Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C

Abstract

Background: Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects. The Cognitive Behavioral Coping Skills group intervention for HCV (CBCS-HCV) was developed using the Stage Model of Behavioral Therapies Research. Intervention development and initial feasibility testing in wave 1 participants were previously reported. The primary objective of this subsequent pilot with wave 2-3 participants was to investigate the effect sizes and clinical improvements in patient-reported outcomes (PROs) and trial and intervention feasibility.

Methods: A pilot feasibility two-arm randomized controlled trial using block randomization to assign patients to CBCS-HCV or standard of care was conducted. Participants attended nine group sessions: four before HCV treatment and five during treatment. PRO data were collected at five time points: before the CBCS intervention (T1), immediately before HCV treatment (T2), during HCV treatment (T3, T4), and 1 month post-intervention/post-HCV treatment (T5). PROs included quality of life, perceived stress, HCV symptoms, and medication adherence. Cohen's d was used to estimate within-group changes (WGCs) and between-group differences (BGDs), with d > 0.35 considered potentially clinically significant. Potential mechanisms of change were also evaluated.

Results: Several WGCs and BGDs (ES > .35) suggest that the CBCS-HCV may promote improvements in PROs: psychological stress, depression, anger, anxiety, sleep disturbance, and fatigue. The intervention did not appear to impact social functioning, pain, or medication adherence. Cognitive behavioral skills and group therapy dynamics, but not HCV treatment self-efficacy, may mediate improvements in PROs. Most aspects of the study trial, including intervention implementation, were feasible. Patient acceptance and retention were exceptional. The greatest feasibility challenge was due to patients needing to initiate treatment as soon as medications were obtained, but often before a full block could be created in wave 3. Challenges with PRO data collection were identified that will be resolved in future studies.

Conclusions: The CBCS-HCV intervention warrants future investigation in an efficacy trial to evaluate improvements in selected PROs. The next step is to pilot test the CBCS-HCV delivered via telehealth to an expanded pool of patients to reduce patient barriers, hone technical logistics, and improve intervention reach and effectiveness.

Trial registration: NCT03057236 Retrospectively registered.

Keywords: Antiviral therapy; Direct-acting antiviral; Liver disease; Patient-reported outcome measures; Psychological; Quality of life; Stress; Symptoms.

Conflict of interest statement

This study was approved by the University of North Carolina at Chapel Hill’s Institutional Review Board (IRB# 12-2323). All study participants provided written consent to participate in the study prior to data collection.Donna Evon has served as an ad hoc consultant and receives grant support from Gilead. Michael Fried has received research funding from and served as a consultant for AbbVie, BMS, Gilead, and Merck. He serves as consultant to TARGET PharmaSolutions. The remaining authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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PROMIS depression

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PROMIS anger

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PROMIS anxiety

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PROMIS sleep disturbance

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PROMIS sleep-related impairment

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PROMIS fatigue

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PROMIS pain intensity

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PROMIS pain interference

Fig. 9

Study flowchart. Note: two participants withdrew after randomization and baseline due to transportation issues and delays in treatment. Period of time in which both the CBCS-HCV and SC groups received HCV treatment. Period of time in which only the CBCS-HCV received the CBCS intervention. Intervention group. Standard of care group. Measurement time points