Clinical trial NCT03260855: Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship
Official title: Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Keywords: Lymphoma
Cancer survivorship
Fear
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2017-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage of patients developing a Fear of Cancer Recurrence according to the scale of Fear of Cancer Recurrence Inventory.
timeFrame: Day 0, Month 12 and Month 24
Secondary outcomes:
measure: Analysis of "Patient" factors
timeFrame: Day 0
measure: Analysis of "disease" factors
timeFrame: Day 0
measure: Analysis of "Treatment" factors
timeFrame: Day 0
measure: Analysis of psychological disorders
timeFrame: Day 0, Month 12 and Month 24
measure: Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality association
timeFrame: Day 0, Month 12 and Month 24
measure: Analysis of trigger factors and coping
timeFrame: Day 0, Month 12 and Month 24
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse CHU de Toulouse
Study officials:
affiliation: CHU Toulouse
name: Guy Laurent, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barboza Solis C, Kelly-Irving M, Fantin R, Darnaudery M, Torrisani J, Lang T, Delpierre C. Adverse childhood experiences and physiological wear-and-tear in midlife: Findings from the 1958 British birth cohort. Proc Natl Acad Sci U S A. 2015 Feb 17;112(7):E738-46. doi: 10.1073/pnas.1417325112. Epub 2015 Feb 2.
citation: Bertuccio P, Bosetti C, Malvezzi M, Levi F, Chatenoud L, Negri E, La Vecchia C. Trends in mortality from leukemia in Europe: an update to 2009 and a projection to 2012. Int J Cancer. 2013 Jan 15;132(2):427-36. doi: 10.1002/ijc.27624. Epub 2012 May 29.
citation: Compaci G, Rueter M, Lamy S, Oberic L, Recher C, Lapeyre-Mestre M, Laurent G, Despas F. Ambulatory Medical Assistance--After Cancer (AMA-AC): A model for an early trajectory survivorship survey of lymphoma patients treated with anthracycline-based chemotherapy. BMC Cancer. 2015 Oct 24;15:781. doi: 10.1186/s12885-015-1815-7.
citation: Koch L, Bertram H, Eberle A, Holleczek B, Schmid-Hopfner S, Waldmann A, Zeissig SR, Brenner H, Arndt V. Fear of recurrence in long-term breast cancer survivors-still an issue. Results on prevalence, determinants, and the association with quality of life and depression from the cancer survivorship--a multi-regional population-based study. Psychooncology. 2014 May;23(5):547-54. doi: 10.1002/pon.3452. Epub 2013 Nov 30.
citation: McGinty HL, Small BJ, Laronga C, Jacobsen PB. Predictors and patterns of fear of cancer recurrence in breast cancer survivors. Health Psychol. 2016 Jan;35(1):1-9. doi: 10.1037/hea0000238. Epub 2015 Jun 1.
citation: Mehnert A, Koch U, Sundermann C, Dinkel A. Predictors of fear of recurrence in patients one year after cancer rehabilitation: a prospective study. Acta Oncol. 2013 Aug;52(6):1102-9. doi: 10.3109/0284186X.2013.765063. Epub 2013 Feb 5.
citation: Simard S, Savard J, Ivers H. Fear of cancer recurrence: specific profiles and nature of intrusive thoughts. J Cancer Surviv. 2010 Dec;4(4):361-71. doi: 10.1007/s11764-010-0136-8. Epub 2010 Jul 10.
citation: Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.
citation: Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15.
citation: Spector DJ, Noonan D, Mayer DK, Benecha H, Zimmerman S, Smith SK. Are lifestyle behavioral factors associated with health-related quality of life in long-term survivors of non-Hodgkin lymphoma? Cancer. 2015 Sep 15;121(18):3343-51. doi: 10.1002/cncr.29490. Epub 2015 Jun 2.