According to the NIH State-of-the-Science consensus statement, the three most frequently reported and undertreated cancer-related symptoms are pain, fatigue, and depression. Cognitive behavioral interventions have been shown to be effective in the treatment of cancer-related symptoms using traditional delivery strategies (face to face and telephone) by our team as well as others. People who are treated at our tertiary cancer center for unresectable hepatocellular carcinoma (HCC) travel across country for treatment. The treatment for HCC, chemoembolization or Yttrium-90, is infrequent, (every 8 weeks) and brief (24 hour hospitalization). As a result, assessment of cancer-related symptoms, and delivery of evidence based interventions, becomes challenging. We have demonstrated that, with limited contact with patients (3 face to face and 2 telephone sessions) we can reduce symptoms of depression and anxiety and improve some domains of health-related quality of life with evidence based interventions. However, to increase our contact with patients diagnosed with HCC, and further reduce cancer-related symptoms, we are proposing the use of new technologies, a Comprehensive Electronic Cancer Support System (CECSS). The CECSS is a website designed to facilitate reporting of symptoms by patients and enhance our opportunities to deliver evidence- based interventions through multiple mediums.
The specific aims of the study are: (1) To finalize the development of the CECSS;(2) To test the feasibility of the CECSS with people diagnosed with HCC;(3) To examine the efficacy of the CECSS in a prospective randomized controlled trial of people diagnosed with HCC.
For Aim 1, the content for the CECSS will be placed on the website, activated, and then tested by the research team.
For Aim 2, a sample of 20 people diagnosed with HCC will be recruited to test the feasibility of the CECSS.
Aim 3 will be accomplished by recruiting 256 participants diagnosed with HCC and randomly assigning them to either the intervention arm of the study (CECSS) or the standard of care arm. The efficacy of the CECSS will be evaluated using patient-reported outcomes, proxy rated outcomes, measures of health care utilization, and biological markers (e.g., alfa fetoprotein, survival) at baseline (prior to treatment) and 3-, 6-, and 9-months follow-up. The results of this study are expected to contribute to our understanding of the efficacy of the CECSS and improve the quality of life for people diagnosed with HCC.
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