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

Acute Myeloid Leukemia Clinical Trial

— PASCA  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04671693
• Other study ID #: PASCA
• Secondary ID: 2020-A01130-39
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: April 24, 2028

Study information

• Verified date: August 2023
• Source: Centre Leon Berard
• Contact: Romain BUONO, PharmD, MPH
• Phone: +33469856358
• Email: romain.buono[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 858
• Est. completion date: April 24, 2028
• Est. primary completion date: January 24, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years old and = 65 years old.

2. Follow-up at the Léon Bérard center

3. Treated by chemotherapy for one of the following pathologies, and confirmed by the reference diagnostic technique :

• acute myeloid leukemia;

• Hodgkin's lymphoma;

• aggressive non-Hodgkin's lymphoma;

• primary non-metastatic invasive breast carcinoma;

• testicular germ cell tumor treated with at least 3 courses of BEP (bleomycin, etoposide, cisplatin), 4 courses of EP (etoposide, cisplatin) or 4 courses of VIP (etoposide, ifosfamide, cisplatin) received;

• high-grade soft tissue sarcoma, osteosarcoma or Ewing's sarcoma.

4. As a complete response at the end of treatment consultation. If end-of-treatment evaluation is not available at the time of inclusion: as an assumed complete response in the opinion of the investigator based on the previous assessment of response.

5. Whose capacity to practice an adapted physical activity will have been certified by a medical certificate issued by the investigating physician, the general practitioner or the referring physician.

6. Able to understand, read and write French.

7. Available and willing to participate in the project throughout the duration of the study.

8. Living in the Auvergne-Rhône-Alpes region or in the department of Saône-et-Loire

9. Affiliated with a health insurance plan.

10. Having declared an attending physician.

11. Having signed and dated the informed consent.

Exclusion Criteria:

1. With a history of malignancy other than basal cell skin cancer.

2. Cannot be followed for medical, social, family, geographical or psychological reasons for the duration of the study.

3. Participating in other studies that could impact on the evaluation of the judgement criteria.

4. Deprived of liberty by judicial or administrative decision.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Breast Neoplasms
• Ewing's Sarcoma
• Hodgkin Disease
• Late Effects
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma, Non-Hodgkin
• Neoplasms, Germ Cell and Embryonal
• Non Hodgkin Lymphoma
• Non-Metastatic Breast Carcinoma
• Osteosarcoma
• Sarcoma
• Sarcoma, Ewing
• Soft Tissue Sarcoma, Adult, Stage IIC
• Testicular Germ Cell Tumor Mixed

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon

Sponsors (8)

Lead Sponsor	Collaborator
Centre Leon Berard	Biogaran, Fédération Leucémie Espoir, Fondation Apicil, Le défi Anthony, Malakoff-Humanis, Novartis, Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of social precariousness	Diagnosed by a social worker	Month 1
Primary	Change from Baseline return to work issues incidence at 60 months	Diagnosed by a social worker	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline cognitive problems incidence at 60 months	Diagnosed by a neurologist	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline anxiety crises incidence at 60 months	Diagnosed by a psychologist or psychiatrist	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline depressive events incidence at 60 months	Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline chronic fatigue incidence at 60 months	Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)	Month 1, Month 6, Month 24, Month 60
Primary	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)	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline overweight/obesity incidence at 60 months	BMI; Waist circumference	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline chronic pain incidence at 60 months	Duration of pain; Questionnaire "DN4" (Douleur Neuropathique en 4 questions)	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline dermatological disorders incidence at 60 months	Common Terminology Criteria for Adverse Events (CTCAE) v5	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline gastrointestinal disorders incidence at 60 months	Common Terminology Criteria for Adverse Events (CTCAE) v5	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline sexual disorders incidence at 60 months	Questionnaire "Sexualité VICAN5"	Month 1, Month 6, Month 24, Month 60
Primary	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	Month 1, Month 6, Month 24, Month 60
Primary	Change from 24 months premature ovarian failure incidence at 60 months	level of Follicle stimulating hormone; level of estradiol	Month 24, Month 60
Primary	Change from Baseline osteoporosis incidence at 60 months	T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur	Month 1, Month 6, Month 24, Month 60
Primary	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.	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline heart failure incidence at 60 months	Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate	Month 1, Month 6, Month 24, Month 60
Primary	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	Month 1, Month 6, Month 24, Month 60
Primary	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	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline hypothyroidism incidence at 60 months	level of thyroid-stimulating hormone; level of total thyroxine	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline lymphedema incidence at 60 months	Diagnosed by a vascular physician with a perimetric measurement of arms and forearms	Month 1, Month 6, Month 24, Month 60
Primary	Change from Baseline second primary cancers incidence at 60 months	Pathology report recorded in the patient file.	Month 1, Month 6, Month 24, Month 60
Secondary	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)	Month 6, Month 24, Month 60
Secondary	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	Month 6, Month 24, Month 60
Secondary	Evaluate the PASCA program: patient characteristics	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	Month 1, Month 6, Month 24, Month 60
Secondary	Evaluation of the impact of program adherence on the evolution of the number of complications detected over time	Measurement of the association between program adherence rate and the number of complications detected over time	Month 6, Month 24, Month 60
Secondary	Evaluation of the impact of program adherence on quality of life.	Measurement of the association between program adherence rate and the overall score on the secondary dimensions of quality of life.	Month 6, Month 24, Month 60
Secondary	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	Month 6, Month 24, Month 60
Secondary	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.	Month 1, Month 6, Month 24, Month 60
Secondary	Description of the Global Longitudinal Strain	Evolution of the Global Longitudinal Strain in absolute value, relative to a later value	Month 6, Month 24, Month 60
Secondary	Description of the Left Ventricular Ejection Fraction	Evolution of the Left Ventricular Ejection Fraction relative to a later value	Month 6, Month 24, Month 60
Secondary	Description of the troponin I level	Evolution of the troponin I level relative to a later value	Month 6, Month 24, Month 60
Secondary	Description of the Glomerular Filtration Rate	Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value	Month 6, Month 24, Month 60
Secondary	Description of spirometry values	Evolution of spirometry values relative to later values : Forced Vital Capacity; Forced expiratory volume in 1 second; Vital capacity; Tiffeneau ratio; Peak expiratory flow	Month 6, Month 24, Month 60
Secondary	Incidence of diabetes mellitus	Level of fasting blood glucose	Month 6, Month 24, Month 60
Secondary	Incidence of untreated high blood pressure	Measure of systolic blood pressure	Month 6, Month 24, Month 60
Secondary	Incidence of hypertriglyceridemia	Level of triglyceridemia	Month 6, Month 24, Month 60
Secondary	Incidence of hyper-LDL-cholesterolemia	Level of LDL-cholesterolemia	Month 6, Month 24, Month 60
Secondary	Incidence of low level of physical activity	Questionnaire "Godin-Shephard Leisure-Time Physical Activity"	Month 6, Month 24, Month 60
Secondary	Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)	Level of 25(OH) vitamin D (D2+D3)	Month 6, Month 24, Month 60
Secondary	Description of carcinogenic products consumption (tobacco, alcohol, cannabis)	Number of packages years; Questionnaire "DETA-Cage"	Month 1, Month 6, Month 24, Month 60
Secondary	Evaluation of the Progression-free survival	Evaluation of the Progression-free survival	Month 6, Month 24, Month 60
Secondary	Evaluation of the Survival without an increase in the number of complications, among those studied	Evaluation of the Survival without an increase in the number of complications, among those studied	Month 6, Month 24, Month 60
Secondary	Evaluation of the event-free survival	Evaluation of the event-free survival	Month 6, Month 24, Month 60