Investigating Patient Satisfaction With Oral Anti-Cancer Treatment

Completed

• Conditions: Clear Cell Renal Cell Carcinoma

• Registration Number: NCT02247583
• Lead Sponsor: KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-07-03
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-19
• Last Update Submitted: 2014-09-19
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication adherence	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.

Secondary Outcome Measures

Name	Time	Method
Cancer Therapy Satisfaction Questionnaire (CTSQ)	one year	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).
Extent of Information Desire (EID)	one year	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).
Morisky Medication Adherence Scale (MMAS)	one year	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).
Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)	one year	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).
Functional Assessment of Cancer Therapy - General (FACT-G)	one year	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).
Functional Kidney Symptom Index (FKSI)	one year	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).
Satisfaction With Pharmacist (SwiP)	one year	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).

Trial Locations

Locations (1)

Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie; 🇧🇪 Leuven, Belgium