An interventional study of ETAF and Usual care in Hematologic Neoplasms, sponsored by Azienda USL Reggio Emilia - IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Not applicable, Interventional, and Treatment
Among 98 studies in Hematologic Neoplasms with a site in Italy — 28 open to participants now, 35 under way, 5 of them phase 3. Hematologic Neoplasms · Italy.
Among the 98 studies in Hematologic Neoplasms with a site in Italy, this one is the 50th largest by enrollment of the 71 interventional ones that give a count, is one of 7 that started in 2018, is one of 10 with no phase, and was the 46th registered.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
Browse Hematologic Neoplasms studies →28 of the 98 studies in Hematologic Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
CSL Behring · Sites in Italy, United States, Belgium and 8 more countries
Quetzal Therapeutics · Sites in Italy, United States, France and 2 more countries
Azienda USL Reggio Emilia - IRCCS · Sites in Italy
Daiichi Sankyo · Sites in Italy, United States, France and 1 more country
Incyte Corporation · Sites in Italy, United States, Australia and 2 more countries
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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98 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 38 · Phase 3 16
First in 2000; this study’s year is marked. 7 started in 2018.
This study's enrollment of 46 is close to the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Median enrollment 80 across the 71 interventional studies, 250 across the 26 observational. Of the 50 that completed or were terminated, 21 (42%) have results posted.
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50 of 98 have an industry lead sponsor. The 10 most frequent:
Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 93 studies on the registry; 26 are open to participants now.
Azienda USL Reggio Emilia - IRCCS has 4 studies filed under Hematologic Neoplasms — fewer than ten, so there is no comparison to draw.
8 of the studies in Hematologic Neoplasms with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07504458Phase 3Quetzal TherapeuticsPivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia | 2027-03 |
| NCT06401356Phase 3Novartis PharmaceuticalsAn Extension Study for Patients Previously Enrolled in Studies With Pelabresib | 2027-06-02 |
| NCT06001788Kura Oncology, Inc.Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia | 2026-12 |
| NCT06782373Swedish Orphan BiovitrumA Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS) | 2026-12-30 |
| NCT06645886Kumquat Biosciences Inc.A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies | 2027-03 |
Among the 98 studies in Hematologic Neoplasms with a site in Italy, from their registry updates:
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To date, studies published on multidimensional rehabilitation programs are addressed to patients with different types of cancer and, frequently, these studies only include a limited number of patients with blood neoplasms. So, there is no evidence of the effectiveness of multidimensional rehabilitation programs in this particular category of patients. A systematic review of the effectiveness of aerobic exercise alone, not associated with therapeutic education, has recently been conducted in adult individuals with hematological malignancies (reference 25386666). The review highlighted the effectiveness of physical activity on the quality of life of the target population. However, the medium and long term effects that physical exercise have on other clinically relevant endpoints, such as fatigue, psychological distress, and physical performance level, remain to be clarified. Thus, it is important to investigate the effectiveness of multidimensional interventions that integrate physical activity to therapeutic education targeted at the specific needs of individuals with blood neoplasm.
The aim of this study is to evaluate, in blood cancer patients, the feasibility of a therapeutic education program associated with physical activity, and to verify its effect by a long-term follow-up.
This is a randomized controlled pilot study • Control Group will be offered usual care (UC), which includes two sessions of therapeutic education delivered in small groups. In these educational sessions, patients are provided with useful information on communication strategies, problem solving strategies, recognition and management of symptoms and the management of any aids/orthoses provided in everyday life, etc. In the meetings, it will be emphasized the importance of maintaining an active lifestyle as much as possible by encouraging involvement in physical activity even during the cancer treatment period.
Written information material that summarizes the concepts addressed during group meetings will be provided.
In these sessions, the topics already discussed in group will be deepened, personalizing them according to the patient's characteristics. Furthermore, personalized physical activity is planned, taking into account the context of execution, the clinical condition and the patient's preferences. Patients will be trained to build an action plan aimed at self-plan physical activities and a diary will be provided to monitor the physical activity carried out autonomously.
Written information material that summarizes the concepts addressed during group and individual sessions will be provided.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control Group will be offered usual care (UC), plus two sessions of therapeutic education delivered in small groups. In these educational sessions, patients are provided with useful information on communication strategies, problem solving strategies, recognition and management of symptoms and the management of any aids/orthoses provided in everyday life, etc. In the meetings, it will be emphasized the importance of maintaining an active lifestyle as much as possible by encouraging involvement in physical activity even during the cancer treatment period. Written information material that summarizes the concepts addressed during group meetings will be provided.
Behavioral: Usual care
Intervention group will perform UC, and the two sessions of therapeutic education delivered in small group, as for the Control Group. The Intervention group will also provided for 6 individual sessions of therapeutic education and physical activity held by physiotherapists dedicated to the study, according to the patients' needs and objectives. In these sessions, the topics discussed in group will be deepened, personalizing them according to the patient's characteristics. Furthermore, personalized physical activity is planned, taking into account the context of execution, the clinical condition and the patient's preferences. The patient will be trained to build an action plan aimed at self-plan physical activities and a diary will be provided to monitor the physical activity carried out autonomously. Written information material that summarizes the concepts addressed during group and individual sessions will be provided.
Behavioral: ETAF
Therapeutic education and Physical activity
Usual care
Rate of adherence to ETAF
rate of adherence to experimental intervention: ratio between planned intervention and actual intervention (process indicator).
Time frame: 18 months (on average) - through study completion
Effect size on Fatigue
The size of the effect of ETAF, compared to the usual care, will be estimated on cancer-related fatigue (FACIT Fatigue Scale);
Time frame: 6 months
Effect size on QoL
The size of the effect of ETAF, compared to the usual care, will also be estimated on quality of life (EORTC Quality of life Questionnaire-C30);
Time frame: 6 months
Effect size Psychological distress
The size of the effect of ETAF, compared to the usual care, will also be estimated on psychological distress (NCCN Distress Thermometer and Problem list for patients);
Time frame: 6 months
Effect size on Physical function
The size of the effect of ETAF, compared to the usual care, will also be estimated on Physical function (Time up and go and 6MWT)
Time frame: 6 months
Effect of patient education - adherence
The effect of the educational intervention will be assessed through: - degree of patient's adherence to an active lifestyle (Kirkpatrick's taxonomy level 4) (Kirkpatrick, 1996).
Time frame: 6 months
Effect of patient education - satisfaction
The effect of the educational intervention will be assessed through: - degree of satisfaction of the patient involved in the study and perception of the utility of the treatment provided (Kirkpatrick's taxonomy level 1) (Kirkpatrick, 1996).
Time frame: 6 months
Plan to share: No
Ran from Jan 2018 to primary completion in Aug 2019, 19 months.
Of 185 non-industry interventional studies with no phase under Hematologic Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 125. This study's 19 months is below that.
Counting every sponsor, half of 191 studies reached it within 40 months; a quarter within 21 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Azienda USL Reggio Emilia - IRCCS