Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-20 @ 4:41 AM
Study NCT ID:
NCT02564666
Status:
UNKNOWN
Last Update Posted:
2015-10-01
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SORATEL
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: