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Clinical Trial Summary

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.


Clinical Trial Description

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. Aim 3: Gather quantitative and qualitative post-treatment data on patients' preferences, barriers, and facilitators regarding PainPac to update and optimize PainPac for a future large randomized clinical effectiveness trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05686122
Study type Interventional
Source Duke University
Contact Sarah A Kelleher, PhD
Phone 919-416-3405
Email sarah.kelleher@duke.edu
Status Not yet recruiting
Phase N/A
Start date April 1, 2023
Completion date March 31, 2025

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