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

Léon Bérard Center

Status

Active, not recruiting

Conditions

Osteosarcoma

Testicular Germ Cell Tumor Mixed

Ewing's Sarcoma

Late Effects

Hodgkin Disease

Non-Metastatic Breast Carcinoma

Non Hodgkin Lymphoma

Soft Tissue Sarcoma, Adult, Stage IIC

Acute Myeloid Leukemia

Treatments

Other: PASCA intervention

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04671693

2020-A01130-39 (Registry Identifier)

PASCA

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

males and females aged 18-65 years;
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);
receiving first-line intensive chemotherapy;
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;
No contraindications to adapted physical activity (APA) at inclusion;
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.