N/A
N=177
mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04175639 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Pain Severity as Measured by the Brief Pain Inventory (BPI) — 4.71; 4.51; 3.52; 4.69 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mobile Health Pain Coping Skills Training (mPCST) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Severity as Measured by the Brief Pain Inventory (BPI) |
4.71; 4.51; 3.52; 4.69; 3.59; 4.15 | — |
| PRIMARY Pain Interference as Measured by the Brief Pain Inventory (BPI) |
4.64; 4.76; 3.28; 4.79; 3.22; 4.11 | — |
| PRIMARY Change in Fatigue |
60.60; 60.59; 56.38; 58.95; 56.34; 58.02 | — |
| PRIMARY Physical Disability as Measured by the Patient Care Monitor (PCM) |
5.56; 5.87; 4.62; 5.64; 4.66; 5.29 | — |
| SECONDARY Self-Efficacy for Pain Control as Measured by the Chronic Pain Self-Efficacy Scale |
54.69; 56.09; 64.46; 55.12; 65.27; 56.60 | — |
| SECONDARY Pain Catastrophizing as Measured by the Coping Strategies Questionnaire |
1.67; 1.83; 1.22; 1.60; 1.12; 1.53 | — |
| SECONDARY Cost-Effectiveness |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04175639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.