Hepatocellular CarcinomaSORATELNCT02564666
The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib
A study testing telephone counseling in people with Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- telephone counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma
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.
Read more
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.
Read the 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
- Being tested
- telephone counseling
- Keywords
- hepatocellular carcinoma, sorafenib, telephone counseling
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone counselingOther
regular telephone counseling for compliance and advese event
| Study group | Role | What they receive |
|---|---|---|
| Telephone counseling | Active comparator | regular telephone counseling per week Receives: Other: telephone counseling |
| No telephone counseling | No intervention | no regular telephone counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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] )
Measured: 6 weeks
Secondary outcomes (2)
Survival rate
Measured: 12 months
Duration of dosing period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Hyun Shim, Asan Medical Center
- Investigators
- Ju Hyun Shim, MD. PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564666
- Sponsor's protocol ID
- 2015-0815
- Acronym
- SORATEL
- Status last verified
- Sep 2015
- First submitted
- 20 Aug 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02564666
- Acronym / sponsor ID
- SORATEL / 2015-0815
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, sorafenib, telephone counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone counseling | Active comparator | Other: telephone counselingregular telephone counseling per week |
| No telephone counseling | No intervention | –no regular telephone counseling |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone counselingregular telephone counseling for compliance and advese event | Other | Telephone counseling |
Primary outcome
Drug compliance for patients with HCC who is taking Sorafenib compliance
Time frame: 6 weeks
"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] )
2 secondary outcomes
Survival rate
Time frame: 12 months
Duration of dosing period
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju Hyun Shim, MD. PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone counseling in people with Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Hyun Shim, MD. PhD (82230103190, s5854@medimail.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug compliance for patients with HCC who is taking Sorafenib compliance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.