LymphoVie 2: Living Conditions After Non-Hodgkin's Lymphoma in France
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Other: Data collection
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 |
Other: Questionnaires
9 questionnaires were sent out:
QLQ-C30 and SF-12 Quality of Life Questionnaire.
Oral quality of life questionnaire QLQ-OH15
Sexuality questionnaire SHQ-C22
Anxiety and depression questionnaire HADS,
Rosenberg Self-Esteem Questionnaire
RNLI Reintegration to Normal Life Questionnaire
Social Support Questionnaire SSQ6,
Socio-economic status questionnaire EPICES,
Complementary questionnaire collecting data on socio-professional status.
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [December 2022]
Update of vital status (part 1)
- Generic SF-12 questionnaire [October 2024]
Mesure of the quality of life (part 2)
- Specific QLQ-C30 questionnaire [October 2024]
Mesure of the quality of life (part 2)
Eligibility Criteria
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
Non-inclusion criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Dijon Bourgogne | Dijon | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire Dijon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAYNADIE 2022