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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04671693
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : March 16, 2022
Sponsor:
Collaborators:
Malakoff-Humanis
Fondation Apicil
Fédération Leucémie Espoir
Biogaran
Le défi Anthony
Novartis
Roche Pharma AG
Information provided by (Responsible Party):
Centre Leon Berard

Brief 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.


Condition or disease Intervention/treatment Phase
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 Other: PASCA intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 858 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients in the study will benefit from the PASCA post-treatment program with 4 visits : at 1 month (T1), 6 month (T2), 24 month (T3) and 60 month (T4) after the end of treatment.
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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.
Actual Study Start Date : December 24, 2020
Estimated Primary Completion Date : January 24, 2028
Estimated Study Completion Date : April 24, 2028


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.





Primary Outcome Measures :
  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 chronic fatigue incidence at 60 months [ Time Frame: Month 1, Month 6, Month 24, Month 60 ]
    Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)

  7. 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)

  8. Change from Baseline overweight/obesity incidence at 60 months [ Time Frame: Month 1, Month 6, Month 24, Month 60 ]
    • BMI
    • Waist circumference

  9. 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)

  10. 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

  11. 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

  12. Change from Baseline sexual disorders incidence at 60 months [ Time Frame: Month 1, Month 6, Month 24, Month 60 ]
    Questionnaire "Sexualité VICAN5"

  13. 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

  14. 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

  15. 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

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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

  21. Change from Baseline lymphedema incidence at 60 months [ Time Frame: Month 1, Month 6, Month 24, Month 60 ]
    Diagnosed by a vascular physician with a perimetric measurement of arms and forearms

  22. Change from Baseline second primary cancers incidence at 60 months [ Time Frame: Month 1, Month 6, Month 24, Month 60 ]
    Pathology report recorded in the patient file.


Secondary Outcome Measures :
  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: patient characteristics [ Time Frame: Month 1, Month 6, Month 24, Month 60 ]
    • Comorbidities at diagnosis
    • Tumor classification
    • cytogenetics mutations
    • types and doses of each cancer treatments
    • ratio of the number of patients included / number of eligible patients

  4. Evaluation of the impact of program adherence on the evolution of the number of complications detected over time [ Time Frame: Month 6, Month 24, Month 60 ]
    Measurement of the association between program adherence rate and the number of complications detected over time

  5. Evaluation of the impact of program adherence on quality of life. [ Time Frame: Month 6, Month 24, Month 60 ]
    Measurement of the association between program adherence rate and the overall score on the secondary dimensions of quality of life.

  6. 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

  7. 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.

  8. 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

  9. Description of the Left Ventricular Ejection Fraction [ Time Frame: Month 6, Month 24, Month 60 ]
    Evolution of the Left Ventricular Ejection Fraction relative to a later value

  10. 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

  11. 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

  12. 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

  13. Incidence of diabetes mellitus [ Time Frame: Month 6, Month 24, Month 60 ]
    Level of fasting blood glucose

  14. Incidence of untreated high blood pressure [ Time Frame: Month 6, Month 24, Month 60 ]
    Measure of systolic blood pressure

  15. Incidence of hypertriglyceridemia [ Time Frame: Month 6, Month 24, Month 60 ]
    Level of triglyceridemia

  16. Incidence of hyper-LDL-cholesterolemia [ Time Frame: Month 6, Month 24, Month 60 ]
    Level of LDL-cholesterolemia

  17. Incidence of low level of physical activity [ Time Frame: Month 6, Month 24, Month 60 ]
    Questionnaire "Godin-Shephard Leisure-Time Physical Activity"

  18. 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)

  19. 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"

  20. Evaluation of the Progression-free survival [ Time Frame: Month 6, Month 24, Month 60 ]
    Evaluation of the Progression-free survival

  21. 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

  22. Evaluation of the event-free survival [ Time Frame: Month 6, Month 24, Month 60 ]
    Evaluation of the event-free survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old and ≤ 65 years old.
  2. Follow-up at the Léon Bérard center
  3. 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.
  4. 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.
  5. 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.
  6. Able to understand, read and write French.
  7. Available and willing to participate in the project throughout the duration of the study.
  8. Living in the Auvergne-Rhône-Alpes region or in the department of Saône-et-Loire
  9. Affiliated with a health insurance plan.
  10. Having declared an attending physician.
  11. Having signed and dated the informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671693


Contacts
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Contact: Romain BUONO, PharmD, MPH +33469856358 romain.buono@lyon.unicancer.fr
Contact: Meyssane DJEBALI, Msc +33469856358 meyssane.djebali@lyon.unicancer.fr

Locations
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France
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Mauricette MICHALLET, MD    +33469856358    mauricette.michallet@lyon.unicancer.fr   
Sub-Investigator: Jean-Yves BLAY, MD         
Sub-Investigator: Thomas BACHELOT         
Sub-Investigator: Helen BOYLE         
Sub-Investigator: Aude FLECHON         
Sub-Investigator: Christelle DE LA FOUCHARDIERE         
Sub-Investigator: Pierre-Etienne HEUDEL         
Sub-Investigator: Pierre SAINTIGNY         
Sub-Investigator: Olivier TREDAN         
Sub-Investigator: Philippe TOUSSAINT         
Sub-Investigator: Mehdi BRAHMI         
Sub-Investigator: Alice BONNEVILLE-LEVARD         
Sub-Investigator: Armelle DUFRESNE         
Sub-Investigator: Anne-Sophie MICHALLET         
Sub-Investigator: Clemence SANTANA         
Sub-Investigator: Béatrice FERVERS         
Sub-Investigator: Marie Adele DAMMACCO         
Sub-Investigator: Christelle FAURE         
Sub-Investigator: Jean-François BRANTUS         
Sub-Investigator: Mellie HEINEMANN         
Sub-Investigator: Léa ROSSI         
Sub-Investigator: Violette MESDAG         
Sub-Investigator: Raphaelle PICARD         
Sub-Investigator: Nicolas CHOPIN         
Sub-Investigator: Mélodie CARBONNAUX         
Sub-Investigator: Philippe REY         
Sub-Investigator: Yann GUILLERMIN         
Sub-Investigator: Laure LEBRAS         
Sub-Investigator: Emmanuelle NICOLAS-VIRELIZIER         
Sub-Investigator: Amine BELHABRI         
Sub-Investigator: Souad ASSAAD         
Sub-Investigator: Franck-Emmanuel NICOLINI         
Sub-Investigator: Benoite MERY         
Sub-Investigator: Jessica SERRAND         
Sub-Investigator: Séverine RACADOT         
Sub-Investigator: Waisse WAISSI         
Sub-Investigator: Aude VISY         
Sub-Investigator: Paul POU         
Sub-Investigator: Clémence BONDU         
Sub-Investigator: Ronan TANGUY         
Sub-Investigator: Cécile LAUDE         
Sub-Investigator: Coralie MONCHARMONT         
Sub-Investigator: Christian CARRIE         
Sub-Investigator: Pierre MEEUS         
Sub-Investigator: François GOUIN         
Sub-Investigator: Armelle VINCENEUX         
Sponsors and Collaborators
Centre Leon Berard
Malakoff-Humanis
Fondation Apicil
Fédération Leucémie Espoir
Biogaran
Le défi Anthony
Novartis
Roche Pharma AG
Investigators
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Principal Investigator: Mauricette MICHALLET, PhD, MD Centre Leon Berard
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04671693    
Other Study ID Numbers: PASCA
2020-A01130-39 ( Registry Identifier: IDRCB - French Agency for the Safety of Health Products )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
Late Effects
Survivors
Adults
Screening
Tertiary prevention
Testicular Germ Cell Tumor Mixed
Non-Metastatic Breast Carcinoma
Soft Tissue Sarcoma
Osteosarcoma
Ewing's Sarcoma
Acute Myeloid Leukemia
Hodgkin Disease
Non Hodgkin Lymphoma
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Sarcoma
Lymphoma, Non-Hodgkin
Neoplasms, Germ Cell and Embryonal
Breast Neoplasms
Osteosarcoma
Sarcoma, Ewing
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue