Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 5:23 AM
Study NCT ID:
NCT02875951
Status:
UNKNOWN
Last Update Posted:
2016-08-23
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Patient Satisfaction With Oral Anti-cancer Treatment in Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer
Sponsor:
KU Leuven
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPSOC-mamma
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: