Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05686122
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-01-06
Brief Title:
Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings PainPac
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg EMRs patient collected with behavioral data to dramatically improve outcomes PainPac could track beneficial outcomes related to clinical pain scores eg 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 spacetime 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
Detailed 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21CA273832 | NIH | None | httpsreporternihgovquickSearch1R21CA273832 |