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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2028
  • participants needed
    858
  • sponsor
    Centre Leon Berard
Updated on 16 February 2021

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.

Details
Condition Hodgkin's Disease, Lymphoma, Ewing's sarcoma, Osteosarcoma, Acute myeloid leukemia, Lymphoma, Sarcoma, Non-Hodgkin's Lymphoma, Acute Myelogenous Leukemia (AML), Late Effects, Sarcoma (Pediatric), Soft Tissue Sarcoma, Late Effect, non-hodgkin's lymphoma (nhl), bone sarcoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, acute myelogenous leukemia, anll, acute myeloblastic leukemia, Testicular Germ Cell Tumor Mixed, Non-Metastatic Breast Carcinoma, Soft Tissue Sarcoma, Adult, Stage IIC, Non-Metastatic Breast Carcinoma, Soft Tissue Sarcoma, Adult, Stage IIC
Treatment PASCA intervention
Clinical Study IdentifierNCT04671693
SponsorCentre Leon Berard
Last Modified on16 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old and 65 years old
Follow-up at the Lon Brard center
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
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
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
Able to understand, read and write French
Available and willing to participate in the project throughout the duration of the study
Living in the Auvergne-Rhne-Alpes region or in the department of Sane-et-Loire
Affiliated with a health insurance plan
Having declared an attending physician
Having signed and dated the informed consent

Exclusion Criteria

With a history of malignancy other than basal cell skin cancer
Cannot be followed for medical, social, family, geographical or psychological reasons for the duration of the study
Participating in other studies that could impact on the evaluation of the judgement criteria
Deprived of liberty by judicial or administrative decision
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