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

NCT04671693 | Active Not Recruiting

• 2 other identifiers: PASCA2020-A01130-39
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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, 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

Keywords

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

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (21)

• Evaluate the PASCA program: referrals made through the network

  Month 6, Month 24, Month 60

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

  Month 6, Month 24, Month 60

• Evaluate the PASCA program: patients description

  Month 1, Month 6, Month 24, Month 60

• Evaluation of the patient adherence

  Month 1, Month 6, Month 24, Month 60

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

  Month 6, Month 24, Month 60

Study Arms (1)

PASCA intervention

EXPERIMENTAL

Other: PASCA intervention

Interventions

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.

PASCA intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Leon Berard: lead
• Malakoff-Humanis: collaborator
• Fondation Apicil: collaborator
• Fédération Leucémie Espoir: collaborator
• Biogaran: collaborator
• Le défi Anthony: collaborator
• Novartis: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Centre Leon Berard

Lyon, 69373, France

Location

MeSH Terms

Conditions

Sarcoma; Osteosarcoma; Sarcoma, Ewing; Leukemia, Myeloid, Acute; Hodgkin Disease; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Leukemia, Myeloid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mauricette MICHALLET, PhD, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: December 24, 2020
• Primary Completion (Estimated): January 24, 2029
• Study Completion (Estimated): April 24, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)