Neoplasms

Blood and Lymph Conditions

All Conditions

Skin and Connective Tissue Diseases

Immune System Diseases

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Carcinoma

Breast Neoplasms

Osteosarcoma

Sarcoma

Lymphoma

Hodgkin Disease

Sarcoma, Ewing

Lymphoma, Non-Hodgkin

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Neoplasms, Connective and Soft Tissue

Breast Diseases

Skin Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Soft Tissue Sarcoma

Lymphosarcoma

Hodgkin Lymphoma

Germ Cells Tumors

Acute Graft Versus Host Disease

Ewing Sarcoma

Testicular Germ Cell Tumor

At each study visit (T1 = 1 month, T2 = 6 months, T3 = 24 months, T4 = 60 months), an exhaustive screening of complications as well as associated sub-clinical abnormalities and risk factors previously identified as such in the literature, will be conducted.

Management of complications consists of referring the patient to a healthcare professional belonging to the PASCA network based on the test results. Referral is defined by referring to pre-established decision trees. It is made to a specialist physician, a health professional from the paramedical field or the patient's general practitioner who confirms the diagnosis if necessary and initiates the patient's care and follow-up. These patients also receive their usual follow-up in the context of their tumor pathology in oncology and onco-hematology.

PASCA intervention

Romain BUONO, PharmD, MPH

Meyssane DJEBALI, Msc

Mauricette MICHALLET, MD

Jean-Yves BLAY, MD

Thomas BACHELOT

Helen BOYLE

Aude FLECHON

Christelle DE LA FOUCHARDIERE

Pierre-Etienne HEUDEL

Pierre SAINTIGNY

Olivier TREDAN

Philippe TOUSSAINT

Mehdi BRAHMI

Alice BONNEVILLE-LEVARD

Armelle DUFRESNE

Anne-Sophie MICHALLET

Clemence SANTANA

Béatrice FERVERS

Marie Adele DAMMACCO

Christelle FAURE

Jean-François BRANTUS

Mellie HEINEMANN

Léa ROSSI

Violette MESDAG

Raphaelle PICARD

Nicolas CHOPIN

Mélodie CARBONNAUX

Philippe REY

Yann GUILLERMIN

Laure LEBRAS

Emmanuelle NICOLAS-VIRELIZIER

Amine BELHABRI

Souad ASSAAD

Franck-Emmanuel NICOLINI

Benoite MERY

Jessica SERRAND

Séverine RACADOT

Waisse WAISSI

Aude VISY

Paul POU

Clémence BONDU

Ronan TANGUY

Cécile LAUDE

Coralie MONCHARMONT

Christian CARRIE

Pierre MEEUS

François GOUIN

Armelle VINCENEUX

Mauricette MICHALLET, PhD, MD

INTRODUCTION: Approximately 44% of cancer survivors experience a deteriorated quality of life 5 years after diagnosis due to late onset of complications related to cancer treatments. The objective of the study is to evaluate the incidence rates of treatment-related complications, identify sub-clinical abnormalities and risk factors in patients participating in the PASCA post-treatment program.

METHOD: PASCA is a single-center, interventional cohort study of adult patients who received at least chemotherapy and with a complete remission to a testicular germ cell tumor, primary non-metastatic invasive breast carcinoma, high-grade soft tissue sarcoma, osteosarcoma, Ewing's sarcoma, acute myeloid leukemia, Hodgkin's or aggressive non-Hodgkin's lymphoma. Four assessment visits will be scheduled at 1 month (T1), 6 months (T2), 24 months (T3) and 60 months (T4) after completion of treatment. During these visits, 22 complications will be screened and follow-up care will be systematically offered to the health professional concerned by the complication in case of a positive result. The screening will contain the following elements: screening self-questionnaires, quality of life questionnaire, 12 biological parameters, a urinalysis evaluating hematuria, proteinuria, and leukocyturia, a spirometry, an electrocardiogram, 5 tests evaluating physical condition, vital signs and the perimetric measurement between both arms.

DISCUSSION: This systematic screening could highlight a number of complications occurring after cancer treatments. Sub-clinical abnormalities and new risk factors could also be identified. This new organization of care could improve the quality of life of adult cancer survivors.

All patients in the study will benefit from the PASCA post-treatment program with 4 visits : at 1 month (T1), 6 month (T2), 24 month (T3) and 60 month (T4) after the end of treatment.

A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors.

Study of Complications Related to Treatments in Adults Aged 18 to 65 Years Old Responding to a First Treatment in Oncology or Onco-hematology and Participating in the PASCA (PArcours de Santé au Cours du CAncer) Post-treatment Program.

Diagnosed by a psychologist or psychiatrist

Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)

Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)

A value below the lower limit on at least two of the following physical tests

* Six-Minute Walk Test (6MWT) (meters)
* Hand Grip Strength Test (Kg)
* Five Times Sit to Stand Test (number)
* Flamingo Test (sec)

* Duration of pain
* Questionnaire "DN4" (Douleur Neuropathique en 4 questions)

Common Terminology Criteria for Adverse Events (CTCAE) v5

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:

* level of total testosterone
* level of bioavailable testosterone

* level of Follicle stimulating hormone
* level of estradiol

T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur

Diagnosed on the basis of 2 blood tests within 3 months using the same technique showing a decrease in GFR to \< 60ml/min/1.73m2, estimated from creatinine levels using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009), albuminuria or proteinuria positive, hematuria, leukocyturia \> 10/mm3, or morphological abnormality on renal ultrasound.

Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate

Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease

* Forced Vital Capacity
* Forced expiratory volume in 1 second
* Vital capacity
* Tiffeneau ratio
* Peak expiratory flow
* Total lung capacity
* Diffusing Capacity Of The Lungs For Carbon Monoxide

* level of thyroid-stimulating hormone
* level of total thyroxine

Diagnosed by a vascular physician with a perimetric measurement of arms and forearms

Pathology report recorded in the patient file.

Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals)

Average time (days) between patient referral and completion of the first consultation

* Comorbidities at diagnosis
* Tumor classification
* cytogenetics mutations
* types and doses of each cancer treatments
* ratio of the number of patients included / number of eligible patients

Measurement of the association between program adherence rate and the number of complications detected over time

Measurement of the association between program adherence rate and the overall score on the secondary dimensions of quality of life.

* number of health professionals affiliated with the network
* type of health professionals affiliated with the network
* distribution over the Auvergne-Rhône-Alpes region according to medical speciality and department

Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up.

Evolution of the Global Longitudinal Strain in absolute value, relative to a later value

Evolution of the Left Ventricular Ejection Fraction relative to a later value

Evolution of the troponin I level relative to a later value

Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value

Evolution of spirometry values relative to later values :

* Forced Vital Capacity
* Forced expiratory volume in 1 second
* Vital capacity
* Tiffeneau ratio
* Peak expiratory flow

Questionnaire "Godin-Shephard Leisure-Time Physical Activity"

* Number of packages years
* Questionnaire "DETA-Cage"

Evaluation of the Progression-free survival

Evaluation of the Survival without an increase in the number of complications, among those studied

Spots Global Cancer Trial Database for soft tissue sarcoma, adult, stage iic