Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02564666
Acronym
SORATEL
Enrollment
64
Registered
2015-10-01
Start date
2015-10-31
Completion date
2017-12-31
Last updated
2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, sorafenib, telephone counseling

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.

Interventions

OTHERtelephone counseling

regular telephone counseling for compliance and advese event

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Drug compliance for patients with HCC who is taking Sorafenib compliance6 weeksDrug 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 \[low adherence\] )

Secondary

MeasureTime frame
Survival rate12 months
Duration of dosing period12 months

Other

MeasureTime frameDescription
The satisfaction with Information about Medicines Scale (SIMS) score6 weeksSIMS is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib

Countries

South Korea

Contacts

Primary ContactJu Hyun Shim, MD. PhD
s5854@medimail.co.kr82230103190
Backup ContactJin-A Park
pred1054@naver.com82230101334

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026