Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship
- Conditions
- Lymphoma
- Interventions
- Other: Questionnaires/ScalesOther: Human blood sample
- Registration Number
- NCT03260855
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- Person under judicial protection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lymphoma survivorship Questionnaires/Scales This present study is based on an interventional (with an analysis of human blood sample) and on the use of different Questionnaires/Scales. Lymphoma survivorship Human blood sample This present study is based on an interventional (with an analysis of human blood sample) and on the use of different Questionnaires/Scales.
- Primary Outcome Measures
Name Time Method Percentage of patients developing a Fear of Cancer Recurrence according to the scale of Fear of Cancer Recurrence Inventory. Day 0, Month 12 and Month 24 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.
- Secondary Outcome Measures
Name Time Method Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality association Day 0, Month 12 and Month 24 Life's quality is evaluated by 36-Item Short Form Survey.
Analysis of "Treatment" factors Day 0 Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated.
Analysis of psychological disorders Day 0, Month 12 and Month 24 Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation.
Analysis of "Patient" factors Day 0 Patient's age, sex, accommodation, marital status, education level, resources, co-morbidity, personal story/Paykel scale, and biological stress' marker are evaluated.
Analysis of "disease" factors Day 0 Histologic type, disease stade and risk factors (Hasenclever score, Prognostic index for lymphoma (B or T) and Prognostic index for follicular lymphoma) are evaluated.
Analysis of trigger factors and coping Day 0, Month 12 and Month 24 Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated.
Trial Locations
- Locations (1)
Institut Universitaire du Cancer de Toulouse CHU de Toulouse
🇫🇷Toulouse, France