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Investigating Patient Satisfaction With Oral Anti-Cancer Treatment (IPSOC)

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ClinicalTrials.gov Identifier: NCT02247583
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborators:
Flemish League Against Cancer
Pfizer
Novartis
GlaxoSmithKline
Information provided by (Responsible Party):
Sandra De Coster, 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.


Condition or disease
Clear Cell Renal Cell Carcinoma

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : February 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013


Group/Cohort
mRCC patients
Patients with metastatic renal cell carcinoma



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mRCC patients starting with an oral anti-cancer treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247583


Locations
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Belgium
Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Flemish League Against Cancer
Pfizer
Novartis
GlaxoSmithKline
Investigators
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Study Director: Veerle Foulon, Professor Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie

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Responsible Party: Sandra De Coster, Pharmacist, KU Leuven
ClinicalTrials.gov Identifier: NCT02247583     History of Changes
Other Study ID Numbers: VF/2010/03
s52586 ( Registry Identifier: Clinical Trial Center UZ Leuven )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases