compared to mHealth-Ed. For Aim 2, it is expected that the effects of mPCST-Community will be mediated by increased self-efficacy for pain control and decreased pain catastrophizing. For Aim 3, it is expected that mPCST-Community will demonstrate cost-effectiveness as assessed by all-cause medical resource use, participant and therapist time, and health utilities as well as successful overall accrual, high subject retention, and high intervention adherence.
Detailed Description
Guided by extensive prior work, the investigators have designed an innovative mHealth behavioral pain coping skills training (PCST) intervention to reduce pain and disability in cancer patients in medically underserved areas (mPCST-Community). Our prior work has tested PCST protocols through in-person sessions at major medical centers where resources and literacy levels are relatively high. mPCST-Community is different and innovative; it uses mHealth technology (e.g., videoconferencing) to decrease access barriers for patients in medically underserved areas. The protocol is brief (4 sessions) and delivered in the community clinic by a remote well-trained pain therapist. Importantly, this protocol has been carefully adapted for low literacy patients.Beverly Thorn, PhD, a nationally recognized expert in strategies for adapting pain coping interventions to low literacy, medically underserved patients, was instrumental in developing the mPCST-Community protocol. mPCST-Community extends to the patient's daily life through use of a simple mobile application that provides low literacy text/audio protocol summaries, relaxation audio, daily assessment and personalized feedback, and coping messaging. The investigators propose a randomized controlled trial (RCT) to test the efficacy of the developed mPCST-Community protocol in breast cancer patients with pain receiving cancer care in medically underserved areas (N=180). The investigators have done careful and extensive pilot work to prepare for the proposed trial. Our pilot work (Journal of Psychosocial Oncology) was conducted in breast cancer patients with pain in three medically underserved rural community clinics. First, focus group data (3 groups; n=19) were used to further refine the adapted protocol. Second, the mPCST-Community protocol was evaluated in a single-arm trial with 20 patients. The invesitgators found high feasibility (i.e., recruitment met), low attrition and high adherence (90% completion), and high acceptability. Importantly, impressive and positive pre- to post-intervention changes were found for pain severity (t=-2.52, p=0.01,gav=0.62; 30% change), pain interference (t=-2.62,p=0.01, gav=0.62), and self-efficacy for pain management (t=3.57, p=0.0004, gav=0.98; 30% change).8Study specific aims are: Aim 1:Test the extent to which mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress. Hypothesis:mPCST-Community will lead to decreases in these pain-related outcomes compared to a Health-Ed control condition. Aim 2:Examine mediators through which mPCST-Community leads to benefits. Hypothesis:The effects of mPCST-Community on pain severity, pain interference, fatigue, physical disability, and psychological distress will be mediated by increased self-efficacy for pain management and decreased pain catastrophizing. Aim 3:Evaluate the cost and cost-effectiveness of mPCST-Community. Hypothesis: mPCST-Community will be cost-saving or cost effective in terms of its incremental cost per quality-adjusted life-year from a societal perspective, inclusive of healthcare, intervention and patient-time costs. Its sustainability will be further demonstrated by documenting successful accrual, retention, and protocol adherence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
cancer, pain, fatigue, distress, coping, mHealth, symptom management, physical disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

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).
Arm Title
mHealth-Education (mHealth-Ed)
Arm Type
No Intervention
Arm Description
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health Pain Coping Skills Training (mPCST)
Intervention Description
Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
Primary Outcome Measure Information:
Title
Change in pain severity
Description
Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about worst, least, average and now pain on a 0 = no pain to 10 = pain as bad as you can imagine.
Time Frame
Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Title
Change in Pain Interference
Description
Pain Interference will be assessed by asking how much pain has interfered with seven daily activities including general activity, walking, work, mood, enjoyment of life, relations with other and sleep within the last 7 days on a 0 = does not interfere to 10 = completely interferes
Time Frame
Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Title
Change in fatigue
Description
The Patient Reported Outcomes Measurement Information System (PROMIS) six-item Fatigue Scale is a self-report measure of fatigue symptoms. Items ask patients to evaluate symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities.
Time Frame
Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Title
Change in Physical Disability
Description
Physical disability will be assessed using 4-item form Patient Care Monitor (PCM) scale. The four items ask about patients' ability to run, do light physical work or fun activities, do hard physical work or fun activities, and ability to function normally in the last 7 days (0 = not a problem to 10 = as bad as possible).
Time Frame
Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Secondary Outcome Measure Information:
Title
Change in Self-Efficacy for pain control
Description
The self-efficacy for pain management will be assessed using 5-item Chronic Pain Self-Efficacy scale. This sub-scale contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication. This item will be answered on a 10 = very uncertain to 100 = very certain scale and are averaged.
Time Frame
Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Title
Change in Pain Catastrophizing
Description
Pain catastrophizing will be assessed with the 6-item pain catastrophizing sub-scale of the Coping Strategies Questionnaire. These items ask about patients tendency to catastrophizing when faced with pain and are answered on a 0 = never to 6 = always
Time Frame
Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Title
Cost-Effectiveness
Description
We will create a composite cost variable based on patient time, medical resource use, productivity, and the EQ-5D.The EQ-5D is a measure of health status that can be linked to population-based preference weights is widely used in economic evaluations. It is short, assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The respondent indicates no problems, some problems, or severe problems in each dimension.
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with a diagnosis of any breast cancer within the last three years being >18 years old having a life expectancy of >12 months report experiencing pain on at least 10 days in the last month and rate their pain in the past week as a 4 or greater on a 0-10 scale. The combination of these items assess patients level of persistent pain (in the last month) and pain severity with an accurate recall period (i.e., last week; >4). Exclusion Criteria: cognitive impairment as indicated by a baseline Folstein Mini-Mental Status Examination of <2588 brain metastases presence of a severe psychiatric condition 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 medical/study staff interactions, or 4) current or past (<6 months) engagement in PCST for cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara J Somers, Ph.D.
Phone
919-416-3408
Email
tamara.somers@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara J Somers, Ph.D.
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara J Somers, PhD
Phone
919-416-3408

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients

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