Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541990
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Psychoeducational Intervention for Patients With Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HARMONY A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma
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:
HARMONY
Brief Summary:
This study aims to refine and pilot test HARMONY a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma HCC
Detailed Description:
There are two parts of this study Study Part 1 is an open pilot study to refine HARMONY prior to larger-scale testing in a randomized controlled trial RCT setting Study Part 1 is purely descriptive as the investigators will use the data to refine HARMONY before proceeding to Study Part 2
Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care a supportive care resource guide This record reflects the clinical trial component Study Part 2 as feasibility and acceptability outcomes will be collected for this phase only
Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care a supportive care resource guide This record reflects the clinical trial component Study Part 2 as feasibility and acceptability outcomes will be collected for this phase only
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