Living Conditions After Non-Hodgkin's Lymphoma in France

NCT ID: NCT05583318

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1570 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-11-01

Brief Summary

This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Patients will be selected from the three specialized hematology registries in France: Côte-d'Or, Gironde and Basse-Normandie.

This is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large B-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. In addition, the proportion of cured patients will be estimated.

For component 1, this will be the survival analysis on the initial data. For part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. There is no physical interview nor any specific biological or imaging examination.

Conditions

Non-hodgkin's Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Part 1: Patients diagnosed with non-Hodgkin's lymphoma

Diagnosis period 2010-2018, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie

Data collection

Intervention Type: OTHER

Data from hematological malignancy registries

Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update

Update of vital status in December 2022

Questionnaires

Intervention Type: OTHER

9 questionnaires were sent out:

1. QLQ-C30 and SF-12 Quality of Life Questionnaire.

2. Oral quality of life questionnaire QLQ-OH15

3. Sexuality questionnaire SHQ-C22

4. Anxiety and depression questionnaire HADS,

5. Rosenberg Self-Esteem Questionnaire

6. RNLI Reintegration to Normal Life Questionnaire

7. Social Support Questionnaire SSQ6,

8. Socio-economic status questionnaire EPICES,

9. Complementary questionnaire collecting data on socio-professional status.

Interventions

Data collection

Data from hematological malignancy registries

Intervention Type: OTHER

Questionnaires

9 questionnaires were sent out:

1. QLQ-C30 and SF-12 Quality of Life Questionnaire.

2. Oral quality of life questionnaire QLQ-OH15

3. Sexuality questionnaire SHQ-C22

4. Anxiety and depression questionnaire HADS,

5. Rosenberg Self-Esteem Questionnaire

6. RNLI Reintegration to Normal Life Questionnaire

7. Social Support Questionnaire SSQ6,

8. Socio-economic status questionnaire EPICES,

9. Complementary questionnaire collecting data on socio-professional status.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis period 2010-2018, according to the 2008 WHO ICD-O-3 classification, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie
• Patients with a diagnosis of follicular lymphoma (9690/3, 9691/3, 9695/3, 9698/3, 9597/3)
• Patients with a diagnosis of diffuse large B-cell lymphoma (9678/3, 9679/3, 9680/3, 9684/3, 9688/3, 9712/3, 9735/3, 9737/3, 9738/3)
• For Part 2: Individuals alive at the date of vital status update

• Other forms of malignant hemopathies at diagnosis,
• Minors.

Exclusion Criteria

• Person under a legal protection measure (curatorship, guardianship)
• Person under a legal protection measure (guardianship, tutorship)
• Pregnant, parturient or breastfeeding women
• Major incapable or unable to express his consent
• Person who did not return the questionnaires following the 1-month follow-up, or patient who expressed refusal to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

MAYNADIE 2022

Identifier Type: -

Identifier Source: org_study_id