Tw HER2 Positive Breast Cancer Productivity & Utility Study
Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine.
Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment.
The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine.
Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment.
The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 100
- Recrutement
- National Taiwan University Hospital
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Contact:
- Ching-Hung Lin, Ph.D
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Aged 18 years or over;
- Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). [HER2-positive is defined as IHC3+ and/or ISH≥2.0]
- eBC patients should have received at least 2 cycles of adjuvant anti-cancer therapy following surgery at time of interview; metastasis breast cancer (mBC) patients should have received at least 1 cycle of treatment for their metastatic disease at time of interview.
- Able to provide written, informed consent.
Exclusion Criteria:
- Patients with ECOG performance status (PS) ≥3
- Unwilling or unable to provide written, informed consent
- Unable to complete written quality of life questionnaires
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Group1
Patients currently undergoing treatment for early breast cancer (either targeted HER2 therapy and chemotherapy OR targeted HER therapy alone)
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Group2
Patients with early breast cancer who have completed treatment and are in disease-free survival (i.e.
no longer receiving locoregional treatment, chemotherapy or targeted HER2 therapy; patients may still be receiving hormone therapy)
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Group3
Patients receiving treatment for metastatic breast cancer
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Work Productivity and Activity Impairment
Délai: 1 year
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• Percent work time missed due to health: Hours missed due to health problems/(Hours missed due to health problems+ Hours actually worked) • Percent impairment while working due to health: Degree health affected productivity while working/10 • Percent overall work impairment due to health: Hours missed due to health problems/(Hours missed due to health problems+ Hours actually worked)+[(1-( hours missed due to health problems/( hours missed due to health problems+ hours actually worked)))x(degree health affected productivity while working/10)] • Percent activity impairment due to health: Degree health affected regular activities/10 |
1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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EQ-5D-5L
Délai: 1 year
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The descriptive system of EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
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1 year
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EQ Visual Analogue scale (EQ VAS)
Délai: 1 year
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The EQ VAS records the respondent's self-rated health on a visual analogue scale.
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1 year
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Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
Délai: 1 year
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the FACT-B consists of the following subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB), social/family well-being (SWB), and breast cancer-specific concerns (BCS).
A total FACT-B score is calculated by summing the subscales.
The instrument has a total of 41 items asking respondents to rate how true each statement is for the last 7 days.
Response scales range from 0 (not at all) to 4 (very much).
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1 year
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Demographics
Délai: 1 year
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age, gender, height, weight, marital status, education level, employment status, monthly household income, and family history of breast cancer
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1 year
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Site of survey administration
Délai: 1 year
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north, central and south
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1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Ching-Hung Lin, Ph.D, National Taiwan University Hospital
- Chaise d'étude: Liang-Chih Liu, Ph.D, China Medical University Hospital
- Chaise d'étude: Ming-Feng Hou, M.D., Kaohsiung Medical University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ML40952
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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