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Investigating Patient Satisfaction With Oral Anti-cancer Treatment in Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer (IPSOC-mamma)

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ClinicalTrials.gov Identifier: NCT02875951
Recruitment Status : Unknown
Verified August 2016 by Sandra De Coster, KU Leuven.
Recruitment status was:  Recruiting
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Sandra De Coster, KU Leuven

Brief Summary:

A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and exemestane.

The main objective of the study is to evaluate medication adherence in postmenopausal, hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy, with focus on the patient perspective, will be investigated:

  • Patient satisfaction with treatment information
  • Patient satisfaction with treatment
  • Health-related quality of life
  • Treatment efficacy
  • Treatment-related toxicity
  • Patient follow-up by the oncologic team/general practitioner and or specialized home nurses

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
ER Positive, HER2 Negative Breast Cancer Neoplasms

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-interventional, Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care and the Treatment of Postmenopausal Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer Treated With Everolimus and Exemestane.
Study Start Date : September 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
ER positive, HER2 negative breast cancer patients
Postmenopausal patients with hormone receptor positive, HER2 receptor negative breast cancer



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 two separate pill boxes which electronically record openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in these chips 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. Patient Satisfaction with Cancer Treatment Education (Ps-CaTE) [ Time Frame: one year ]
    Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire at the start of the treatment and after approximately 1, 3, 6 and 12 months of treatment

  2. Morisky Medication Adherence Scale (MMAS) [ Time Frame: one year ]
    Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment.

  3. Cancer Therapy Satisfaction Questionnaire (CTSQ) [ Time Frame: one year ]
    Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment.

  4. Functional Assessment of Cancer Therapy - for patients with breast cancer (FACT-B) [ Time Frame: one year ]
    Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment and after approximately 1, 3, 6 and 12 months of treatment.

  5. Tumor status evaluation [ Time Frame: one year ]
    Tumor status evaluation of the patient will be assessed by the treating oncologist by CA15-3 & CEA markers at the start of the study and after 1, 3, 6 and 12 months of treatment.

  6. Tumor status evaluation [ Time Frame: one year ]
    Tumor status evaluation of the patient will be assessed by the treating oncologist by RECIST criteria after 1, 3, 6 and 12 months of treatment.

  7. Performance status of the patient [ Time Frame: one year ]
    Performance status of the patient will be assessed by the treating oncologist by ECOG criteria at the start of the study and after 1, 3, 6 and 12 months of treatment.

  8. Toxicity of treatment [ Time Frame: one year ]
    Severity of adverse events and relation to the treatment will be assessed by the treating oncologist, based on CTC-NCI 4.0, after 1, 3, 6 and 12 months of treatment.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausal women with hormone-receptor positive, HER2 receptor negative advanced breast cancer, without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor, starting with a combination treatment of everolimus & exemestane
Criteria

Inclusion Criteria:

  • Postmenopausal women, 18 years or older
  • Signed written informed consent
  • Patient can be contacted by phone and/or e-mail
  • HR+, HER2- advanced or metastatic breast cancer
  • Recurrence or progression following a non-steroidal aromatase inhibitor
  • Able to swallow and retain oral medication
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2

Exclusion Criteria:

  • Patients who are not able to understand Dutch or French
  • Symptomatic visceral metastatic disease
  • Patients who have taken an investigational drug within 28 days or 5 half-lives, whichever is shorter, prior to recruitment
  • Current use of a prohibited medication as described in the SPC
  • Any serious or unstable pre-existing medical conditions, psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedure
  • Hypersensitivity to the active substances or to any of the excipients

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): NCT02875951


Contacts
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Contact: Sandra De Coster, pharmacist +3216377180 sandra.decoster@pharm.kuleuven.be
Contact: Veerle Foulon, professor +3216323464 veerle.foulon@pharm.kuleuven.be

Locations
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Belgium
Katholieke Universiteit Leuven - Clinical Pharmacology and Pharmacotherapeutics Recruiting
Leuven, Brabant, Belgium, 3000
Contact: Sandra De Coster, pharmacist    +3216377180    sandra.decoster@pharm.kuleuven.be   
Contact: Veerle Foulon, professor    +3216323464    veerle.foulon@pharm.kuleuven.be   
Sub-Investigator: Sandra De Coster         
Principal Investigator: Veerle Foulon         
Sponsors and Collaborators
KU Leuven
Novartis
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Responsible Party: Sandra De Coster, Pharmacist, KU Leuven
ClinicalTrials.gov Identifier: NCT02875951    
Other Study ID Numbers: VF/2014/03
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases