Acute Myeloid Leukemia, Ewing's Sarcoma, Hodgkin Disease, Late Effects, Non Hodgkin Lymphoma, Non-Metastatic Breast Carcinoma, Osteosarcoma, Soft Tissue Sarcoma, Adult, Stage IIC, Testicular Germ Cell Tumor Mixed
Conditions
Keywords
Late Effects, Survivors, Adults, Screening, Tertiary prevention, Testicular Germ Cell Tumor Mixed, Non-Metastatic Breast Carcinoma, Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, Acute Myeloid Leukemia, Hodgkin Disease, Non Hodgkin Lymphoma
Brief summary
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, 19 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.
Interventions
OTHERPASCA intervention
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.
Sponsors
Malakoff-Humanis
Fondation Apicil
Fédération Leucémie Espoir
Biogaran
Le défi Anthony
Novartis
Roche Pharma AG
Centre Leon Berard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. males and females aged 18-65 years; 2. Diagnosis and management at CLB for one of the following cancers: Hodgkin's lymphoma, aggressive non-Hodgkin's lymphoma, acute myeloid leukemia and primary non metastatic invasive breast cancer (BC), TGCT, or Sarcoma (Soft Tissue Sarcoma, Osteosarcoma, and Ewing's Sarcoma); 3. receiving first-line intensive chemotherapy; 4. with a complete response status at the end of the last treatment, which may include chemotherapy (excluding maintenance and hormone therapy), radiotherapy or adjuvant surgery, depending on the last scheduled treatment; 5. No contraindications to adapted physical activity (APA) at inclusion; 6. no medical, social, family, or psychological barriers against study participation. Patients will be excluded if they have a history or coexistence of another primary cancer (except basal cell skin cancer), are participating in another study affecting the primary outcome, are deprived of liberty, or reside outside the Auvergne-Rhône-Alpes region or the Saône-et-Loire department.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline hypothyroidism incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | * level of thyroid-stimulating hormone * level of total thyroxine |
| Incidence of social precariousness | Month 1 | Diagnosed by a social worker |
| Change from Baseline return to work issues incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Diagnosed by a social worker |
| Change from Baseline cognitive problems incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Diagnosed by a neurologist |
| Change from Baseline anxiety crises incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Diagnosed by a psychologist or psychiatrist |
| Change from Baseline depressive events incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Questionnaire HADS-D (Hospital Anxiety and Depression scale) |
| Change from Baseline physical deconditioning incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | 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) |
| Change from Baseline overweight/obesity incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | * BMI * Waist circumference |
| Change from Baseline chronic pain incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | * Duration of pain * Questionnaire DN4 (Douleur Neuropathique en 4 questions) |
| Change from Baseline dermatological disorders incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Common Terminology Criteria for Adverse Events (CTCAE) v5 |
| Change from Baseline gastrointestinal disorders incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Common Terminology Criteria for Adverse Events (CTCAE) v5 |
| Change from Baseline sexual disorders incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Questionnaire Sexualité VICAN5 |
| Change from Baseline hypogonadism incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | 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 |
| Change from 24 months premature ovarian failure incidence at 60 months | Month 24, Month 60 | * level of Follicle stimulating hormone * level of estradiol |
| Change from Baseline osteoporosis incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur |
| Change from Baseline chronic kidney failure incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | 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. |
| Change from Baseline heart failure incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate |
| Change from Baseline coronary heart disease incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease |
| Change from Baseline respiratory failure incidence at 60 months | Month 1, Month 6, Month 24, Month 60 | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the event-free survival | Month 6, Month 24, Month 60 | Evaluation of the event-free survival |
| Evaluate the PASCA program: referrals made through the network | Month 6, Month 24, Month 60 | Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals) |
| identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up | Month 1, Month 6, Month 24 and Month 60 | measurement of the association between demographics, clinical cancer and treatment-related parameters and the occurence of a type of complication during the follow-up |
| Evaluate the PASCA program: time between patient referral and completion of the first consultation | Month 6, Month 24, Month 60 | Average time (days) between patient referral and completion of the first consultation |
| Evaluate the PASCA program: patients description | Month 1, Month 6, Month 24, Month 60 | * Comorbidities at diagnosis * Tumor classification * types and doses of each cancer treatments * ratio of the number of patients included / number of eligible patients |
| Evaluation of the patient adherence | Month 1, Month 6, Month 24, Month 60 | Ratio of the number of prescriptions issued for referral consultations /number of referral consultations actually attended by the patient |
| Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues. | Month 6, Month 24, Month 60 | * 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 |
| Identification of risk factors associated with complications occurring during follow-up. | Month 1, Month 6, Month 24, Month 60 | Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up. |
| Description of the Global Longitudinal Strain | Month 6, Month 24, Month 60 | Evolution of the Global Longitudinal Strain in absolute value, relative to a later value |
| Description of the troponin I level | Month 6, Month 24, Month 60 | Evolution of the troponin I level relative to a later value |
| Description of the Glomerular Filtration Rate | Month 6, Month 24, Month 60 | Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value |
| Description of spirometry values | Month 6, Month 24, Month 60 | Evolution of spirometry values relative to later values : * Forced Vital Capacity * Forced expiratory volume in 1 second * Vital capacity * Tiffeneau ratio * Peak expiratory flow |
| Incidence of diabetes mellitus | Month 6, Month 24, Month 60 | Level of fasting blood glucose |
| Incidence of untreated high blood pressure | Month 6, Month 24, Month 60 | Measure of systolic blood pressure |
| Incidence of hypertriglyceridemia | Month 6, Month 24, Month 60 | Level of triglyceridemia |
| Incidence of hyper-LDL-cholesterolemia | Month 6, Month 24, Month 60 | Level of LDL-cholesterolemia |
| Incidence of low level of physical activity | Month 6, Month 24, Month 60 | Questionnaire Godin-Shephard Leisure-Time Physical Activity |
| Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3) | Month 6, Month 24, Month 60 | Level of 25(OH) vitamin D (D2+D3) |
| Description of carcinogenic products consumption (tobacco, alcohol, cannabis) | Month 1, Month 6, Month 24, Month 60 | * Number of packages years * Questionnaire DETA-Cage |
| Evaluation of the Progression-free survival | Month 6, Month 24, Month 60 | Evaluation of the Progression-free survival |
| Evaluation of the Survival without an increase in the number of complications, among those studied | Month 6, Month 24, Month 60 | Evaluation of the Survival without an increase in the number of complications, among those studied |
Countries
France
Outcome results
None listed