Investigating Patient Satisfaction With Oral Anti-Cancer Treatment

NCT02247583 | Completed

• 2 other identifiers: VF/2010/03s52586
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Extent of Information Desire (EID)

  one year

• Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)

  one year

• Morisky Medication Adherence Scale (MMAS)

  one year

• Cancer Therapy Satisfaction Questionnaire (CTSQ)

  one year

• Functional Assessment of Cancer Therapy - General (FACT-G)

  one year

Study Arms (1)

mRCC patients

Patients with metastatic renal cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

mRCC patients starting with an oral anti-cancer treatment

You may qualify if:

• Patients who are 18 years or older, and who can be contacted by phone and/or e-mail are eligible for the study

You may not qualify if:

• Patients who are not able to understand Dutch or French will be excluded from the study

Sponsors & Collaborators

• KU Leuven: lead
• Flemish League Against Cancer: collaborator
• Pfizer: collaborator
• Novartis: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Veerle Foulon, Professor

  Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: September 25, 2014
• Study Start: February 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

BE (1)