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

August 18, 2016 updated by: Sandra De Coster, KU Leuven

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.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brabant
      • Leuven, Brabant, Belgium, 3000
        • Recruiting
        • Katholieke Universiteit Leuven - Clinical Pharmacology and Pharmacotherapeutics
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sandra De Coster
        • Principal Investigator:
          • Veerle Foulon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
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.
one year
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.
one year
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.
one year
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.
one year
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.
one year
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.
one year
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (ESTIMATE)

August 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VF/2014/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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