The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Drug compliance for patients with HCC who is taking Sorafenib compliance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Drug compliance for patients with HCC who is taking Sorafenib compliance
时间窗: 6 weeks
"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 \[low adherence\] )
次要结局
- Survival rate(12 months)
- Duration of dosing period(12 months)