Hematologic MalignanciesNCT04581187
An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies
An observational study of Hematologic Malignancies, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 27 sites in Italy.
Trial summary
This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Quality of life assessment
- How many people
- 400 participants
- Where
- 27 sitesItaly
- Study dates
- 2 Dec 2020to Dec 2024
- How long will I take part?
- 2 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients diagnosed with any hematologic malignancy
Who may be able to join
- Diagnosis of any hematologic malignancy according to 2016 WHO classification
- Adult Patients (≥18 years).
- Written informed consent
Who cannot join
- Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
- Not able to read and understand local language
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites, 27 recruiting
- Not yet recruiting
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona
Ancona
- Not yet recruiting
Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
Aviano
- Not yet recruiting
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
- Recruiting
Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia
Bari
- Not yet recruiting
Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia
Barletta
Giuseppe Tarantini
- Recruiting
AO Brotzu, Presidio Ospedaliero A. Businco - Cagliari - SC Ematologia E CTMO
Cagliari
- Not yet recruiting
Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia
Catania
- Recruiting
Aou Ospedali Riuniti - Foggia- UOC Ematologia
Foggia
- Recruiting
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce
- Recruiting
Aou Di Modena- Sc Ematologia- Dipartimento Di Oncologia Ed Ematologia
Modena
- Recruiting
Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia
Naples
- Recruiting
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara
Novara
- Recruiting
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo
- Recruiting
Aou Policlinico P. Giaccone - Uo Ematologia Dipartimento Biomedico Di Medicina Interna E Specialistica
Palermo
- Not yet recruiting
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara
- Recruiting
Ausl Reggio Emilia, Presidio Ospedaliero "Arcispedale Santa Maria Nuova" - Irccs- Uo Ematologia
Reggio Emilia
- Recruiting
Ao San Camillo Forlanini - Uoc Ematologia E Trapianto Cellule Staminali
Roma
- Not yet recruiting
AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali
Roma
- Recruiting
Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
Roma
- Recruiting
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma
- Recruiting
Divisione di Ematologia - Ospedale S. Eugenio
Roma
- Recruiting
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma
- Recruiting
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo
- Recruiting
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari
- Not yet recruiting
Ospedale Di Sassuolo Spa - Ematologia
Sassuolo
- Recruiting
Asl To 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
Torino
- Not yet recruiting
Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino
About this study
Official title: An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs
This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.
- Conditions
- Hematologic Malignancies
- Being tested
- Quality of life assessment
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessmentOther
Quality of life questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQOL in adult patients with hematologic malignancies
To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Measured: After 2 years from date of registration
Symptoms in adult patients with hematologic malignancies
To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Measured: After 2 years from date of registration
Adherence to therapy in adult patients with hematologic malignancies
To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Measured: After 2 years from date of registration
Secondary outcomes (5)
Prevalence of clinically relevant functional limitations and symptoms
To describe the prevalence of clinically relevant functional limitations (e.g., physical and social) and symptoms (e.g., fatigue, pain and dyspnea) by type of hematologic malignancy and by type of treatment (e.g., standard chemotherapy of oral anticancer therapies)
Measured: After 2 years from date of registration
Factors associated with physical and mental health concerns, as measured by EORTC QLQ-C30 questionnaire
To investigate factors associated with physical and mental health concerns
Measured: After 2 years from date of registration
Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes
To examine the financial and social impact imposed by the COVID-19 pandemic on patient health outcomes
Measured: After 2 years from date of registration
Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes
To examine the limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes
Measured: After 2 years from date of registration
Clinical strategies adopted by physicians
To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios
Measured: After 2 years from date of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start2 Dec 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies 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
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Vignetti, Principal investigator, GIMEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581187
- Sponsor's protocol ID
- GIMEMA-ALLIANCE Platform
- Status last verified
- May 2021
- First submitted
- 30 Sep 2020
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Efficace F, Breccia M, Fazi P, Cottone F, Holzner B, Vignetti M. The GIMEMA-ALLIANCE Digital Health Platform for Patients With Hematologic Malignancies in the COVID-19 Pandemic and Postpandemic Era: Protocol for a Multicenter, Prospective, Observational Study. JMIR Res Protoc. 2021 Jun 1;10(6):e25271. doi: 10.2196/25271.
PubMed 33890580
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs
- ClinicalTrials.gov ID
- NCT04581187
- Acronym / sponsor ID
- GIMEMA-ALLIANCE Platform
- Conditions
- Hematologic Malignancies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Oct 2020 (actual)
- 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.
This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with any hematologic malignancy
Key inclusion criteria (3 listed)
- Diagnosis of any hematologic malignancy according to 2016 WHO classification
- Adult Patients (≥18 years).
- Written informed consent
Key exclusion criteria (2 listed)
- Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
- 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 |
|---|---|---|
| Quality of life assessmentQuality of life questionnaires | Other | – |
Primary outcome
HRQOL in adult patients with hematologic malignancies
Time frame: After 2 years from date of registration
To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Symptoms in adult patients with hematologic malignancies
Time frame: After 2 years from date of registration
To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Adherence to therapy in adult patients with hematologic malignancies
Time frame: After 2 years from date of registration
To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
5 secondary outcomes
Prevalence of clinically relevant functional limitations and symptoms
Time frame: After 2 years from date of registration
Factors associated with physical and mental health concerns, as measured by EORTC QLQ-C30 questionnaire
Time frame: After 2 years from date of registration
Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes
Time frame: After 2 years from date of registration
Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes
Time frame: After 2 years from date of registration
Clinical strategies adopted by physicians
Time frame: After 2 years from date of registration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 33890580Efficace F, Breccia M, Fazi P, Cottone F, Holzner B, Vignetti M. The GIMEMA-ALLIANCE Digital Health Platform for Patients With Hematologic Malignancies in the COVID-19 Pandemic and Postpandemic Era: Protocol for a Multicenter, Prospective, Observational Study. JMIR Res Protoc. 2021 Jun 1;10(6):e25271. doi: 10.2196/25271.
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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.
Marco Vignetti principal investigator
GIMEMA Foundation
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancies, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 27 sites in Italy.
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 3 inclusion and 2 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 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy. 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?
Contact Fabio Efficace (+39 06441639831, alliance@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQOL in adult patients with hematologic malignancies (time frame: After 2 years from date of registration). The study lists 3 primary outcomes in all. 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 NCT04581187, which also lists 1 linked publication.
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 17 May 2021.