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

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires/Scales
Human blood sample
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphoma focused on measuring Lymphoma, Cancer survivorship, Fear

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut Universitaire du Cancer de Toulouse CHU de Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lymphoma survivorship

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Analysis of "Treatment" factors
Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated.
Analysis of psychological disorders
Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation.
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.
Analysis of trigger factors and coping
Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated.

Full Information

First Posted
August 21, 2017
Last Updated
August 22, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT03260855
Brief Title
Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship
Acronym
PResEnCE
Official Title
Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Fondation de l'Avenir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma, Cancer survivorship, Fear

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lymphoma survivorship
Arm Type
Other
Arm Description
This present study is based on an interventional (with an analysis of human blood sample) and on the use of different Questionnaires/Scales.
Intervention Type
Other
Intervention Name(s)
Questionnaires/Scales
Intervention Description
Scale of Fear of Cancer Recurrence Inventory, Hospital Anxiety and Depression Scale, Evaluation of stress and life quality.
Intervention Type
Other
Intervention Name(s)
Human blood sample
Intervention Description
The intervention is based on blood test.
Primary Outcome Measure Information:
Title
Percentage of patients developing a Fear of Cancer Recurrence according to the scale of Fear of Cancer Recurrence Inventory.
Description
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.
Time Frame
Day 0, Month 12 and Month 24
Secondary Outcome Measure Information:
Title
Analysis of "Patient" factors
Description
Patient's age, sex, accommodation, marital status, education level, resources, co-morbidity, personal story/Paykel scale, and biological stress' marker are evaluated.
Time Frame
Day 0
Title
Analysis of "disease" factors
Description
Histologic type, disease stade and risk factors (Hasenclever score, Prognostic index for lymphoma (B or T) and Prognostic index for follicular lymphoma) are evaluated.
Time Frame
Day 0
Title
Analysis of "Treatment" factors
Description
Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated.
Time Frame
Day 0
Title
Analysis of psychological disorders
Description
Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation.
Time Frame
Day 0, Month 12 and Month 24
Title
Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality association
Description
Life's quality is evaluated by 36-Item Short Form Survey.
Time Frame
Day 0, Month 12 and Month 24
Title
Analysis of trigger factors and coping
Description
Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated.
Time Frame
Day 0, Month 12 and Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Laurent, Pr
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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25646470
Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship

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