Clear Cell Renal Cell CarcinomaIPSOCNCT02247583
Investigating Patient Satisfaction With Oral Anti-Cancer Treatment
An observational study of Clear Cell Renal Cell Carcinoma, run by KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2011to Jul 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mRCC patients starting with an oral anti-cancer treatment
Who may be able to join
- Patients who are 18 years or older, and who can be contacted by phone and/or e-mail are eligible for the study
Who cannot join
- Patients who are not able to understand Dutch or French will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
Leuven, 3000
About this study
Official title: 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.
Read more
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.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mRCC patients | Patients with metastatic renal cell carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
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.
Measured: one year
Secondary outcomes (7)
Extent of Information Desire (EID)
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).
Measured: one year
Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
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).
Measured: one year
Morisky Medication Adherence Scale (MMAS)
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).
Measured: one year
Cancer Therapy Satisfaction Questionnaire (CTSQ)
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).
Measured: one year
Functional Assessment of Cancer Therapy - General (FACT-G)
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).
Measured: one year
Functional Kidney Symptom Index (FKSI)
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).
Measured: one year
Satisfaction With Pharmacist (SwiP)
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).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startFeb 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish League Against Cancer, Pfizer, Novartis, GlaxoSmithKline
- Responsible party
- Principal investigator, Sandra De Coster, KU Leuven
- Investigators
- Veerle Foulon, Professor, Study director, Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247583
- Sponsor's protocol ID
- VF/2010/03
- Other IDs
- s52586
- Acronym
- IPSOC
- Status last verified
- Sep 2014
- First submitted
- 3 Jul 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02247583
- Acronym / sponsor ID
- IPSOC / VF/2010/03
- Conditions
- Clear Cell Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Flemish League Against Cancer, Pfizer, Novartis, GlaxoSmithKline
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Sep 2014 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRCC patients | – | –Patients with metastatic renal cell carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mRCC patients starting with an oral anti-cancer treatment
Key inclusion criteria (1 listed)
- Patients who are 18 years or older, and who can be contacted by phone and/or e-mail are eligible for the study
Key exclusion criteria (1 listed)
- Patients who are not able to understand Dutch or French will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication adherence
Time frame: one year
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.
7 secondary outcomes
Extent of Information Desire (EID)
Time frame: one year
Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
Time frame: one year
Morisky Medication Adherence Scale (MMAS)
Time frame: one year
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Time frame: one year
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: one year
Functional Kidney Symptom Index (FKSI)
Time frame: one year
Satisfaction With Pharmacist (SwiP)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
Related trials for Clear Cell Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Active, not recruitingPhase 1/2
Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Renal Cell Carcinoma
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.
Veerle Foulon, Professor study director
Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clear Cell Renal Cell Carcinoma, run by KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Sep 2014. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: one year). 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 25 Sep 2014.