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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04187118
Other study ID # RC31/19/0295
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 28, 2020
Est. completion date June 2025

Study information

Verified date September 2023
Source University Hospital, Toulouse
Contact Loïc YSEBAERT, MD, PhD
Phone 561145940
Email ysebaert.loic@iuct-oncopole.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Malignant lymphomas are considered as among the most chemo-sensitive cancers. ML are cured in more than 85% of patient, the majority with complete response. After this active phase of treatment, patients are in "after cancer period". Toulouse University Hospital developed since 2006 the Ambulatory Medical Assistance for After Cancer program on lymphoma patient. Ambulatory Medical Assistance for After Cancer is very efficient for detecting physical and psychological complications which impact quality of life. The investigators identified 22% of lymphoma patients who had a reduced quality of life one year after the end of chemotherapy. The present study aims to investigate the evolution of observed complications and identify cancer care pathway which decrease the quality of life reduction risk in patients one year after lymphoma chemotherapy.


Description:

Quality of life, as well anxiety, depression, social isolation, fear of cancer recurrence, post traumatic stress, will be measured in lymphoma patients, after a first line chemotherapy. Care cancer pathway will be also evaluated. Self-administered questionnaires will be performed on website (www.hospitalidee.fr) after inclusion and 12 months after.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date June 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients being in complete response after a first therapy for lymphoma - Malignant lymphoma (Hodgkin or non-Hodgkin) treated by anthracyclines with a minimum of 6 cycles, followed or not by autologous hematopoietic stem cell transplantation - Patients informed of the study and not opposed to the research Exclusion Criteria: - Patients under legal guardian . - Patients unavailable to formulate non-opposition to the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality of life
Quality of life one year post chemo-therapy

Locations

Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Toulouse Force Hémato, Hospitalidee

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life change: Quality of Life-C30 French version Health-related quality of life is evaluated by the use of Quality of Life-C30 French version Change from baseline quality of life at 12 month
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