A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Mobile Health Pain Coping Skills Training (mPCST)
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).
干预措施: Device: smartphone (Behavioral)
结局指标
主要结局
Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
时间窗: Baseline and post intervention, approximately 60 minutes
Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)
时间窗: Baseline and Post Intervention, approximately 60 minutes
次要结局
- 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.(Baseline and Post Intervention, approximately 60 minutes)
- Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire.(Baseline and Post Intervention, approximately 60 minutes)
- Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms.(Baseline and Post Intervention, approximately 60 minutes)
- Change in mPCST Acceptability, as measured by participants' engagement(Sessions 2,3,4 and 5)
- change in Health-Related Quality of Life(Baseline and Post Intervention, approximately 60 minutes)
- Change in fatigue(Baseline and Post Intervention, approximately 60 minutes)