Clinical trial NCT02564666: The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib
Official title: The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
sorafenib
telephone counseling
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug compliance for patients with HCC who is taking Sorafenib compliance
timeFrame: 6 weeks
Secondary outcomes:
measure: Survival rate
timeFrame: 12 months
measure: Duration of dosing period
timeFrame: 12 months
Other outcomes:
measure: The satisfaction with Information about Medicines Scale (SIMS) score
timeFrame: 6 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Ju Hyun Shim, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: