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

N/AActive Not RecruitingNCT04671693

Centre Leon Berard500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Interventions

PASCA interventionOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of social precariousness

Diagnosed by a social worker

Time frame: Month 1

Change from Baseline return to work issues incidence at 60 months

Diagnosed by a social worker

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline cognitive problems incidence at 60 months

Diagnosed by a neurologist

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline anxiety crises incidence at 60 months

Diagnosed by a psychologist or psychiatrist

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline depressive events incidence at 60 months

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

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline physical deconditioning incidence at 60 months

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)

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline overweight/obesity incidence at 60 months

* BMI * Waist circumference

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline chronic pain incidence at 60 months

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

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline dermatological disorders incidence at 60 months

Common Terminology Criteria for Adverse Events (CTCAE) v5

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline gastrointestinal disorders incidence at 60 months

Common Terminology Criteria for Adverse Events (CTCAE) v5

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline sexual disorders incidence at 60 months

Questionnaire "Sexualité VICAN5"

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline hypogonadism incidence at 60 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: * level of total testosterone * level of bioavailable testosterone

Time frame: Month 1, Month 6, Month 24, Month 60

Change from 24 months premature ovarian failure incidence at 60 months

* level of Follicle stimulating hormone * level of estradiol

Time frame: Month 24, Month 60

Change from Baseline osteoporosis incidence at 60 months

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

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline chronic kidney failure incidence at 60 months

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.

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline heart failure incidence at 60 months

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

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline coronary heart disease incidence at 60 months

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

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline respiratory failure incidence at 60 months

* 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

Time frame: Month 1, Month 6, Month 24, Month 60

Change from Baseline hypothyroidism incidence at 60 months

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

Time frame: Month 1, Month 6, Month 24, Month 60

Secondary Outcomes

Evaluate the PASCA program: referrals made through the network

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

Time frame: Month 6, Month 24, Month 60

Evaluate the PASCA program: time between patient referral and completion of the first consultation

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

Time frame: Month 6, Month 24, Month 60

Evaluate the PASCA program: patients description

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

Time frame: Month 1, Month 6, Month 24, Month 60

Evaluation of the patient adherence

Ratio of the number of prescriptions issued for referral consultations /number of referral consultations actually attended by the patient

Time frame: Month 1, Month 6, Month 24, Month 60

Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.

* 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

Time frame: Month 6, Month 24, Month 60

Identification of risk factors associated with complications occurring during follow-up.

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

Time frame: Month 1, Month 6, Month 24, Month 60

Description of the Global Longitudinal Strain

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes