Clinical trial · Interventional
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Device: smartphone | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mobile Health Pain Coping Skills Training (mPCST)
- description
- 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).
- interventionNames
- Behavioral: Device: smartphone
Primary outcomes (2)
- measure
- Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
- timeFrame
- Baseline and post intervention, approximately 60 minutes
- measure
- Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)
- timeFrame
- Baseline and Post Intervention, approximately 60 minutes
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available