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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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This is a prospective, multicentre, phase III, randomised, controlled intervention study.
Two groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).
Each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).
- PASCA interventional group
For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary.
- Control group
For the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management.
=> For all patients, regardless of group
All patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications:
After each screening visit, all patients randomised to the intervention group will receive the PASCA intervention:
An interpretation of the results of the screening tests concerning
Explanation of results and referrals to the patient using plain language, by a phone call, ;
Early, proactive care via a dedicated network of healthcare professionals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), specific and proactive referrals will be made systematically after each detection visit according to the level of risk, estimated on the basis of decision trees (management guide) and via the dedicated PASCA network of healthcare professionals, to initiate early treatment and follow-up where necessary. |
|
| Control group | Active Comparator | For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective): all the data from each detection visit will be sent to the referring forwarded to the referring onco-haematologists, so that they can initiate their own management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpretation of the results from the detection visit | Behavioral | - An interpretation of the results of the detection tests concerning
|
| Measure | Description | Time Frame |
|---|---|---|
| change from Baseline high blood pressure | blood pressure ≥ 140/90 mmHg measured in the investigating center and persisting over time | month 2, month 4, month 14 and month 24 |
| Change from Baseline chronic kidney failure incidence at 24 months | diagnosed on the basis of 2 blood tests carried out within 3 months with the same technique showing either:
The evolutionary character corresponds to one of the following situations:
| month 2, month 4, month 14 and month 24 |
| Change from Baseline chronic pain incidence at 60 months | pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) ≥ 3 | month 2, month 4, month 14 and month 24 |
| Change from Baseline sexual disorders incidence at 24 months | at least one perceived problem among the following:
| month 2, month 4, month 14 and month 24 |
| Change from Baseline osteoporosis incidence at 24 months | T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline depressive events incidence at 24 months | Defined by at least two main depressive symptoms, associated with at least two symptoms additional information, according to the 2017 HAS recommendation "Characterized depressive episode in adults : care in first resort". | month 2, month 4, month 14 and month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romain BUONO, PharmaD, MPH | Contact | +33469856358 | romain.buono@lyon.unicancer.fr | |
| Meyssane DJEBALI, Msc | Contact | ++33426556743 | meyssane.djebali@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mauricette MICHALLET, PhD, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy Genevois | Recruiting | Épagny | 74370 | France |
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|
| Explaining detection results and referrals to the patient | Behavioral | Explanation of results and directions to the patient using plain language;The aims of this call are as follows:
|
|
| Early medical care through the network | Behavioral | Early, proactive medical care through a network of dedicated healthcare professionals. |
|
| Transmission of results from each detection visit to the referring onco-haematologists - Control Group | Behavioral | For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective): all the data from each detection visit will be sent to the referring onco-haematologists, so that they can initiate their own management. |
|
| month 2, month 14 and month 24 |
| Change from Baseline chronic fatigue incidence at 24 months | Questionnaire "MFI-20" (Multidimensional Fatigue Inventory) | month 2, month 4, month 14 and month 24 |
| Change from Baseline severe anxiety disorder incidence at 24 months | Questionnaire "HADS-D" (Hospital Anxiety and Depression scale) | month 2, month 4, month 14 and month 24 |
| Change from Baseline physical deconditioning incidence at 24 months |
Defined by at least two tests among the 6 min Walk Test (TDM6), Handgrip-test, 60s Sit-to-stand, Flamingo test, with usual values below the norms defined by their authors, according to age and sex |
| month 2, month 14 and month 24 |
| Change from Baseline cognitive problems incidence at 24 months | Positive score on at least one of the sub-dimensions of the Functional questionnaire Cancer Therapy Assessment - Cognitive Function (FACT-COG) | month 2, month 14 and month 24 |
| Change from Baseline hypogonadism incidence at 24 months | Presence of clinical signs as defined by the International Society for Sexual Medicine A value below the lower limit on at least one of the following blood assay:
| month 2, month 14 and month 24 |
| Change from Baseline obesity incidence at 24 months | BMI value:
| month 2, month 14 and month 24 |
| Change from Baseline hypothyroidism incidence at 24 months |
| month 2, month 14 and month 24 |
| Change from Baseline dyslipidemias incidence at 24 months | hypercholesterolemia (LDL) ≥ 1.6 g/L estimated by the Friedewald formula and/or a hypertriglyceridemia ≥ 4 g/L | month 2, month 14 and month 24 |
| Change from Baseline Heart failure markers incidence at 24 months | NT-proBNP and/or troponin I level above the threshold values. | month 2, month 14 and month 24 |
| Change from Baseline Atrial fibrillation incidence at 24 months | equivocal electrocardiogram, interpreted by an experienced physician | month 2, month 14 and month 24 |
| Change from Baseline of respiratory failure markers incidence at 24 months | FVC, FVC, FEV1, FEF25-75, FEF50, FEF25 (established by spirometric test) ≤ 80% of the predicted values (abacus on age, sex, height and origin ethnic) | month 2, month 14 and month 24 |
| Change from Baseline return to work issues incidence at 24 months | Diagnosed by a social worker | month 2, month 14 and month 24 |
| Change from Baseline of Lifestyle risk factors ( tobacco, alcohol, and cannabis) incidence at 24 months | consumption :
| month 2, month 4, month 14 and month 24 |
| Change from baseline Myelodysplastic syndromes and secondary acute leukemia incidence at 24 months | confirmed by the reference diagnosis | month 4, month 14 and month 24 |
| CHU La Tronche | Recruiting | Grenoble | 38300 | France |
|
| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
|
| CENTRE HOSPITALIER UNIVERSITAIRE de MONTPELLIER | Recruiting | Montpellier | 34295 | France |
|
| CHU de St-Etienne | Recruiting | Saint-Etienne | France |
|
| Le Centre Hôpitaux Nord-Ouest Villefranche-sur-Saône | Recruiting | Villefranche-sur-Saône | 69655 | France |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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