The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib
SORATEL
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 1, 2015
September 1, 2015
1.2 years
August 20, 2015
September 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Survival rate
12 months
Duration of dosing period
12 months
Other Outcomes (1)
The satisfaction with Information about Medicines Scale (SIMS) score
6 weeks
Study Arms (2)
Telephone counseling
ACTIVE COMPARATORregular telephone counseling per week
No telephone counseling
NO INTERVENTIONno regular telephone counseling
Interventions
regular telephone counseling for compliance and advese event
Eligibility Criteria
You may qualify if:
- Patient who agrees voluntarily
- Patient with a diagnosis of HCC is receiving Sorafenib monotherapy.
- Child-Pugh class, A or B, ECOG PS 0\~2
- years of age or older.
- Patient who can listen and speak Korean
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ju Hyun Shim, MD. PhD
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
August 20, 2015
First Posted
October 1, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
October 1, 2015
Record last verified: 2015-09