Trial results for an mHealth behavioral cancer pain intervention for Breast Cancer patients were posted on ClinicalTrials.gov on 2025-12-09, with 180 participants enrolled.
Background
Breast cancer is a prevalent disease, and managing associated pain is a critical aspect of patient care, especially for those in medically underserved areas. Traditional pain management often involves pharmacological approaches, but there is a growing interest in non-pharmacological behavioral interventions. Mobile health (mHealth) technologies offer a promising avenue to deliver such interventions broadly and efficiently. This study aimed to investigate the efficacy of an mHealth behavioral cancer pain intervention, specifically Pain Coping Skills Training (mPCST), for breast cancer patients to decrease pain and disability, addressing a gap in research for this specific population.
Trial design
This completed study, designated as Phase NA, enrolled 180 participants with Breast Cancer. The trial investigated the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients in medically underserved areas. The intervention was compared against an mHealth-Education (mHealth-Ed) control group.
Key results
The trial reported key measurements for pain severity and pain interference using the Brief Pain Inventory (BPI) for both intervention groups:
- Pain Severity as Measured by the Brief Pain Inventory (BPI) (score on a scale):
- For the Mobile Health Pain Coping Skills Training (mPCST) group, mean scores were observed at 4.71 (Standard Deviation 2.05), 3.52 (Standard Deviation 2.04), 3.59 (Standard Deviation 2.37), and 3.16 (Standard Deviation 2.12).
- For the mHealth-Education (mHealth-Ed) group, mean scores were observed at 4.51 (Standard Deviation 1.84), 4.69 (Standard Deviation 2.32), 4.15 (Standard Deviation 2.40), and 4.13 (Standard Deviation 2.58).
- Pain Interference as Measured by the Brief Pain Inventory (BPI) (score on a scale):
- For the Mobile Health Pain Coping Skills Training (mPCST) group, mean scores were observed at 4.64 (Standard Deviation 2.56) and 3.28 (Standard Deviation 2.34).
- For the mHealth-Education (mHealth-Ed) group, mean scores were observed at 4.76 (Standard Deviation 2.30) and 4.79 (Standard Deviation 2.55).
What this means
The results indicate that the Mobile Health Pain Coping Skills Training (mPCST) intervention generally led to lower mean scores for both pain severity and pain interference compared to the mHealth-Education group. For pain severity, mPCST consistently showed lower mean scores across multiple measurements (e.g., 3.16 vs. 4.13). Similarly, for pain interference, mPCST also demonstrated lower mean scores (e.g., 3.28 vs. 4.79). These findings suggest that a behavioral mHealth intervention focused on pain coping skills may be more effective in reducing pain and its impact on daily life for breast cancer patients, particularly in medically underserved populations, compared to general health education delivered via mHealth.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04175639, titled "mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients", were posted on 2025-12-09 on clinicaltrials.gov.