Living Conditions After Non-Hodgkin's Lymphoma in France

Trial Title: Living Conditions After Non-Hodgkin's Lymphoma in France

NCT ID: NCT05583318

Condition: Non-hodgkin's Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Data collection
Description: Data from hematological malignancy registries
Arm group label: Part 1: Patients diagnosed with non-Hodgkin's lymphoma

Intervention type: Other
Intervention name: Questionnaires
Description: 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.
Arm group label: Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update

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.

Criteria for eligibility:

Study pop:
Patients with non-Hodgkin's lymphoma

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Chu Dijon Bourgogne

Address:
City: Dijon
Country: France

Status: Recruiting

Contact:
Last name: Marc MAYNADIE

Phone: 03 80 39 30 48
Email: Marc.Maynadie@u-bourgogne.fr

Start date: September 1, 2023

Completion date: September 2025

Lead sponsor:
Agency: Centre Hospitalier Universitaire Dijon
Agency class: Other

Source: Centre Hospitalier Universitaire Dijon

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05583318