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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03260855
Acronym
PResEnCE
Enrollment
200
Registered
2017-08-24
Start date
2017-11-28
Completion date
2023-03-02
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Lymphoma, Cancer survivorship, Fear

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.

Interventions

OTHERQuestionnaires/Scales

Scale of Fear of Cancer Recurrence Inventory, Hospital Anxiety and Depression Scale, Evaluation of stress and life quality.

OTHERHuman blood sample

The intervention is based on blood test.

Sponsors

Fondation de l'Avenir
CollaboratorOTHER
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 24A 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

MeasureTime frameDescription
Analysis of disease factorsDay 0Histologic 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 Treatment factorsDay 0Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated.
Analysis of Patient factorsDay 0Patient's age, sex, accommodation, marital status, education level, resources, co-morbidity, personal story/Paykel scale, and biological stress' marker are evaluated.
Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality associationDay 0, Month 12 and Month 24Life's quality is evaluated by 36-Item Short Form Survey.
Analysis of trigger factors and copingDay 0, Month 12 and Month 24Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated.
Analysis of psychological disordersDay 0, Month 12 and Month 24Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026