Abstract
BackgroundPatients 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.MethodsA 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.ResultsSeveral 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.ConclusionsThe 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 registrationNCT03057236 Retrospectively registered.
Highlights
Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects
To achieve our second objective, we focused on effect size (ES) estimates from baseline (T1) to the start of HCV treatment (T2), which aligned with receipt of four out of the nine CBCS-HCV sessions to determine the impact of half of the intervention on patient-reported outcomes (PROs) prior to HCV treatment initiation
Study feasibility measures Similar to the protocol implemented in wave 1 pilot testing, we evaluated the feasibility of the following study elements: (a) feasibility of randomization based on the ability to randomize and enroll a block of 12 participants; (b) recruitment and enrollment efforts as evidenced by the proportion of patients screened, consented, and enrolled; (c) retention efforts based on the number of CBCS-HCV sessions attended and the proportion of patients who started
Summary
Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects. 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. Patients complain of several diffuse symptoms that may be associated with HCV and report poor health-related quality of life (HRQOL) [3, 4]. Despite the availability of more tolerable and effective treatments, there remains a substantial need to develop psychosocial interventions to improve the health and well-being of the underserved HCV population [6]. Psychosocial interventions could enhance patients’ coping skills to mitigate the negative impact of disease, and treatment in patients have difficulty coping with treatment side effects. PROMs are often the best method for evaluating clinical improvements in mental and physical health outcomes in other medical populations but are used less often in clinical hepatology studies [8]
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