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

Condition(s) studied

Investigational drug(s) / intervention(s)

PASCA 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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
• 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

Trial sites (1)

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