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

Hepatocellular Carcinoma Clinical Trial

— SORATEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02564666
• Other study ID #: 2015-0815
• Status: Not yet recruiting
• Phase: N/A
• First received: August 20, 2015
• Last updated: September 29, 2015
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Asan Medical Center
• Contact: Ju Hyun Shim, MD. PhD
• Phone: 82230103190
• Email: s5854[@]medimail.co.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• telephone counseling
regular telephone counseling for compliance and advese event

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The satisfaction with Information about Medicines Scale (SIMS) score	SIMS is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib	6 weeks	No
Primary	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	No
Secondary	Survival rate		12 months	No
Secondary	Duration of dosing period		12 months	No