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

NCT ID: NCT02564666

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Telephone counseling

regular telephone counseling per week

Group Type: ACTIVE_COMPARATOR

telephone counseling

Intervention Type: OTHER

regular telephone counseling for compliance and advese event

No telephone counseling

no regular telephone counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telephone counseling

regular telephone counseling for compliance and advese event

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ju Hyun Shim

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ju Hyun Shim, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Central Contacts

Ju Hyun Shim, MD. PhD

Role: CONTACT

s5854@medimail.co.kr

82230103190

Jin-A Park

Role: CONTACT

pred1054@naver.com

82230101334

Other Identifiers

2015-0815

Identifier Type: -

Identifier Source: org_study_id