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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change from 24 months premature ovarian failure incidence at 60 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from 24 months premature ovarian failure incidence at 60 months
时间窗: Month 24, Month 60
* level of Follicle stimulating hormone * level of estradiol
Change from Baseline osteoporosis incidence at 60 months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Month 1, Month 6, Month 24, Month 60
* level of thyroid-stimulating hormone * level of total thyroxine
Change from Baseline return to work issues incidence at 60 months
时间窗: Month 1, Month 6, Month 24, Month 60
Diagnosed by a social worker
Change from Baseline cognitive problems incidence at 60 months
时间窗: Month 1, Month 6, Month 24, Month 60
Diagnosed by a neurologist
Change from Baseline anxiety crises incidence at 60 months
时间窗: Month 1, Month 6, Month 24, Month 60
Diagnosed by a psychologist or psychiatrist
Change from Baseline depressive events incidence at 60 months
时间窗: 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
时间窗: 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
时间窗: Month 1, Month 6, Month 24, Month 60
* BMI * Waist circumference
Change from Baseline chronic pain incidence at 60 months
时间窗: 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
时间窗: Month 1, Month 6, Month 24, Month 60
Common Terminology Criteria for Adverse Events (CTCAE) v5
Incidence of social precariousness
时间窗: Month 1
Diagnosed by a social worker
Change from Baseline gastrointestinal disorders incidence at 60 months
时间窗: 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
时间窗: Month 1, Month 6, Month 24, Month 60
Questionnaire "Sexualité VICAN5"
Change from Baseline hypogonadism incidence at 60 months
时间窗: 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
Incidence of social precariousness
时间窗: Month 1
Diagnosed by a social worker
Change from Baseline return to work issues incidence at 60 months
时间窗: Month 1, Month 6, Month 24, Month 60
Diagnosed by a social worker
Change from Baseline cognitive problems incidence at 60 months
时间窗: Month 1, Month 6, Month 24, Month 60
Diagnosed by a neurologist
Change from Baseline anxiety crises incidence at 60 months
时间窗: Month 1, Month 6, Month 24, Month 60
Diagnosed by a psychologist or psychiatrist
Change from Baseline depressive events incidence at 60 months
时间窗: 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
时间窗: 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
时间窗: Month 1, Month 6, Month 24, Month 60
* BMI * Waist circumference
Change from Baseline chronic pain incidence at 60 months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Month 1, Month 6, Month 24, Month 60
Questionnaire "Sexualité VICAN5"
Change from Baseline hypogonadism incidence at 60 months
时间窗: 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
时间窗: Month 24, Month 60
* level of Follicle stimulating hormone * level of estradiol
Change from Baseline osteoporosis incidence at 60 months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Month 1, Month 6, Month 24, Month 60
* level of thyroid-stimulating hormone * level of total thyroxine
次要结局
- Description of the Global Longitudinal Strain(Month 6, Month 24, Month 60)
- Description of the troponin I level(Month 6, Month 24, Month 60)
- Description of the Glomerular Filtration Rate(Month 6, Month 24, Month 60)
- Evaluate the PASCA program: referrals made through the network(Month 6, Month 24, Month 60)
- Evaluate the PASCA program: time between patient referral and completion of the first consultation(Month 6, Month 24, Month 60)
- Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.(Month 6, Month 24, Month 60)
- Identification of risk factors associated with complications occurring during follow-up.(Month 1, Month 6, Month 24, Month 60)
- Description of spirometry values(Month 6, Month 24, Month 60)
- Incidence of diabetes mellitus(Month 6, Month 24, Month 60)
- Incidence of untreated high blood pressure(Month 6, Month 24, Month 60)
- Incidence of hypertriglyceridemia(Month 6, Month 24, Month 60)
- Incidence of hyper-LDL-cholesterolemia(Month 6, Month 24, Month 60)
- Incidence of low level of physical activity(Month 6, Month 24, Month 60)
- Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)(Month 6, Month 24, Month 60)
- Description of carcinogenic products consumption (tobacco, alcohol, cannabis)(Month 1, Month 6, Month 24, Month 60)
- Evaluation of the Progression-free survival(Month 6, Month 24, Month 60)
- Evaluation of the Survival without an increase in the number of complications, among those studied(Month 6, Month 24, Month 60)
- Evaluation of the event-free survival(Month 6, Month 24, Month 60)
- Evaluate the PASCA program: referrals made through the network(Month 6, Month 24, Month 60)
- Evaluate the PASCA program: time between patient referral and completion of the first consultation(Month 6, Month 24, Month 60)
- Evaluate the PASCA program: patients description(Month 1, Month 6, Month 24, Month 60)
- Evaluation of the patient adherence(Month 1, Month 6, Month 24, Month 60)
- Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.(Month 6, Month 24, Month 60)
- Identification of risk factors associated with complications occurring during follow-up.(Month 1, Month 6, Month 24, Month 60)
- Description of the Global Longitudinal Strain(Month 6, Month 24, Month 60)
- Description of the troponin I level(Month 6, Month 24, Month 60)
- Description of the Glomerular Filtration Rate(Month 6, Month 24, Month 60)
- Description of spirometry values(Month 6, Month 24, Month 60)
- Incidence of diabetes mellitus(Month 6, Month 24, Month 60)
- Incidence of untreated high blood pressure(Month 6, Month 24, Month 60)
- Incidence of hypertriglyceridemia(Month 6, Month 24, Month 60)
- Incidence of hyper-LDL-cholesterolemia(Month 6, Month 24, Month 60)
- Incidence of low level of physical activity(Month 6, Month 24, Month 60)
- Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)(Month 6, Month 24, Month 60)
- Description of carcinogenic products consumption (tobacco, alcohol, cannabis)(Month 1, Month 6, Month 24, Month 60)
- Evaluation of the Progression-free survival(Month 6, Month 24, Month 60)
- Evaluation of the Survival without an increase in the number of complications, among those studied(Month 6, Month 24, Month 60)
- Evaluation of the event-free survival(Month 6, Month 24, Month 60)
- identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up(Month 1, Month 6, Month 24 and Month 60)