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

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, 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Malakoff-Humanis

  collaborator UNKNOWN

• Fondation Apicil

  collaborator OTHER

• Fédération Leucémie Espoir

  collaborator UNKNOWN

• Biogaran

  collaborator UNKNOWN

• Le défi Anthony

  collaborator UNKNOWN

• Novartis

  collaborator INDUSTRY

• Roche Pharma AG

  collaborator INDUSTRY

• Centre Leon Berard

  lead OTHER

Principal Investigators

• Mauricette MICHALLET, PhD, MD · Centre Leon Berard

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-24

Primary Completion

2029-01-24

Completion

2029-04-24

Countries

• France

Study Locations