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NCT Number: NCT02247583

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.

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Flemish League Against Cancer
  • GlaxoSmithKline
  • Novartis
  • Pfizer

Registry information

Official study 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.

Acronym: IPSOC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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