Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03057236
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2017-02-15
Brief Title:
Pilot Feasibility Study of a Cognitive Behavioral Coping Skills CBCS Group Intervention for Hep C Therapy Patients
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
A Pilot Feasibility Study of a Cognitive Behavioral Coping Skills CBCS Group Intervention for Patients Undergoing Antiviral Therapy for Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2017-02
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:
This is a pilot feasibility study of a small randomized controlled trial RCTdesign to evaluate participation in a Cognitive Behavioral Coping Skills CBCS group intervention versus standard of care in patients with hepatitis C undergoing antiviral treatment The primary objectives are to 1 examine effect size ES estimates of key outcomes to provide essential data to inform a larger efficacy trial 2 determine whether clinically significant improvements occurred in any key outcomes and 3 evaluate study feasibility and patient acceptability Study findings will inform a larger efficacy study of the CBCS-HCV
Detailed Description:
This is a pilot feasibility study of a Cognitive Behavioral Coping Skills CBCS Group Intervention with a representative sample of patients with Hepatitis C viral HCVundergoing standard antiviral treatment in a small RCT to examine 1 study feasibility 2 effect size estimates and 3 whether clinically significant improvements occurred in key outcomes This pilot study will allow the investigators to test the hypotheses that the study procedures are feasible and that participation in the CBCS-HCV group is acceptable and useful to participants Furthermore effect size estimates of key outcome variables will determine which outcomes appear to improve as a result of the intervention and should potentially be evaluated in a future efficacy study Several patient-reported outcomes PROs are evaluated health-related quality of life HrQOL perceived stress depression anxiety anger fatigue sleep pain and medication adherence The investigators will also determine if group participation affects viral cure rate Change scores that have an effect size d 35 are considered potentially clinically significant and reasonable to evaluate in a larger efficacy study Study feasibility elements evaluated included feasibility of a RCT study design intervention delivery patient acceptability therapist protocol fidelity recruitment enrollment attendance retention and data collection
The investigators planned to enroll and evaluate the intervention in two waves of study participants Wave 2 Wave 3 When a block of 12 patients is consented for Wave 2 participants will be randomized to standard of care SC n6 or the CBCS-HCV group intervention n6 The same procedure will be used to consent and randomize 12 patients in Wave 3 to SC vs CBCS-HCV Patients randomized to CBCS will participate in 4 weekly CBCS sessions prior to starting HCV treatment and 5 more sessions during HCV treatment on the same day they attend follow-up treatment visits at weeks 2 4 6 8 and 12 Outcome data will be collected at baseline T1 just prior to HCV treatment starting T2 at week 8 of HCV treatment T3 at end of CBCS intervention HCV treatment at week 12 T4 and 1-month post-CBCS intervention HCV treatment T5 The primary outcome is change in total HrQOL score Secondary outcomes are change in other PROs noted above Additional secondary outcomes are group differences in medication adherence and viral cure rate Elements of study feasibility are also evaluated
The investigators planned to enroll and evaluate the intervention in two waves of study participants Wave 2 Wave 3 When a block of 12 patients is consented for Wave 2 participants will be randomized to standard of care SC n6 or the CBCS-HCV group intervention n6 The same procedure will be used to consent and randomize 12 patients in Wave 3 to SC vs CBCS-HCV Patients randomized to CBCS will participate in 4 weekly CBCS sessions prior to starting HCV treatment and 5 more sessions during HCV treatment on the same day they attend follow-up treatment visits at weeks 2 4 6 8 and 12 Outcome data will be collected at baseline T1 just prior to HCV treatment starting T2 at week 8 of HCV treatment T3 at end of CBCS intervention HCV treatment at week 12 T4 and 1-month post-CBCS intervention HCV treatment T5 The primary outcome is change in total HrQOL score Secondary outcomes are change in other PROs noted above Additional secondary outcomes are group differences in medication adherence and viral cure rate Elements of study feasibility are also evaluated
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 |
|---|---|---|---|
| K23DK089004 | NIH | None | None |
| K24DK066144 | NIH | None | httpsreporternihgovquickSearchK24DK066144 |