--- title: A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities nct_id: NCT02783755 overall_status: COMPLETED phase: NA sponsor: Duke University study_type: INTERVENTIONAL primary_condition: Breast Cancer countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02783755.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02783755" ct_last_update_post_date: 2019-08-19 last_seen_at: "2026-05-12T06:45:05.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities **Official Title:** A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities. **NCT ID:** [NCT02783755](https://clinicaltrials.gov/study/NCT02783755) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 20 - **Lead Sponsor:** Duke University - **Conditions:** Breast Cancer - **Start Date:** 2016-05 - **Completion Date:** 2017-06-30 - **CT.gov Last Update:** 2019-08-19 ## Brief Summary The purpose of this study is two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone components with the assistance of experts in the field. Next, an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mPCST protocol and basic smart phone components. The protocol-designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas-will be delivered via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g., simple text messages, images, and preloaded intervention content) will allow the intervention to extend into the patients' homes. The second study purpose is to pilot test the feasibility, acceptability, and efficacy of the developed protocol. The investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus group data will be managed and evaluated in a systematic format using a grounded theory approach. Data analyses for the pilot testing period of the study will be assessed by examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest. There are minimal risk or safety issues related to this study. ## Eligibility - **Minimum age:** 21 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` Inclusion Criteria: * diagnosis of breast cancer within the last three years * being \>21 years old, * having a life expectancy of at least 12 months, * having 1 clinical pain ratings of \>3 gathered as part of their routine clinic visits Exclusion Criteria: * metastases to the brain, * presence of a severe psychiatric condition (i.e., psychotic disorder or episode) 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 interactions with the medical/study staff, * current or past (\<6 months) engagement in PCST for cancer. ``` ## Arms - **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). ## Interventions - **Device: smartphone** (BEHAVIORAL) — Coping Skills Training for pain will be delivered to participants using video-conferencing ## Primary Outcomes - **Change in pain severity will be assessed with the Brief Pain Inventory (BPI).** _(time frame: Baseline and post intervention, approximately 60 minutes)_ - **Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)** _(time frame: Baseline and Post Intervention, approximately 60 minutes)_ ## Secondary Outcomes - **Change in self-efficacy for pain control will be assessed with the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale.** _(time frame: Baseline and Post Intervention, approximately 60 minutes)_ - **Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire.** _(time frame: Baseline and Post Intervention, approximately 60 minutes)_ - **Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms.** _(time frame: Baseline and Post Intervention, approximately 60 minutes)_ - **Change in fatigue** _(time frame: Baseline and Post Intervention, approximately 60 minutes)_ - **Change in mPCST Acceptability, as measured by participants' engagement** _(time frame: Sessions 2,3,4 and 5)_ - **change in Health-Related Quality of Life** _(time frame: Baseline and Post Intervention, approximately 60 minutes)_ ## Locations (1) - Duke University Medical Center, Durham, North Carolina, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.duke university medical center|durham|north carolina|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02783755.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02783755* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*