The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib

Study Overview
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Brief Summary
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Sorafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects used as systemic treatment in patients with unresectable hepatocellular carcinoma. Although sorafenib has demonstrated many clinical benefits in patients, its adverse cannot be ignores. This drug occasionally causes severe adverse events (AEs), which include hand-foot skin reaction (HFSR), hypertension, diarrhea, anorexia, fatigue, weight loss, and so on. Although most adverse events are reversible, they can significantly impact a patient's quality of life and occasionally result in dose reduction or discontinuation of therapy Patients are also more likely to remain on treatment if they are guided over the difficult initial 4 6wks of therapy during which time the development of adverse events following sorafenib treatment initiation are most likely to occur. Patient education, proactive management and establishing and maintaining open communication between patients and the nurse are crucial to the effective management of these adverse events. This study design is a randomized controlled trial and 64 patients will be randomized to one of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the rest of 32 patients will be enrolled into the intervention group. The intervention group will be received the routine telephone calls of six times at intervals of once a week during 10 15 minutes (from a well-trained nurse) The purpose of this study is to confirm whether an effective intervention that telephone counseling and education by a nurse can increase drug compliance for patients with HCC who is taking Sorafenib and is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib after investigating patient satisfaction by The Satisfaction with information about Medicines Scale(SIMS) tool.

Detailed Description
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This study design is a randomized controlled trial and 64 patients will be randomized to one of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the rest of 32 patients will be enrolled into the intervention group. The intervention group will be received the routine telephone calls of six times at intervals of once a week during 10 15 minutes (from a well-trained nurse) The purpose of this study is to confirm whether an effective intervention that telephone counseling and education by a nurse can increase drug compliance for patients with HCC who is taking Sorafenib and is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib after investigating patient satisfaction by The Satisfaction with information about Medicines Scale(SIMS) tool.

Official Title
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The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Other: telephone counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who agrees voluntarily Patient with a diagnosis of HCC is receiving Sorafenib monotherapy. Child-Pugh class, A or B, ECOG PS 0 2 20 years of age or older. Patient who can listen and speak Korean Exclusion Criteria: lack of cognitive ability or any r psychiatric illness Patient who is receiving combination treatment of TACE or other HCC treatment with Sorafenib. A hearing-impaired patient. Patient who has accompanied other primary malignants tumor in other organs except for HCC.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telephone counseling<br>regular telephone counseling per week | Other: telephone counseling<br>* regular telephone counseling for compliance and advese event<br>|
| No Intervention: No telephone counseling<br>no regular telephone counseling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug compliance for patients with HCC who is taking Sorafenib compliance | Drug compliance for patients with HCC who is taking Sorafenib as Assessed by MMAS-8 Score and compare MMAS-8 score between control group and intervention group. Measurement is Scores range from 0 [high adherence] to 3 8 [low adherence] ) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 12 months | 
| Duration of dosing period |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, sorafenib, telephone counseling