mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients

NCT04175639 | Completed Results

• 1 other identifier: Pro00103527
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

cancer; pain; fatigue; distress; coping; mHealth; symptom management; physical disability

Outcome Measures

Primary Outcomes (4)

• Pain Severity as Measured by the Brief Pain Inventory (BPI)

  Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about pain on a scale of 0 = no pain to 10 = pain as bad as you can imagine.

  Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

• Pain Interference as Measured by the Brief Pain Inventory (BPI)

  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 scale of 0 = does not interfere to 10 = completely interferes. Reported as the mean score for the seven items.

  Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

• 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. Reported as a T-score with a range of 0 to 100, with a mean score of 50 and a standard deviation of 10. A higher score indicates greater fatigue.

  Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

• Physical Disability as Measured by the Patient Care Monitor (PCM)

  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). Reported as the mean score for the four items.

  Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

Secondary Outcomes (3)

• Self-Efficacy for Pain Control as Measured by the Chronic Pain Self-Efficacy Scale

  Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

• Pain Catastrophizing as Measured by the Coping Strategies Questionnaire

  Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

• Cost-Effectiveness

  Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time

Study Arms (2)

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: Mobile Health Pain Coping Skills Training (mPCST)

mHealth-Education (mHealth-Ed)

NO INTERVENTION

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.

Interventions

Mobile Health Pain Coping Skills Training (mPCST) BEHAVIORAL

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.

Mobile Health Pain Coping Skills Training (mPCST)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Pain; Fatigue

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Tamara Somers, PhD
• Organization: Duke University School of Medicine

tamara.somers@duke.edu

919-416-3408

Study Officials

• Tamara J Somers, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: October 20, 2021
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)