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NCT Number: NCT04671693

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

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.

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Key information

Conditions

Late Effects Acute Myeloid Leukemia Ewing's Sarcoma Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Non Hodgkin Lymphoma Non-Metastatic Breast Carcinoma Osteosarcoma Sarcoma Sarcoma, Ewing Soft Tissue Sarcoma, Adult, Stage IIC Testicular Germ Cell Tumor Mixed

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Leon Berard

Lyon, 69373, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • males and females aged 18-65 years;
  • 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);
  • receiving first-line intensive chemotherapy;
  • 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;
  • No contraindications to adapted physical activity (APA) at inclusion;
  • 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.

Treatment and study plan

PASCA intervention

Other

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.

Primary outcomes

  1. Incidence of social precariousness

    Time frame: Month 1

    Diagnosed by a social worker

  2. Change from Baseline return to work issues incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Diagnosed by a social worker

  3. Change from Baseline cognitive problems incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Diagnosed by a neurologist

  4. Change from Baseline anxiety crises incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Diagnosed by a psychologist or psychiatrist

  5. Change from Baseline depressive events incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)

  6. Change from Baseline physical deconditioning incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    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)

  7. Change from Baseline overweight/obesity incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    • BMI
    • Waist circumference

  8. Change from Baseline chronic pain incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    • Duration of pain
    • Questionnaire "DN4" (Douleur Neuropathique en 4 questions)

  9. Change from Baseline dermatological disorders incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Common Terminology Criteria for Adverse Events (CTCAE) v5

  10. Change from Baseline gastrointestinal disorders incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Common Terminology Criteria for Adverse Events (CTCAE) v5

  11. Change from Baseline sexual disorders incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Questionnaire "Sexualité VICAN5"

  12. Change from Baseline hypogonadism incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    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

  13. Change from 24 months premature ovarian failure incidence at 60 months

    Time frame: Month 24, Month 60

    • level of Follicle stimulating hormone
    • level of estradiol

  14. Change from Baseline osteoporosis incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur

  15. Change from Baseline chronic kidney failure incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    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.

  16. Change from Baseline heart failure incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate

  17. Change from Baseline coronary heart disease incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease

  18. Change from Baseline respiratory failure incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    • 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

  19. Change from Baseline hypothyroidism incidence at 60 months

    Time frame: Month 1, Month 6, Month 24, Month 60

    • level of thyroid-stimulating hormone
    • level of total thyroxine

Secondary outcomes

  1. Evaluate the PASCA program: referrals made through the network

    Time frame: Month 6, Month 24, Month 60

    Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals)

  2. Evaluate the PASCA program: time between patient referral and completion of the first consultation

    Time frame: Month 6, Month 24, Month 60

    Average time (days) between patient referral and completion of the first consultation

  3. Evaluate the PASCA program: patients description

    Time frame: Month 1, Month 6, Month 24, Month 60

    • Comorbidities at diagnosis
    • Tumor classification
    • types and doses of each cancer treatments
    • ratio of the number of patients included / number of eligible patients

  4. Evaluation of the patient adherence

    Time frame: Month 1, Month 6, Month 24, Month 60

    Ratio of the number of prescriptions issued for referral consultations /number of referral consultations actually attended by the patient

  5. Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.

    Time frame: Month 6, Month 24, Month 60

    • 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

  6. Identification of risk factors associated with complications occurring during follow-up.

    Time frame: Month 1, Month 6, Month 24, Month 60

    Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up.

  7. Description of the Global Longitudinal Strain

    Time frame: Month 6, Month 24, Month 60

    Evolution of the Global Longitudinal Strain in absolute value, relative to a later value

  8. Description of the troponin I level

    Time frame: Month 6, Month 24, Month 60

    Evolution of the troponin I level relative to a later value

  9. Description of the Glomerular Filtration Rate

    Time frame: Month 6, Month 24, Month 60

    Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value

  10. Description of spirometry values

    Time frame: Month 6, Month 24, Month 60

    Evolution of spirometry values relative to later values :

    • Forced Vital Capacity
    • Forced expiratory volume in 1 second
    • Vital capacity
    • Tiffeneau ratio
    • Peak expiratory flow

  11. Incidence of diabetes mellitus

    Time frame: Month 6, Month 24, Month 60

    Level of fasting blood glucose

  12. Incidence of untreated high blood pressure

    Time frame: Month 6, Month 24, Month 60

    Measure of systolic blood pressure

  13. Incidence of hypertriglyceridemia

    Time frame: Month 6, Month 24, Month 60

    Level of triglyceridemia

  14. Incidence of hyper-LDL-cholesterolemia

    Time frame: Month 6, Month 24, Month 60

    Level of LDL-cholesterolemia

  15. Incidence of low level of physical activity

    Time frame: Month 6, Month 24, Month 60

    Questionnaire "Godin-Shephard Leisure-Time Physical Activity"

  16. Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)

    Time frame: Month 6, Month 24, Month 60

    Level of 25(OH) vitamin D (D2+D3)

  17. Description of carcinogenic products consumption (tobacco, alcohol, cannabis)

    Time frame: Month 1, Month 6, Month 24, Month 60

    • Number of packages years
    • Questionnaire "DETA-Cage"

  18. Evaluation of the Progression-free survival

    Time frame: Month 6, Month 24, Month 60

    Evaluation of the Progression-free survival

  19. Evaluation of the Survival without an increase in the number of complications, among those studied

    Time frame: Month 6, Month 24, Month 60

    Evaluation of the Survival without an increase in the number of complications, among those studied

  20. Evaluation of the event-free survival

    Time frame: Month 6, Month 24, Month 60

    Evaluation of the event-free survival

  21. identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up

    Time frame: Month 1, Month 6, Month 24 and Month 60

    measurement of the association between demographics, clinical cancer and treatment-related parameters and the occurence of a type of complication during the follow-up

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Biogaran
  • Fondation Apicil
  • Fédération Leucémie Espoir
  • Le défi Anthony
  • Malakoff-Humanis
  • Novartis
  • Roche Pharma AG

Registry information

Official study title

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.

Acronym: PASCA

Important dates

Study start
2020
Primary completion
2029
Study completion
2029
First posted
Dec 17, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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