# A Mobile Health Behavioral Pain Intervention Protocol for Breast Cancer Patients with Pain in Medically Underserved Communities: A Randomized Controlled Trial

> **NIH NIH R01** · DUKE UNIVERSITY · 2024 · $590,892

## Abstract

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. This innovative application proposes the first study to examine the
efficacy of mPCST-Community that is designed to address pain in cancer patients in medically underserved
areas. While improving access to care is critical, providing efficacious care is just as important. If mPCST-
Community is shown to be efficacious, it will provide an intervention that can be rapidly implemented into the
care of cancer patients with pain. Importan...

## Key facts

- **NIH application ID:** 10757396
- **Project number:** 5R01CA237892-05
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Tamara J Somers
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $590,892
- **Award type:** 5
- **Project period:** 2020-01-10 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10757396

## Citation

> US National Institutes of Health, RePORTER application 10757396, A Mobile Health Behavioral Pain Intervention Protocol for Breast Cancer Patients with Pain in Medically Underserved Communities: A Randomized Controlled Trial (5R01CA237892-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10757396. Licensed CC0.

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