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

Not Applicable

Recruiting

• Conditions: Non-Metastatic Breast Carcinoma; Soft Tissue Sarcoma, Adult, Stage IIC; Late Effects; Ewing's Sarcoma; Acute Myeloid Leukemia; Non Hodgkin Lymphoma; Testicular Germ Cell Tumor Mixed; Hodgkin Disease; Osteosarcoma
• Interventions: Other: PASCA intervention

• Registration Number: NCT04671693
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Study Start: 2020-12-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2028-01-24
• Study Completion: 2028-04-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 858

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PASCA intervention	PASCA intervention	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline cognitive problems incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Diagnosed by a neurologist
Change from Baseline depressive events incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)
Change from 24 months premature ovarian failure incidence at 60 months	Month 24, Month 60	* level of Follicle stimulating hormone; * level of estradiol
Change from Baseline sexual disorders incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Questionnaire "Sexualité VICAN5"
Change from Baseline anxiety crises incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Diagnosed by a psychologist or psychiatrist
Change from Baseline physical deconditioning incidence at 60 months	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)
Change from Baseline heart failure incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate
Change from Baseline return to work issues incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Diagnosed by a social worker
Change from Baseline chronic pain incidence at 60 months	Month 1, Month 6, Month 24, Month 60	* Duration of pain; * Questionnaire "DN4" (Douleur Neuropathique en 4 questions)
Change from Baseline hypogonadism incidence at 60 months	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
Change from Baseline osteoporosis incidence at 60 months	Month 1, Month 6, Month 24, Month 60	T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur
Change from Baseline coronary heart disease incidence at 60 months	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
Change from Baseline respiratory failure incidence at 60 months	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
Incidence of social precariousness	Month 1	Diagnosed by a social worker
Change from Baseline chronic fatigue incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)
Change from Baseline overweight/obesity incidence at 60 months	Month 1, Month 6, Month 24, Month 60	* BMI; * Waist circumference
Change from Baseline dermatological disorders incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Common Terminology Criteria for Adverse Events (CTCAE) v5
Change from Baseline gastrointestinal disorders incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Common Terminology Criteria for Adverse Events (CTCAE) v5
Change from Baseline hypothyroidism incidence at 60 months	Month 1, Month 6, Month 24, Month 60	* level of thyroid-stimulating hormone; * level of total thyroxine
Change from Baseline lymphedema incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Diagnosed by a vascular physician with a perimetric measurement of arms and forearms
Change from Baseline second primary cancers incidence at 60 months	Month 1, Month 6, Month 24, Month 60	Pathology report recorded in the patient file.
Change from Baseline chronic kidney failure incidence at 60 months	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of low level of physical activity	Month 6, Month 24, Month 60	Questionnaire "Godin-Shephard Leisure-Time Physical Activity"
Evaluation of the impact of program adherence on quality of life.	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.
Description of the Left Ventricular Ejection Fraction	Month 6, Month 24, Month 60	Evolution of the Left Ventricular Ejection Fraction relative to a later value
Incidence of diabetes mellitus	Month 6, Month 24, Month 60	Level of fasting blood glucose
Incidence of hypertriglyceridemia	Month 6, Month 24, Month 60	Level of triglyceridemia
Incidence of hyper-LDL-cholesterolemia	Month 6, Month 24, Month 60	Level of LDL-cholesterolemia
Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)	Month 6, Month 24, Month 60	Level of 25(OH) vitamin D (D2+D3)
Evaluate the PASCA program: time between patient referral and completion of the first consultation	Month 6, Month 24, Month 60	Average time (days) between patient referral and completion of the first consultation
Evaluation of the event-free survival	Month 6, Month 24, Month 60	Evaluation of the event-free survival
Evaluate the PASCA program: referrals made through the network	Month 6, Month 24, Month 60	Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals)
Evaluation of the impact of program adherence on the evolution of the number of complications detected over time	Month 6, Month 24, Month 60	Measurement of the association between program adherence rate and the number of complications detected over time
Identification of risk factors associated with complications occurring during follow-up.	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.
Description of the Global Longitudinal Strain	Month 6, Month 24, Month 60	Evolution of the Global Longitudinal Strain in absolute value, relative to a later value
Evaluate the PASCA program: patient characteristics	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
Description of spirometry values	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
Description of carcinogenic products consumption (tobacco, alcohol, cannabis)	Month 1, Month 6, Month 24, Month 60	* Number of packages years; * Questionnaire "DETA-Cage"
Evaluation of the Survival without an increase in the number of complications, among those studied	Month 6, Month 24, Month 60	Evaluation of the Survival without an increase in the number of complications, among those studied
Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.	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
Description of the Glomerular Filtration Rate	Month 6, Month 24, Month 60	Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value
Description of the troponin I level	Month 6, Month 24, Month 60	Evolution of the troponin I level relative to a later value
Incidence of untreated high blood pressure	Month 6, Month 24, Month 60	Measure of systolic blood pressure
Evaluation of the Progression-free survival	Month 6, Month 24, Month 60	Evaluation of the Progression-free survival

Trial Locations

Locations (1)

Centre Leon Berard; 🇫🇷 Lyon, France