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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship

Conditions
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Lymphoma

Intervention / Treatment
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* Other: Questionnaires/Scales
* Other: Human blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lymphoma survivorship<br>This present study is based on an interventional (with an analysis of human blood sample) and on the use of different Questionnaires/Scales. | Other: Questionnaires/Scales<br>* Scale of Fear of Cancer Recurrence Inventory, Hospital Anxiety and Depression Scale, Evaluation of stress and life quality.<br>Other: Human blood sample<br>* The intervention is based on blood test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients developing a Fear of Cancer Recurrence according to the scale of Fear of Cancer Recurrence Inventory. | A score greater than or equal to 13 in the under-scale 2 of Fear of Cancer Recurrence Inventory (severity) represents the threshold value and a greater score than 19/32 indicates a very intensive Fear of Cancer Recurrence. | Day 0, Month 12 and Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Patient factors | Patient's age, sex, accommodation, marital status, education level, resources, co-morbidity, personal story/Paykel scale, and biological stress' marker are evaluated. | Day 0 | 
| Analysis of disease factors | Histologic type, disease stade and risk factors (Hasenclever score, Prognostic index for lymphoma (B or T) and Prognostic index for follicular lymphoma) are evaluated. | Day 0 | 
| Analysis of Treatment factors | Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated. | Day 0 | 
| Analysis of psychological disorders | Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation. | Day 0, Month 12 and Month 24 | 
| Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality association | Life's quality is evaluated by 36-Item Short Form Survey. | Day 0, Month 12 and Month 24 | 
| Analysis of trigger factors and coping | Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated. | Day 0, Month 12 and Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Cancer survivorship, Fear