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

NCT03260855 | Completed

• 2 other identifiers: RC31/16/88232017-A01208-45
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

Lymphoma; Cancer survivorship; Fear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Analysis of "Patient" factors

  Day 0

• Analysis of "disease" factors

  Day 0

• Analysis of "Treatment" factors

  Day 0

• Analysis of psychological disorders

  Day 0, Month 12 and Month 24

• Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality association

  Day 0, Month 12 and Month 24

Study Arms (1)

Lymphoma survivorship

OTHER

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; Other: Human blood sample

Interventions

Questionnaires/Scales OTHER

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

Lymphoma survivorship

Human blood sample OTHER

The intervention is based on blood test.

Lymphoma survivorship

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Person under judicial protection

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Institut Universitaire du Cancer de Toulouse CHU de Toulouse

Toulouse, 31000, France

Location

Related Publications (10)

• 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.

  PMID: 25646470 BACKGROUND

• 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.

  PMID: 22553155 BACKGROUND

• 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.

  PMID: 26498342 BACKGROUND

• 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.

  PMID: 24293081 BACKGROUND

• 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.

  PMID: 26030308 BACKGROUND

• 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.

  PMID: 23384721 BACKGROUND

• 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.

  PMID: 20617394 BACKGROUND

• 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.

  PMID: 23475398 BACKGROUND

• 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.

  PMID: 18414902 BACKGROUND

• 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.

  PMID: 26036473 BACKGROUND

MeSH Terms

Conditions

Lymphoma

Interventions

Surveys and Questionnaires; Weights and Measures

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guy Laurent, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 24, 2017
• Study Start: November 28, 2017
• Primary Completion: February 2, 2021
• Study Completion: March 2, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)