Clinical trial NCT04671693: A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Malakoff-Humanis
name: Fondation Apicil
name: Fédération Leucémie Espoir
name: Biogaran
name: Le défi Anthony
name: Novartis
name: Roche Pharma AG
First posted: 2020-12-17
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of social precariousness
timeFrame: Month 1
measure: Change from Baseline return to work issues incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline cognitive problems incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline anxiety crises incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline depressive events incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline chronic fatigue incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline physical deconditioning incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline overweight/obesity incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline chronic pain incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline dermatological disorders incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline gastrointestinal disorders incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline sexual disorders incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline hypogonadism incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from 24 months premature ovarian failure incidence at 60 months
timeFrame: Month 24, Month 60
measure: Change from Baseline osteoporosis incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline chronic kidney failure incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline heart failure incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline coronary heart disease incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline respiratory failure incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline hypothyroidism incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline lymphedema incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Change from Baseline second primary cancers incidence at 60 months
timeFrame: Month 1, Month 6, Month 24, Month 60
Secondary outcomes:
measure: Evaluate the PASCA program: referrals made through the network
timeFrame: Month 6, Month 24, Month 60
measure: Evaluate the PASCA program: time between patient referral and completion of the first consultation
timeFrame: Month 6, Month 24, Month 60
measure: Evaluate the PASCA program: patient characteristics
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Evaluation of the impact of program adherence on the evolution of the number of complications detected over time
timeFrame: Month 6, Month 24, Month 60
measure: Evaluation of the impact of program adherence on quality of life.
timeFrame: Month 6, Month 24, Month 60
measure: Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.
timeFrame: Month 6, Month 24, Month 60
measure: Identification of risk factors associated with complications occurring during follow-up.
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Description of the Global Longitudinal Strain
timeFrame: Month 6, Month 24, Month 60
measure: Description of the Left Ventricular Ejection Fraction
timeFrame: Month 6, Month 24, Month 60
measure: Description of the troponin I level
timeFrame: Month 6, Month 24, Month 60
measure: Description of the Glomerular Filtration Rate
timeFrame: Month 6, Month 24, Month 60
measure: Description of spirometry values
timeFrame: Month 6, Month 24, Month 60
measure: Incidence of diabetes mellitus
timeFrame: Month 6, Month 24, Month 60
measure: Incidence of untreated high blood pressure
timeFrame: Month 6, Month 24, Month 60
measure: Incidence of hypertriglyceridemia
timeFrame: Month 6, Month 24, Month 60
measure: Incidence of hyper-LDL-cholesterolemia
timeFrame: Month 6, Month 24, Month 60
measure: Incidence of low level of physical activity
timeFrame: Month 6, Month 24, Month 60
measure: Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)
timeFrame: Month 6, Month 24, Month 60
measure: Description of carcinogenic products consumption (tobacco, alcohol, cannabis)
timeFrame: Month 1, Month 6, Month 24, Month 60
measure: Evaluation of the Progression-free survival
timeFrame: Month 6, Month 24, Month 60
measure: Evaluation of the Survival without an increase in the number of complications, among those studied
timeFrame: Month 6, Month 24, Month 60
measure: Evaluation of the event-free survival
timeFrame: Month 6, Month 24, Month 60
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Leon Berard
Study officials:
affiliation: Centre Leon Berard
name: Mauricette MICHALLET, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: