An intervention to prevent symptoms associated with hepatitis C: a pilot study

Area of Science:

• Hepatology and Viral Hepatitis Research
• Clinical Trial Methodology
• Patient-Reported Outcomes

Background:

• Chronic hepatitis C treatment with interferon alpha and ribavirin can cause significant fatigue and impact quality of life.
• There is a need to evaluate supportive interventions to mitigate treatment side effects.
• Pilot studies are crucial for refining methodologies and estimating effect sizes for future clinical trials.

Purpose of the Study:

• To pilot test instruments for measuring fatigue and quality of life (QOL) in patients with chronic hepatitis C.
• To evaluate the feasibility of an exercise intervention for this patient population.
• To estimate the effect size of the exercise intervention on fatigue, QOL, and walking distance.

Main Methods:

• Pilot study involving 20 patients with chronic hepatitis C commencing interferon alpha and ribavirin therapy.
• Utilized the Schwartz Cancer Fatigue Scale and Hepatitis Quality of Life Questionnaire for outcome assessment.
• Employed power analyses to estimate sample size requirements for future definitive trials.

Main Results:

• The Schwartz Cancer Fatigue Scale and Hepatitis Quality of Life Questionnaire demonstrated moderate to high internal consistency (alpha reliabilities).
• Power analyses indicated a small effect size for the exercise intervention across all measured outcomes.
• A sample size of 30-40 patients per group is estimated to achieve a power of greater than 0.80 in future studies.

Conclusions:

• The chosen instruments for measuring fatigue and QOL are reliable for use in this population.
• The pilot exercise intervention demonstrated a small effect size, necessitating larger-scale trials.
• Future research should focus on adequately powered studies to confirm the efficacy of exercise interventions in chronic hepatitis C patients undergoing antiviral therapy.