Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555588
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Engage Psychosocial Intervention for Cancer Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Engage A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Engage
Brief Summary:
The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast prostate lung or colorectal cancer Participants will be randomized to ENGAGE or a Supportive Care intervention Patient-reported outcomes will be assessed at baseline 2 months and 4 months
Detailed Description:
Pain fatigue and distress are highly prevalent co-occurring and interfering symptoms in patients with advanced cancer This trial will test a brief telehealth delivered psychosocial intervention called ENGAGE ENGAGE aims to help patients decrease symptom interference and improve their quality of life Patients with Stage IV cancer breast prostate lung or colorectal and moderate-to-severe symptom interference will be randomized to ENGAGE or Supportive Care Patient-reported outcomes will be assessed at baseline 2 months and 4 months Aim 1 is to determine ENGAGEs efficacy for reducing symptom interference primary outcome at 2 months primary endpoint Aim 2 is to determine ENGAGEs efficacy for improving secondary outcomes at 2 months Aim 3 is to test the maintenance of ENGAGEs effects on primary and secondary outcomes at 4 months An exploratory aim seeks insights for future implementation efforts using mixed-methods data collection from patients oncology providers and clinic leaders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None