- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02247583
Investigating Patient Satisfaction With Oral Anti-Cancer Treatment (IPSOC)
Investigating Patient Satisfaction With Oral Anti-Cancer Treatment. Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care in Patients With Advanced Renal Cell Carcinoma Treated With an Oral Anti-cancer Drug.
Prospective non-interventional non-controlled multicenter observational study to evaluate aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an oral anti-cancer drug.
The main objective of this study is to evaluate the patient perspective in the treatment of advanced renal cell carcinoma with an oral anti-cancer drug.
The following aspects will be investigated:
- Intrinsic desire for information about treatment.
- Patient satisfaction with treatment information.
- Patient satisfaction with treatment.
- Medication adherence.
- Health-related quality of life.
- The role of different health care professionals in the treatment of RCC with oral drugs
This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who are 18 years or older, and who can be contacted by phone and/or e-mail are eligible for the study
Exclusion Criteria:
- Patients who are not able to understand Dutch or French will be excluded from the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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mRCC patients
Patients with metastatic renal cell carcinoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence
Time Frame: one year
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At the first visit patients will receive their anti-cancer medication by the hospital in a pill box which electronically records openings cf.
Medication Event Monitoring System (MEMS®, Aardex).
The recorded information in this chip will be read in the hospital pharmacy each time the patient gets new capsules.
This information is strictly confidential and can only be consulted by the research team at the KULeuven.
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of Information Desire (EID)
Time Frame: one year
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Extent of information desire will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
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one year
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Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
Time Frame: one year
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Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
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one year
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Morisky Medication Adherence Scale (MMAS)
Time Frame: one year
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Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
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one year
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Cancer Therapy Satisfaction Questionnaire (CTSQ)
Time Frame: one year
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Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
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one year
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Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: one year
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Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
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one year
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Functional Kidney Symptom Index (FKSI)
Time Frame: one year
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Health-related quality of life will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
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one year
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Satisfaction With Pharmacist (SwiP)
Time Frame: one year
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Satisfaction with the pharmacist will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Veerle Foulon, Professor, Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VF/2010/03
- s52586 (Registry Identifier: Clinical Trial Center UZ Leuven)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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