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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01444456
First received: September 29, 2011
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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


Condition
Anemia
Breast Cancer
Cancer
Colorectal Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Solid Tumors
Bladder Cancer
Endometrial Cancer
Renal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points [ Time Frame: Baseline and Week 9 ] [ Designated as safety issue: No ]
    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).

  • Time to First Increase in Hemoglobin [ Time Frame: From Baseline until Week 9 ] [ Designated as safety issue: No ]
    Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL

  • Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time [ Time Frame: From Baseline to Week 13 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time [ Time Frame: From Baseline to Week 13 ] [ Designated as safety issue: No ]
    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).


Enrollment: 1262
Study Start Date: October 2011
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444456

  Show 118 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01444456     History of Changes
Other Study ID Numbers: 20101123
Study First Received: September 29, 2011
Results First Received: July 24, 2014
Last Updated: July 24, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
Austria: Central Ethics Committee
Belgium: Ethisch committee Imelda ziekenhuis Bonheiden
Germany: Central associations of the statutory health insurance funds
Germany: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Panel Doctors' Association
Italy: Comitato Etico della Fondazione Istituto San Raffaele-G.Giglio di Cefalù
Netherlands: 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 santé
France: French Data Protection Authority
Romania: Ministry of Public Health

Keywords provided by Amgen:
Breast Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Colorectal Cancer
Aranesp
Chemotherapy induced anaemia
Chemotherapy
Bladder Cancer
Endometrial Cancer
Renal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer

Additional relevant MeSH terms:
Anemia
Breast Neoplasms
Carcinoma, Renal Cell
Colorectal Neoplasms
Esophageal Neoplasms
Kidney Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Stomach Neoplasms
Urinary Bladder Neoplasms
Adenocarcinoma
Adnexal Diseases
Breast Diseases
Carcinoma
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014