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

February 7, 2017 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1262

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

  • Austria
      • Graz, Austria, 8042
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • St Poelten, Austria, 3100
        • Research Site
      • Vöcklabruck, Austria, 4840
        • Research Site
      • Wels, Austria, 4600
        • Research Site
      • Wien, Austria, 1090
        • Research Site
  • Belgium
      • Aalst, Belgium, 9300
        • Research Site
      • Bonheiden, Belgium, 2820
        • Research Site
      • Brasschaat, Belgium, 2930
        • Research Site
      • Brugge, Belgium, 8000
        • Research Site
      • Eupen, Belgium, 4700
        • Research Site
      • Gilly, Belgium, 6060
        • Research Site
      • Mechelen, Belgium, 2800
        • Research Site
      • Namur, Belgium, 5000
        • Research Site
      • Oostende, Belgium, 8400
        • Research Site
      • Sint-Niklaas, Belgium, 9100
        • Research Site
      • Verviers, Belgium, 4800
        • Research Site
  • France
      • Aix en Provence, France, 13100
        • Research Site
      • Aix en Provence, France, 13616
        • Research Site
      • Aix en Provence cedex 01, France, 13616
        • Research Site
      • Amiens, France, 80000
        • Research Site
      • Aubagne, France, 13675
        • Research Site
      • Bayonne, France, 64100
        • Research Site
      • Besançon Cedex, France, 25030
        • Research Site
      • Bordeaux, France, 33077
        • Research Site
      • Boulogne sur Mer Cédex, France, 62321
        • Research Site
      • Bourg en Bresse, France, 01012
        • Research Site
      • Brive la Gaillarde, France, 19312
        • Research Site
      • Carcassonne, France, 11890
        • Research Site
      • Clermont Ferrand, France, 63000
        • Research Site
      • Clermont Ferrand, France, 63011
        • Research Site
      • Colmar Cedex, France, 68024
        • Research Site
      • Dijon, France, 21034
        • Research Site
      • Draguignan Cedex, France, 83007
        • Research Site
      • La Seyne Sur Mer, France, 83500
        • Research Site
      • Le Mans Cedex 9, France, 72037
        • Research Site
      • Longjumeau cedex 1, France, 91161
        • Research Site
      • Marseille, France, 13009
        • Research Site
      • Marseille Cedex 03, France, 13331
        • Research Site
      • Mont de Marsan, France, 40000
        • Research Site
      • Montauban cedex, France, 82013
        • Research Site
      • Nancy, France, 54100
        • Research Site
      • Orléans, France, 45000
        • Research Site
      • Paris Cedex 20, France, 75020
        • Research Site
      • Pontoise Cedex, France, 95301
        • Research Site
      • Pringy Cedex, France, 74374
        • Research Site
      • Périgueux cedex, France, 24004
        • Research Site
      • Reims, France, 51092
        • Research Site
      • Reims, France, 51100
        • Research Site
      • Reims Cedex, France, 51056
        • Research Site
      • Rennes, France, 35033
        • Research Site
      • Rouen, France, 76000
        • Research Site
      • Saint Grégoire cedex, France, 35768
        • Research Site
      • Saint Quentin, France, 02321
        • Research Site
      • Soissons Cedex, France, 02209
        • Research Site
      • Soyaux, France, 16800
        • Research Site
      • Strasbourg, France, 67000
        • Research Site
      • Vichy cedex, France, 03207
        • Research Site
      • Villefranche Sur Saone Cedex, France, 69400
        • Research Site
      • Villejuif Cedex, France, 94804
        • Research Site
  • Germany
      • Augsburg, Germany, 86150
        • Research Site
      • Berlin, Germany, 13055
        • Research Site
      • Berlin, Germany, 13347
        • Research Site
      • Berlin, Germany, 10317
        • Research Site
      • Bremerhaven, Germany, 27568
        • Research Site
      • Gelsenkirchen, Germany, 45899
        • Research Site
      • Goslar, Germany, 38642
        • Research Site
      • Halle (Saale), Germany, 06110
        • Research Site
      • Köln, Germany, 50677
        • Research Site
      • Mannheim, Germany, 68165
        • Research Site
      • Neunkirchen, Germany, 66538
        • Research Site
      • Rotenburg (Wümme), Germany, 27356
        • Research Site
      • Soest, Germany, 59494
        • Research Site
      • Stralsund, Germany, 18435
        • Research Site
      • Würselen, Germany, 52146
        • Research Site
  • Greece
      • Athens, Greece, 18547
        • Research Site
      • Athens, Greece, 11522
        • Research Site
      • Chania, Greece, 73300
        • Research Site
      • Marousi, Greece, 15121
        • Research Site
      • Papagou, Greece, 11526
        • Research Site
  • Italy
      • Cefalù PA, Italy, 90015
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Roma, Italy, 00128
        • Research Site
      • Torino, Italy, 10100
        • Research Site
  • Netherlands
      • Amstelveen, Netherlands, 1186 AM
        • Research Site
      • Dordrecht, Netherlands, 3318 AT
        • Research Site
      • Enschede, Netherlands, 7513 ER
        • Research Site
      • Leiderdorp, Netherlands, 2353 GA
        • Research Site
      • Purmerend, Netherlands, 1441 RN
        • Research Site
      • Roosendaal, Netherlands, 4708 AE
        • Research Site
      • Vlissingen, Netherlands, 4382 EE
        • Research Site
      • Zutphen, Netherlands, 7207 AE
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Research Site
      • Gdansk, Poland, 80-402
        • Research Site
      • Konin, Poland, 62-500
        • Research Site
      • Koszalin, Poland, 75-581
        • Research Site
      • Krakow, Poland, 31-531
        • Research Site
      • Lubin, Poland, 59-300
        • Research Site
      • Olsztyn, Poland, 10-228
        • Research Site
      • Poznan, Poland, 61-878
        • Research Site
      • Walbrzych, Poland, 58-309
        • Research Site
      • Warszawa, Poland, 04-125
        • Research Site
      • Wroclaw, Poland, 51-124
        • Research Site
      • Wroclaw, Poland, 50-981
        • Research Site
  • Romania
      • Alba Iulia, Romania, 510077
        • Research Site
      • Baia Mare, Romania, 430031
        • Research Site
      • Brasov, Romania, 500366
        • Research Site
      • Bucharest, Romania, 011171
        • Research Site
      • Bucharest, Romania, 022328
        • Research Site
      • Bucharest, Romania, 020947
        • Research Site
      • Bucharest, Romania, 030442
        • Research Site
      • Bucuresti, Romania, 050659
        • Research Site
      • Cluj-Napoca, Romania, 400058
        • Research Site
      • Oradea, Romania, 410469
        • Research Site
      • Ramnicu Valcea, Romania, 240156
        • Research Site
      • Targu Mures, Romania, 540142
        • Research Site
      • Timisoara, Romania, 300167
        • Research Site

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with either breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer who will receive darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) for the treatment of symptomatic chemotherapy-induced anaemia (CIA) in routine clinical practice.

Description

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 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
Cohort 1: Darbepoetin alfa
Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
Cohort 2: Any ESA
Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL
Time Frame: 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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL
Time Frame: Baseline to Week 9
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
Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points
Time Frame: Baseline and Week 9
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
Time to First Increase in Hemoglobin
Time Frame: From Baseline until Week 9
Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL
From Baseline until Week 9
Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time
Time Frame: From Baseline to Week 13
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
Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time
Time Frame: From Baseline to Week 13
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

Collaborators and Investigators

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

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101123

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.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe