Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT04462302
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Internet-based Program to Help Cancer Survivors Manage Pain
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Internet-delivered Management of Pain Among Cancer Treatment Survivors
Status:
RECRUITING
Status Verified Date:
2025-10
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:
IMPACTS
Brief Summary:
To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.
Detailed Description:
This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 250 participants will be enrolled (125 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.
Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).
Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3UG1CA189824-06S1 | NIH | None | https://reporter.nih.gov/quic… | View |
| WF-1901 | OTHER | Wake Forest NCORP Research Base | View | |
| NCI-2020-02315 | REGISTRY | NCI CTRP (Clinical Trial Reporting Program) | View |