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

Study of Complications Related to Treatments in Adults Aged 18 to 65 Years Old Responding to a First Treatment in Oncology or Onco-hematology and Participating in the PASCA (PArcours de Santé au Cours du CAncer) Post-treatment Program.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myeloid Leukemia; Hodgkin Disease; Osteosarcoma; Non Hodgkin Lymphoma; Late Effects; Ewing's Sarcoma; Testicular Germ Cell Tumor Mixed; Non-Metastatic Breast Carcinoma; Soft Tissue Sarcoma, Adult, Stage IIC
• Intervention / Treatment: Other: PASCA intervention

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69373
    • Centre Leon Berard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

1. males and females aged 18-65 years;
2. 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);
3. receiving first-line intensive chemotherapy;
4. 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;
5. No contraindications to adapted physical activity (APA) at inclusion;
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PASCA intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of social precariousness	Diagnosed by a social worker	Month 1
Change from Baseline return to work issues incidence at 60 months	Diagnosed by a social worker	Month 1, Month 6, Month 24, Month 60
Change from Baseline cognitive problems incidence at 60 months	Diagnosed by a neurologist	Month 1, Month 6, Month 24, Month 60
Change from Baseline anxiety crises incidence at 60 months	Diagnosed by a psychologist or psychiatrist	Month 1, Month 6, Month 24, Month 60
Change from Baseline depressive events incidence at 60 months	Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)	Month 1, Month 6, Month 24, Month 60
Change from Baseline physical deconditioning incidence at 60 months	A value below the lower limit on at least two of the following physical tests; Six-Minute Walk Test (6MWT) (meters); Hand Grip Strength Test (Kg); Five Times Sit to Stand Test (number); Flamingo Test (sec)	Month 1, Month 6, Month 24, Month 60
Change from Baseline overweight/obesity incidence at 60 months	BMI; Waist circumference	Month 1, Month 6, Month 24, Month 60
Change from Baseline chronic pain incidence at 60 months	Duration of pain; Questionnaire "DN4" (Douleur Neuropathique en 4 questions)	Month 1, Month 6, Month 24, Month 60
Change from Baseline dermatological disorders incidence at 60 months	Common Terminology Criteria for Adverse Events (CTCAE) v5	Month 1, Month 6, Month 24, Month 60
Change from Baseline gastrointestinal disorders incidence at 60 months	Common Terminology Criteria for Adverse Events (CTCAE) v5	Month 1, Month 6, Month 24, Month 60
Change from Baseline sexual disorders incidence at 60 months	Questionnaire "Sexualité VICAN5"	Month 1, Month 6, Month 24, Month 60
Change from Baseline hypogonadism incidence at 60 months	Presence of clinical signs as defined by the International Society for Sexual Medicine A value below the lower limit on at least one of the following blood assay: level of total testosterone; level of bioavailable testosterone	Month 1, Month 6, Month 24, Month 60
Change from 24 months premature ovarian failure incidence at 60 months	level of Follicle stimulating hormone; level of estradiol	Month 24, Month 60
Change from Baseline osteoporosis incidence at 60 months	T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur	Month 1, Month 6, Month 24, Month 60
Change from Baseline chronic kidney failure incidence at 60 months	Diagnosed on the basis of 2 blood tests within 3 months using the same technique showing a decrease in GFR to < 60ml/min/1.73m2, estimated from creatinine levels using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009), albuminuria or proteinuria positive, hematuria, leukocyturia > 10/mm3, or morphological abnormality on renal ultrasound.	Month 1, Month 6, Month 24, Month 60
Change from Baseline heart failure incidence at 60 months	Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate	Month 1, Month 6, Month 24, Month 60
Change from Baseline coronary heart disease incidence at 60 months	Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease	Month 1, Month 6, Month 24, Month 60
Change from Baseline respiratory failure incidence at 60 months	Forced Vital Capacity; Forced expiratory volume in 1 second; Vital capacity; Tiffeneau ratio; Peak expiratory flow; Total lung capacity; Diffusing Capacity Of The Lungs For Carbon Monoxide	Month 1, Month 6, Month 24, Month 60
Change from Baseline hypothyroidism incidence at 60 months	level of thyroid-stimulating hormone; level of total thyroxine	Month 1, Month 6, Month 24, Month 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the PASCA program: referrals made through the network	Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals)	Month 6, Month 24, Month 60
Evaluate the PASCA program: time between patient referral and completion of the first consultation	Average time (days) between patient referral and completion of the first consultation	Month 6, Month 24, Month 60
Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.	number of health professionals affiliated with the network; type of health professionals affiliated with the network; distribution over the Auvergne-Rhône-Alpes region according to medical speciality and department	Month 6, Month 24, Month 60
Identification of risk factors associated with complications occurring during follow-up.	Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up.	Month 1, Month 6, Month 24, Month 60
Description of the Global Longitudinal Strain	Evolution of the Global Longitudinal Strain in absolute value, relative to a later value	Month 6, Month 24, Month 60
Description of the troponin I level	Evolution of the troponin I level relative to a later value	Month 6, Month 24, Month 60
Description of the Glomerular Filtration Rate	Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value	Month 6, Month 24, Month 60
Description of spirometry values	Evolution of spirometry values relative to later values : Forced Vital Capacity; Forced expiratory volume in 1 second; Vital capacity; Tiffeneau ratio; Peak expiratory flow	Month 6, Month 24, Month 60
Incidence of diabetes mellitus	Level of fasting blood glucose	Month 6, Month 24, Month 60
Incidence of untreated high blood pressure	Measure of systolic blood pressure	Month 6, Month 24, Month 60
Incidence of hypertriglyceridemia	Level of triglyceridemia	Month 6, Month 24, Month 60
Incidence of hyper-LDL-cholesterolemia	Level of LDL-cholesterolemia	Month 6, Month 24, Month 60
Incidence of low level of physical activity	Questionnaire "Godin-Shephard Leisure-Time Physical Activity"	Month 6, Month 24, Month 60
Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)	Level of 25(OH) vitamin D (D2+D3)	Month 6, Month 24, Month 60
Description of carcinogenic products consumption (tobacco, alcohol, cannabis)	Number of packages years; Questionnaire "DETA-Cage"	Month 1, Month 6, Month 24, Month 60
Evaluation of the Progression-free survival	Evaluation of the Progression-free survival	Month 6, Month 24, Month 60
Evaluation of the Survival without an increase in the number of complications, among those studied	Evaluation of the Survival without an increase in the number of complications, among those studied	Month 6, Month 24, Month 60
Evaluation of the event-free survival	Evaluation of the event-free survival	Month 6, Month 24, Month 60
Evaluate the PASCA program: patients description	Comorbidities at diagnosis; Tumor classification; types and doses of each cancer treatments; ratio of the number of patients included / number of eligible patients	Month 1, Month 6, Month 24, Month 60
Evaluation of the patient adherence	Ratio of the number of prescriptions issued for referral consultations /number of referral consultations actually attended by the patient	Month 1, Month 6, Month 24, Month 60
identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up	measurement of the association between demographics, clinical cancer and treatment-related parameters and the occurence of a type of complication during the follow-up	Month 1, Month 6, Month 24 and Month 60

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: Novartis; Roche Pharma AG; Fondation Apicil; Malakoff-Humanis; Fédération Leucémie Espoir; Biogaran; Le défi Anthony
• Investigators: Principal Investigator: Mauricette MICHALLET, PhD, MD, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Estimated): January 24, 2029
• Study Completion (Estimated): April 24, 2029

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Adults; Screening; Osteosarcoma; Soft Tissue Sarcoma; Ewing's Sarcoma; Non Hodgkin Lymphoma; Survivors; Hodgkin Disease; Late Effects; Tertiary prevention; Testicular Germ Cell Tumor Mixed; Non-Metastatic Breast Carcinoma
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Leukemia, Myeloid; Neoplasms, Connective and Soft Tissue; Leukemia; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Sarcoma, Ewing; Lymphoma, Non-Hodgkin; Sarcoma; Hodgkin Disease; Osteosarcoma
• Other Study ID Numbers: PASCA; 2020-A01130-39 (Registry Identifier: IDRCB - French Agency for the Safety of Health Products)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No