Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Breast Cancer Clinical Trial

Official title:

Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444456
• Other study ID #: 20101123
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: July 24, 2014
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im GesundheitswesenAustria: Central Ethics CommitteeBelgium: Ethisch committee Imelda ziekenhuis BonheidenGermany: Central associations of the statutory health insurance fundsGermany: Ethics CommitteeGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Panel Doctors' AssociationItaly: Comitato Etico della Fondazione Istituto San Raffaele-G.Giglio di CefalùNetherlands: METOPP (Medisch-Ethische Toetsing Onderzoek Patiënten en Proefpersonen)France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: French Data Protection AuthorityRomania: Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

Description:

Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by patients receiving a specific agent in a drug class.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1262
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer

• Expected to receive at least 8 additional weeks of a given regimen of myelosuppressive chemotherapy after enrolment

• Starting treatment with either darbepoetin alfa (in Cohort 1 countries) or any ESA (in Cohort 2 countries) as per European Summary of Product Characteristics (SPC) for symptomatic anaemia.

Exclusion Criteria:

• Received any ESA treatment or Red Blood Cell (RBC) transfusion within 28 days prior to enrolment

• Known primary benign or malignant haematologic disorder which can cause anaemia

• Known hypersensitivity to ESAs

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Bladder Cancer
• Breast Cancer
• Cancer
• Carcinoma, Renal Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Endometrial Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Kidney Neoplasms
• Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Renal Cancer
• Solid Tumors
• Stomach Neoplasms
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	St Poelten
Austria	Research Site	Vöcklabruck
Austria	Research Site	Wels
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brasschaat
Belgium	Research Site	Brugge
Belgium	Research Site	Eupen
Belgium	Research Site	Gilly
Belgium	Research Site	Mechelen
Belgium	Research Site	Namur
Belgium	Research Site	Oostende
Belgium	Research Site	Sint-Niklaas
Belgium	Research Site	Verviers
France	Research Site	Aix en Provence
France	Research Site	Aix en Provence
France	Research Site	Aix en Provence cedex 01
France	Research Site	Amiens
France	Research Site	Aubagne
France	Research Site	Bayonne
France	Research Site	Besançon Cedex
France	Research Site	Bordeaux
France	Research Site	Boulogne sur Mer Cédex
France	Research Site	Bourg en Bresse
France	Research Site	Brive la Gaillarde
France	Research Site	Carcassonne
France	Research Site	Clermont Ferrand
France	Research Site	Clermont Ferrand
France	Research Site	Colmar Cedex
France	Research Site	Dijon
France	Research Site	Draguignan Cedex
France	Research Site	La Seyne Sur Mer
France	Research Site	Le Mans Cedex 9
France	Research Site	Longjumeau cedex 1
France	Research Site	Marseille
France	Research Site	Marseille Cedex 03
France	Research Site	Mont de Marsan
France	Research Site	Montauban cedex
France	Research Site	Nancy
France	Research Site	Orléans
France	Research Site	Paris Cedex 20
France	Research Site	Périgueux cedex
France	Research Site	Pontoise Cedex
France	Research Site	Pringy Cedex
France	Research Site	Reims
France	Research Site	Reims
France	Research Site	Reims Cedex
France	Research Site	Rennes
France	Research Site	Rouen
France	Research Site	Saint Grégoire cedex
France	Research Site	Saint Quentin
France	Research Site	Soissons Cedex
France	Research Site	Soyaux
France	Research Site	Strasbourg
France	Research Site	Vichy cedex
France	Research Site	Villefranche Sur Saone Cedex
France	Research Site	Villejuif Cedex
Germany	Research Site	Augsburg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bremerhaven
Germany	Research Site	Gelsenkirchen
Germany	Research Site	Goslar
Germany	Research Site	Halle (Saale)
Germany	Research Site	Köln
Germany	Research Site	Mannheim
Germany	Research Site	Neunkirchen
Germany	Research Site	Rotenburg (Wümme)
Germany	Research Site	Soest
Germany	Research Site	Stralsund
Germany	Research Site	Würselen
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Chania
Greece	Research Site	Marousi
Greece	Research Site	Papagou
Italy	Research Site	Cefalù PA
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Roma
Italy	Research Site	Torino
Netherlands	Research Site	Amstelveen
Netherlands	Research Site	Dordrecht
Netherlands	Research Site	Enschede
Netherlands	Research Site	Leiderdorp
Netherlands	Research Site	Purmerend
Netherlands	Research Site	Roosendaal
Netherlands	Research Site	Vlissingen
Netherlands	Research Site	Zutphen
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Konin
Poland	Research Site	Koszalin
Poland	Research Site	Krakow
Poland	Research Site	Lubin
Poland	Research Site	Olsztyn
Poland	Research Site	Poznan
Poland	Research Site	Walbrzych
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Romania	Research Site	Alba Iulia
Romania	Research Site	Baia Mare
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Oradea
Romania	Research Site	Ramnicu Valcea
Romania	Research Site	Targu Mures
Romania	Research Site	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin = 1 g/dL	Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of = 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as = 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).	Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.	No
Secondary	Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin = 1 g/dL	Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of = 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as = 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).	Baseline to Week 9	No
Secondary	Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points	The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).	Baseline and Week 9	No
Secondary	Time to First Increase in Hemoglobin	Time from Baseline to first increase in hemoglobin of = 1 g/dL	From Baseline until Week 9	No
Secondary	Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time	The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of = 3.5 points from Baseline (the minimally important difference [MID]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).	From Baseline to Week 13	No
Secondary	Percentage of Participants With Increase in Hemoglobin = 1 g/dL at Any Time	The percentage of participants with increase in hemoglobin (= 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).	From Baseline to Week 13	No

External Links

•   AmgenTrials clinical trials website