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

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, 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.

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.