Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship (PResEnCE)

Toulouse University Hospital

Status: Completed

Conditions: Lymphoma

Treatments: Other: Questionnaires/Scales; Other: Human blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03260855

2017-A01208-45 (Other Identifier)

RC31/16/8823

Details and patient eligibility

About

Cancer survivorship has become an important aspect of oncology research due to the risk of physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim of this research is to measure frequency and intensity of one of these issues: the fear of cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0.

Full description

Indeed, in a recent work published by our team, several complication types in cancer survivorship has been identified: physical but also psychosocial disorders, which can lead to quality of life deterioration. The FCR in lymphoma pathology isn't yet documented and only a few studies concern the risk factors determination (age, sex, disease stage, treatment type, level of education, co-morbidity, isolation (familial status), financial resources, character trait in others cancers. Moreover, the FCR can be amplified by familial (young children) or professional responsibilities (self-employed profession). The consequences of FCR are poorly evaluated and are, however, potentially manifold: psychologic disorders, psychotropic consummation, delay of return to work and quality of life deterioration.

So, FCR is an innovating research project, which studies the FCR incidence in the beginning of lymphoma After-Cancer (AC) M0 and also the associated risk factors we can class in three types: 1. "Patient" factors (age, sex, habitat: rural/urban, familial status, level of education, financial resources, co-morbidity), 2. "disease" factors: histological type, disease stage, risk factor, 3. "treatment" factors : conventional versus intensified. Moreover, we will study the consequences of FCR M0 upon quality of life and if there is a need of psychotherapy from the very beginning of after-cancer phase, for high intensity FCR.

This present study is based on an interventional (with an analysis of human blood sample) prospective cohort, treated with anthracycline-containing regimens. This is a monocentric study which takes place in the Institut University du Cancer of Toulouse. The evaluation uses the scale of Fear of Cancer Recurrence Inventory (FCRI). The inclusion period lasts 2 years and patients will be followed during 2 years with a measure at M0, M12 and M24.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Complete response of lymphoma (Cheson criteria 2007) after initial treatment
• Malin lymphoma (Hodgkin or not) treated with anthracyclines for at least 6 cycles : Adriamycin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) or BEACOPP, Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (CHOP) et Rituximab (R-CHOP), miniCHOP et RminiCHOP, RACVBP having received or not an intensification with autologous hematopoietic stem cell transplantation in first-line
• Registered the consent to be included in this study

Exclusion criteria

• Person under judicial protection

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Lymphoma survivorship

Other group

Description:

This present study is based on an interventional (with an analysis of human blood sample) and on the use of different Questionnaires/Scales.

Treatment:

Other: Questionnaires/Scales

Other: Human blood sample