Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Feasibility as Measured by Study Accrual
研究概览
简要总结
PainPac is innovative in its potential to integrate with healthcare systems through electronic medical records (EMRs). PainPac leverages technology to increase patient access to interventions and uses real-time assessment to improve care. PainPac is positioned to rapidly provide improved care through combining biological data (e.g., EMRs, patient collected) with behavioral data to dramatically improve outcomes. PainPac could track beneficial outcomes related to clinical pain scores (e.g., patients with scores 4-8 benefit) and intervention implementation could be based on this; a more advanced possibility is use of geospatial tracking to predict space/time where pain is likely to impact functioning and push an intervention strategy - behavioral or pharmacological. PainPac is designed for future transmission of data to EMRs to inform providers of patient status. This work will provide data to bypass traditional efficacy trials and move quickly to a large effectiveness trial.
详细描述
The investigators will use a pilot RCT to examine PainPac feasibility, patient burden, engagement, acceptability, and initial pain-related outcomes, compared to a therapist led videoconference delivered behavioral pain intervention (PCST-Video) in colorectal cancer patients with pain. Investigators will use quantitative and qualitative data to optimize PainPac. Participants will complete assessments at pre-treatment (A1), post-treatment (A2; 4 weeks post-A1), and 1 month follow-up (A3; 1 month post-A2) (months 5-22). The pain management strategies are relevant and efficacious across cancer types. Due to the pilot nature of this work, investigators will enroll an opportunity sample of colorectal cancer patients.
PainPac is a patient-focused intervention developed using cognitive-behavioral theory and empirically supported strategies to enhance patients' ability to manage their pain. PainPac is a mobile app available to participants on a smartphone or tablet. PainPac uses Social Cognitive Theory to promote behaviors to improve pain, self-efficacy for pain management, and pain-related quality of life indices. It also uses real-time data to personalize the intervention and messaging to participants. PainPac contains 4 modules, each including a skill that has shown efficacy for reducing pain in patients with cancer. Patients are prompted to complete one module each week for 4 weeks. The app also has interactive components to improve coping skills engagement.
Participants randomized to PCST-Video will receive 4 behavioral cancer pain intervention sessions delivered by videoconferencing by a pain therapist in the medical center to the patient in their natural environment (e.g., home). Sessions will be scheduled weekly for 45-60 min and mimic in person sessions. PCST-Video session content is matches the PainPac skills modules described above. PCST-Video participants will complete assessments at the same intervals as PainPac participants.
Aim 1: Test whether PainPac is feasible (primary aim), low burden, engaging, and acceptable.
Aim 2: Examine the impact of PainPac on pain severity, pain interference, pain self-efficacy, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage I-IV Colorectal Cancer diagnosis
- •18 years of age or older
排除标准
- •Cognitive Impairment
- •Brain Metastases
- •Severe psychiatric condition (e.g., psychosis) that would contraindicate safe participation
- •Participation in behavioral pain management in the past 6 months.
结局指标
主要结局
Feasibility as Measured by Study Accrual
时间窗: Baseline
Reaching target accrual (N=60) within 15 months.
Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit)
时间窗: 1-month follow-up (9-12 weeks post-baseline)
Feasibility as Measured by the Number of Participants Who Completed Study Baseline Assessments
时间窗: Baseline
Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the study baseline assessment.
Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments
时间窗: Post-treatment assessment (5-8 weeks post-baseline)
Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the post-study sessions assessment.
Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed
时间窗: 1-month follow-up (9-12 weeks post-baseline)
Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the 1-month follow up assessment.
Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions
时间窗: 5-8 weeks post-baseline
Includes protocol adherence indicated by calculating the degree to which participants are willing/able to complete the 4 PainPac skills modules or 4 PCST-Video sessions.
Feasibility as Measured by Study Accrual
时间窗: Baseline
Reaching target accrual (N=60) within 15 months.
Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit)
时间窗: 1-month follow-up (9-12 weeks post-baseline)
Feasibility as Measured by the Number of Participants Who Completed Study Baseline Assessments
时间窗: Baseline
Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the study baseline assessment.
Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments
时间窗: Post-treatment assessment (5-8 weeks post-baseline)
Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the post-study sessions assessment.
Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed
时间窗: 1-month follow-up (9-12 weeks post-baseline)
Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the 1-month follow up assessment.
Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions
时间窗: 5-8 weeks post-baseline
Includes protocol adherence indicated by calculating the degree to which participants are willing/able to complete the 4 PainPac skills modules or 4 PCST-Video sessions.
次要结局
- Change in Quality of Life(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention)(0-2 weeks post-baseline)
- Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention)(3-8 weeks from Session 1)
- Engagement in Study(5-8 weeks post-baseline)
- Change in PROMIS - Emotional Distress (Depression) Short Form(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Acceptability as Measured by the Client Satisfaction Questionnaire.(Post-treatment assessment (5-8 weeks post-baseline))
- Acceptability as Measured by Atkinson's Tool of mHealth Innovations.(Post-treatment assessment (5-8 weeks post-baseline))
- Computer Self-Efficacy(Post-treatment assessment (5-8 weeks post-baseline))
- Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Change in Pain Self-Efficacy for Pain Management(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Acceptability as Measured by the Client Satisfaction Questionnaire.(Post-treatment assessment (5-8 weeks post-baseline))
- Acceptability as Measured by Atkinson's Tool of mHealth Innovations.(Post-treatment assessment (5-8 weeks post-baseline))
- Computer Self-Efficacy(Post-treatment assessment (5-8 weeks post-baseline))
- Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Change in Pain Self-Efficacy for Pain Management(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Burden as Measured by # of Sessions Completed(3-8 weeks post-baseline)
- Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention)(0-2 weeks post-baseline)
- Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention)(3-8 weeks from Session 1)
- Engagement in Study(5-8 weeks post-baseline)
- Change in Quality of Life(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))
- Change in PROMIS - Emotional Distress (Depression) Short Form(Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline))