Study of Treatment Complications in Oncology / Hematology Patients: Protocol for a Prospective and Interventional Cohort Study from the Pasca Program
Authors: Michallet Mauricette , Buono Romain , Sobh Mohamad , Poirey Solene , Nicolas-Virelizier Emmanuelle , Assaad Souad , Belhabri Amine , Lebras Laure , Guillermin Yann , Rey Philippe , Flechon Aude , Boyle Helen , Nicolini Franck E , Couillet Audrey , Chvetzoff Gisele , Blay Jean-Yves , Fervers Beatrice , Michallet Anne-Sophie 
Published: February 2021

Introduction
In France, cancer incidence is increasing, reaching approximately 400,000 new cases in 2017. Thanks to diagnostic and therapeutic advances, net survival at 5 years is improving, with a corollary increase in the number of survivors. Among survivors, 44% have a poor quality of life due to the more or less late onset of treatment-related complications. Despite the objectives of the 2014-2019 national cancer plan considering the latest therapeutic advances, very few initiatives integrating systematic, early detection and management of complications exist in France.
Methods and analysis
PASCA (Care pathways through cancer) is a single-arm, interdisciplinary, prospective, interventional, cohort study. During a period of 24 months, it is intended to include 858 adults aged 18 to 65 years with non-Hodgkin and Hodgkin lymphoma, acute myeloid leukemia, testicular germ cell tumor, non-metastatic invasive breast cancer, soft tissue sarcoma, osteosarcoma or Ewing's sarcoma at Centre Leon Berard (Lyon, France). The program consists on exhaustive identification of 22 complications at 1 month, 6 months, 24 months and 60 months after the end of first line treatment: social precariousness, return-to-work issues, cognitive problems, anxiety and depression disorders, chronic fatigue, physical deconditioning, overweight/obesity, chronic pain, dermatological disorders, gastrointestinal disorders, sexual disorders, hypogonadism, premature ovarian failure, osteoporosis, chronic kidney failure, heart failure, coronary heart disease, respiratory failure, hypothyroidism, lymphedema, modifiable risk factors associated with the occurrence of secondary cancers. Each identification will give rise to management, which consists of referring the patient to a healthcare professional belonging to the network of dedicated healthcare professionals at the regional level. The course of action to be followed will be defined using decision trees based on international, national or learned society recommendations. Referral outside Centre Leon Berard will be made to a specialist doctor, a health professional from the paramedical field or the patient's general practitioner who will confirm the diagnosis and initiate patient management and follow-up. These patients will also benefit from their usual follow-up in the context of their initial malignancy. Each study visit will include a search for clinical signs using questionnaires, an assay of 12 biological parameters, a urine test strip, 5 tests evaluating physical deconditioning and an electrocardiogram. The weight, height, waist circumference, blood pressure will also be measured. Primary outcome will be the incidence of the 22 complications, measured at 1 month, 6 months, 24 months and 60 months after the end of intensive chemotherapy treatment.
Ethics and dissemination
The study protocol was approved by the French ethics committee (Comité de protection des personnes Ile de France IV), the study database is currently being declared and registered to the Commission Nationale de l'Informatique et des Libertés (CNIL) and the study on ClinicalTrials.gov. The results will be disseminated to patients and in peer-reviewed journals and academic conferences.
Strengths and limitations of this study This study is based on a previous feasibility study with 52 patients recruited in onco-hematology, which demonstrated the feasibility of the intervention and the existence of patient management needs.(1)
The study design does not include a comparator arm, as the objective of the study is to provide a comprehensive picture of treatment-related complications, especially those that appear over the long term.
Due to the lack of recent data concerning some complications, sample size was calculated empirically on the basis of the active queue of patients at the Centre Leon Berard.
References Michallet M, Sobh M, Buono R, Poirey S, Pascu I, Nicolas-Virelizier E, et al. Personalised Follow-up Program after Acute Phase of Treatment in Oncology/Hematology Patients Towards Early Intervention, Better Care and Quality of Life Improvement: Results from Pasca Pilot Study. Blood. 13 nov 2019;134(Supplement_1):5817-5817.

Disclosures
Nicolini: Sun Pharma Ltd: Consultancy; Incyte: Research Funding, Speakers Bureau; Novartis: Research Funding, Speakers Bureau.