AdultPROMYSNCT00809575
Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes
An observational study of Adult and Myelodysplastic Syndromes, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 53 sites in 12 countries.
Trial summary
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult, Myelodysplastic Syndromes
- What is being tested?
- questionnaire administration, fatigue assessment and management and observation
- How many people
- 927 participants
- Where
- 53 sitesin 12 countries
- Study dates
- 2 Oct 2008to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with myelodysplastic syndromes (MDS).
Who may be able to join
- Patients with newly diagnosed myelodysplastic syndrome (MDS) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 3 months before date of registration.
- Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-Fatigue and Control Preference Scale).
- Adult patients (≥ 18 years old).
- Written informed consent provided.
Who cannot join
- Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins;
- Patients with therapy related MDS.
- Having any kind of psychiatric disorder or major cognitive dysfunction.
- Not able to read and understand local language.
Trial locations and contacts
53 sites in 12 countries.
53 sites in 12 countries
Italy33 sites
Asl Di Asti - Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
Asti
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, 70010
ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo
Cagliari
CTMO - Ematologia - Ospedale "Binaghi"
Cagliari
Ospedale "Ferrarotto"
Catania
A.O. Pugliese Ciaccio
Catanzaro
Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona
Aou Careggi - Firenze - Sod Ematologia
Florence
Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""
Genova, 16132
U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea
Ivrea, Torino, 10015
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
Lecce, 73100
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
Meldola
U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
Milan, 20132
Ospedale Niguarda "Ca Granda"
Milan, 20162
UO Ematologia - AOU Policlinico di Modena
Modena
Asst Di Monza - Ospedale S. Eugenio - Uo Ematologia E Cta
Monza
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, 28100
Ospedale S. Luigi Gonzaga
Orbassano
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
Pavia, 27100
Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia
Reggio Emilia
Divisione Ematologia - Università Campus Bio-Medico
Roma, 00128
Università degli Studi - Policlinico di Tor Vergata
Roma, 00133
Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, 00161
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, 00168
Complesso Ospedaliero S. Giovanni Addolorata
Roma, 00184
U.O.C. Ematologia - Ospedale S.Eugenio
Rome
SOS Dipartimento di Oncoematologia Osp. Rovigo
Rovigo, 45100
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
Sassari
Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette
Torino
Belgium4 sites
ZNA Middelheim
Antwerp
AZ Sint-Jan AV, Department of Hematology
Bruges
CH Jolimont
Brussels
CHC - Centre Hospitalier Chrétien
Liège
United Kingdom3 sites
Bradford Institute of Health Research
Bradford
St James's University Hospital
Leeds
London North West Healthcare NHS Trust
London
United States2 sites
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center (MSKCC)
New York, New York, 10065
China2 sites
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
China
Kunming Medical University
Kunming
France2 sites
Saint - Cloud Medecin des CLCC Hematologie Service E Hopital ReneHuguenin - Institut Curie
Saint-Cloud
Purpan Hospital - Internal Medicine Department
Toulouse
Germany2 sites
Department of Hematology - Universitatsklinikum Carl Gustav Carus
Dresden
University of Freiburg Medical Center
Freiburg im Breisgau
Brazil1 site
Curitiba Unidade de Hematologia - Hemoterapia e Oncologia. Setor de Transplante de Medula Ossea. Complexo Hospital de Clinicas da Universidade Federal do Parana (CHC-UFPR)
Curitiba
Croatia1 site
Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka
Rijeka
About this study
Official title: Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.
PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.
Read the detailed description
This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This project has thus a number of goals. The main objective of the protocol is to improve our understanding of the possible added prognostic value of patients' judgment on their own health status and its potential clinical implications. This would aim at providing clinicians with an easy and brief to administer patient-reported health status scale or tool to be used to make more informed treatment decisions. In addition, along with other recent evidence (also looking at the prognostic value of patients' health status judgment in MDS patients), the data of this research could possibly serve to devise a patient-based prognostic index to be used in this higher risk population.
- Conditions
- Adult, Myelodysplastic Syndromes
- Being tested
- questionnaire administration, fatigue assessment and management, observation, quality-of-life assessment
- Keywords
- adult, de novo myelodysplastic syndromes, Quality of life, Patient reported outcomes
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
fatigue assessment and managementOther
observationOther
quality-of-life assessmentOther
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients.
Measured: After 5 years from study entry.
Secondary outcomes (9)
To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes.
i.e. overall survival, AML transformation, toxicity and response to therapy.
Measured: After 5 years from study entry.
To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy.
Measured: After 5 years from study entry.
To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories.
Measured: After 5 years from study entry.
To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.
Measured: After 5 years from study entry.
To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.
Measured: After 5 years from study entry.
To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes.
Measured: After 5 years from study entry.
To devise a prognostic patient-based index.
Measured: After 5 years from study entry.
To evaluate accuracy of clinical prediction of survival.
Measured: After 5 years from study entry.
To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics.
Measured: After 5 years from study entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study start2 Oct 2008
- Primary completion8 Oct 2018
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Efficace, PhD, Principal investigator, Gruppo Italiano Malattie EMatologiche dell'Adulto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809575
- Sponsor's protocol ID
- QOL-MDS0108
- Other IDs
- GIMEMA-QOL-MDS-0108, EU-20885
- Acronym
- PROMYS
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2008
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Efficace F, Gaidano G, Sprangers M, Cottone F, Breccia M, Voso MT, Caocci G, Stauder R, Di Tucci AA, Sanpaolo G, Selleslag D, Angelucci E, Platzbecker U, Mandelli F. Preference for involvement in treatment decisions and request for prognostic information in newly diagnosed patients with higher-risk myelodysplastic syndromes. Ann Oncol. 2014 Feb;25(2):447-54. doi: 10.1093/annonc/mdt557.
PubMed 24478321Caocci G, Voso MT, Angelucci E, Stauder R, Cottone F, Abel G, Nguyen K, Platzbecker U, Beyne-Rauzy O, Gaidano G, Invernizzi R, Molica S, Criscuolo M, Breccia M, Lubbert M, Sanpaolo G, Buccisano F, Ricco A, Palumbo GA, Niscola P, Zhang H, Fenu S, La Nasa G, Mandelli F, Efficace F. Accuracy of physician assessment of treatment preferences and health status in elderly patients with higher-risk myelodysplastic syndromes. Leuk Res. 2015 Aug;39(8):859-65. doi: 10.1016/j.leukres.2015.05.012. Epub 2015 Jun 12.
PubMed 26120100Efficace F, Gaidano G, Breccia M, Criscuolo M, Cottone F, Caocci G, Bowen D, Lubbert M, Angelucci E, Stauder R, Selleslag D, Platzbecker U, Sanpaolo G, Jonasova A, Buccisano F, Specchia G, Palumbo GA, Niscola P, Wan C, Zhang H, Fenu S, Klimek V, Beyne-Rauzy O, Nguyen K, Mandelli F. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes. Br J Haematol. 2015 Feb;168(3):361-70. doi: 10.1111/bjh.13138. Epub 2014 Oct 1.
PubMed 25272332Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, Caocci G, Stauder R, Selleslag D, Sprangers M, Platzbecker U, Ricco A, Sanpaolo G, Beyne-Rauzy O, Buccisano F, Palumbo GA, Bowen D, Nguyen K, Niscola P, Vignetti M, Mandelli F. Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study. Lancet Oncol. 2015 Nov;16(15):1506-1514. doi: 10.1016/S1470-2045(15)00206-5. Epub 2015 Sep 21.
PubMed 26404501Efficace F, Cottone F, Abel G, Niscola P, Gaidano G, Bonnetain F, Anota A, Caocci G, Cronin A, Fianchi L, Breccia M, Stauder R, Platzbecker U, Palumbo GA, Luppi M, Invernizzi R, Bergamaschi M, Borin L, Di Tucci AA, Zhang H, Sprangers M, Vignetti M, Mandelli F. Patient-reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes. Cancer. 2018 Mar 15;124(6):1251-1259. doi: 10.1002/cncr.31193. Epub 2017 Dec 12.
PubMed 29231969Efficace F, Cottone F, Oswald LB, Cella D, Patriarca A, Niscola P, Breccia M, Platzbecker U, Palumbo GA, Caocci G, Stauder R, Ricco A, Petranovic D, Caers J, Luppi M, Fianchi L, Frairia C, Capodanno I, Follini E, Sarlo C, Fazi P, Vignetti M. The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index. Leukemia. 2020 Sep;34(9):2451-2459. doi: 10.1038/s41375-020-0746-8. Epub 2020 Feb 21.
PubMed 32086447
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study
- ClinicalTrials.gov ID
- NCT00809575
- Acronym / sponsor ID
- PROMYS / QOL-MDS0108
- Conditions
- Adult, Myelodysplastic Syndromes
- Keywords
- adult, de novo myelodysplastic syndromes, Quality of life, Patient reported outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 927 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 2 Oct 2008 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- Feb 2021 (estimated)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.
PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.
Detailed description
This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This project has thus a number of goals. The main objective of the protocol is to improve our understanding of the possible added prognostic value of patients' judgment on their own health status and its potential clinical implications. This would aim at providing clinicians with an easy and brief to administer patient-reported health status scale or tool to be used to make more informed treatment decisions. In addition, along with other recent evidence (also looking at the prognostic value of patients' health status judgment in MDS patients), the data of this research could possibly serve to devise a patient-based prognostic index to be used in this higher risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with myelodysplastic syndromes (MDS).
Key inclusion criteria (4 listed)
- Patients with newly diagnosed myelodysplastic syndrome (MDS) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 3 months before date of registration.
- Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-Fatigue and Control Preference Scale).
- Adult patients (≥ 18 years old).
- Written informed consent provided.
Key exclusion criteria (4 listed)
- Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins;
- Patients with therapy related MDS.
- Having any kind of psychiatric disorder or major cognitive dysfunction.
- Not able to read and understand local language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | – |
| fatigue assessment and management | Other | – |
| observation | Other | – |
| quality-of-life assessment | Other | – |
Primary outcome
To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients.
Time frame: After 5 years from study entry.
9 secondary outcomes
To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes.
Time frame: After 5 years from study entry.
To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy.
Time frame: After 5 years from study entry.
To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories.
Time frame: After 5 years from study entry.
To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.
Time frame: After 5 years from study entry.
To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.
Time frame: After 5 years from study entry.
To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes.
Time frame: After 5 years from study entry.
To devise a prognostic patient-based index.
Time frame: After 5 years from study entry.
To evaluate accuracy of clinical prediction of survival.
Time frame: After 5 years from study entry.
To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics.
Time frame: After 5 years from study entry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 24478321Efficace F, Gaidano G, Sprangers M, Cottone F, Breccia M, Voso MT, Caocci G, Stauder R, Di Tucci AA, Sanpaolo G, Selleslag D, Angelucci E, Platzbecker U, Mandelli F. Preference for involvement in treatment decisions and request for prognostic information in newly diagnosed patients with higher-risk myelodysplastic syndromes. Ann Oncol. 2014 Feb;25(2):447-54. doi: 10.1093/annonc/mdt557.
- Background: PubMed 26120100Caocci G, Voso MT, Angelucci E, Stauder R, Cottone F, Abel G, Nguyen K, Platzbecker U, Beyne-Rauzy O, Gaidano G, Invernizzi R, Molica S, Criscuolo M, Breccia M, Lubbert M, Sanpaolo G, Buccisano F, Ricco A, Palumbo GA, Niscola P, Zhang H, Fenu S, La Nasa G, Mandelli F, Efficace F. Accuracy of physician assessment of treatment preferences and health status in elderly patients with higher-risk myelodysplastic syndromes. Leuk Res. 2015 Aug;39(8):859-65. doi: 10.1016/j.leukres.2015.05.012. Epub 2015 Jun 12.
- Background: PubMed 25272332Efficace F, Gaidano G, Breccia M, Criscuolo M, Cottone F, Caocci G, Bowen D, Lubbert M, Angelucci E, Stauder R, Selleslag D, Platzbecker U, Sanpaolo G, Jonasova A, Buccisano F, Specchia G, Palumbo GA, Niscola P, Wan C, Zhang H, Fenu S, Klimek V, Beyne-Rauzy O, Nguyen K, Mandelli F. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes. Br J Haematol. 2015 Feb;168(3):361-70. doi: 10.1111/bjh.13138. Epub 2014 Oct 1.
- Background: PubMed 26404501Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, Caocci G, Stauder R, Selleslag D, Sprangers M, Platzbecker U, Ricco A, Sanpaolo G, Beyne-Rauzy O, Buccisano F, Palumbo GA, Bowen D, Nguyen K, Niscola P, Vignetti M, Mandelli F. Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study. Lancet Oncol. 2015 Nov;16(15):1506-1514. doi: 10.1016/S1470-2045(15)00206-5. Epub 2015 Sep 21.
- Background: PubMed 29231969Efficace F, Cottone F, Abel G, Niscola P, Gaidano G, Bonnetain F, Anota A, Caocci G, Cronin A, Fianchi L, Breccia M, Stauder R, Platzbecker U, Palumbo GA, Luppi M, Invernizzi R, Bergamaschi M, Borin L, Di Tucci AA, Zhang H, Sprangers M, Vignetti M, Mandelli F. Patient-reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes. Cancer. 2018 Mar 15;124(6):1251-1259. doi: 10.1002/cncr.31193. Epub 2017 Dec 12.
- Background: PubMed 32086447Efficace F, Cottone F, Oswald LB, Cella D, Patriarca A, Niscola P, Breccia M, Platzbecker U, Palumbo GA, Caocci G, Stauder R, Ricco A, Petranovic D, Caers J, Luppi M, Fianchi L, Frairia C, Capodanno I, Follini E, Sarlo C, Fazi P, Vignetti M. The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index. Leukemia. 2020 Sep;34(9):2451-2459. doi: 10.1038/s41375-020-0746-8. Epub 2020 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Efficace, PhD principal investigator
Gruppo Italiano Malattie EMatologiche dell'Adulto
53 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult and Myelodysplastic Syndromes, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 53 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Italy, Belgium, United Kingdom, United States, China and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients. (time frame: After 5 years from study entry.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809575, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.