Investigating Patient Satisfaction With Oral Anti-Cancer Treatment

Clear Cell Renal Cell Carcinoma Clinical Trial

— IPSOC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247583
• Other study ID #: VF/2010/03
• Secondary ID: s52586
• Status: Completed
• Phase: N/A
• First received: July 3, 2014
• Last updated: September 19, 2014
• Start date: February 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie	Leuven

Sponsors (5)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Flemish League Against Cancer, GlaxoSmithKline, Novartis, Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	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).	one year	No
Secondary	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).	one year	No
Secondary	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).	one year	No
Secondary	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).	one year	No
Secondary	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).	one year	No
Secondary	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).	one year	No
Secondary	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).	one year	No