Clinical Trial: Investigating Patient Satisfaction With Oral Anti-Cancer Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Katholieke Universiteit Leuven

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Extent of Information Desire (EID) [ Time Frame: 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).
  • Patient Satisfaction with Cancer Treatment Education (Ps-CaTE) [ Time Frame: 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).
  • Morisky Medication Adherence Scale (MMAS) [ Time Frame: 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).
  • Cancer Therapy Satisfaction Questionnaire (CTSQ) [ Time Frame: 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).
  • Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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).


Original Secondary Outcome: Same as current

Information By: Katholieke Universiteit Leuven

Dates:
Date Received: July 3, 2014
Date Started: February 2011
Date Completion:
Last Updated: September 19, 2014
Last Verified: September 2014