<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260855</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/16/8823</org_study_id>
    <secondary_id>2017-A01208-45</secondary_id>
    <nct_id>NCT03260855</nct_id>
  </id_info>
  <brief_title>Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship</brief_title>
  <acronym>PResEnCE</acronym>
  <official_title>Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation de l'Avenir</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer survivorship has become an important aspect of oncology research due to the risk of&#xD;
      physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim&#xD;
      of this research is to measure frequency and intensity of one of these issues: the fear of&#xD;
      cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Indeed, in a recent work published by our team, several complication types in cancer&#xD;
      survivorship has been identified: physical but also psychosocial disorders, which can lead to&#xD;
      quality of life deterioration. The FCR in lymphoma pathology isn't yet documented and only a&#xD;
      few studies concern the risk factors determination (age, sex, disease stage, treatment type,&#xD;
      level of education, co-morbidity, isolation (familial status), financial resources, character&#xD;
      trait in others cancers. Moreover, the FCR can be amplified by familial (young children) or&#xD;
      professional responsibilities (self-employed profession). The consequences of FCR are poorly&#xD;
      evaluated and are, however, potentially manifold: psychologic disorders, psychotropic&#xD;
      consummation, delay of return to work and quality of life deterioration.&#xD;
&#xD;
      So, FCR is an innovating research project, which studies the FCR incidence in the beginning&#xD;
      of lymphoma After-Cancer (AC) M0 and also the associated risk factors we can class in three&#xD;
      types: 1. &quot;Patient&quot; factors (age, sex, habitat: rural/urban, familial status, level of&#xD;
      education, financial resources, co-morbidity), 2. &quot;disease&quot; factors: histological type,&#xD;
      disease stage, risk factor, 3. &quot;treatment&quot; factors : conventional versus intensified.&#xD;
      Moreover, we will study the consequences of FCR M0 upon quality of life and if there is a&#xD;
      need of psychotherapy from the very beginning of after-cancer phase, for high intensity FCR.&#xD;
&#xD;
      This present study is based on an interventional (with an analysis of human blood sample)&#xD;
      prospective cohort, treated with anthracycline-containing regimens. This is a monocentric&#xD;
      study which takes place in the Institut University du Cancer of Toulouse. The evaluation uses&#xD;
      the scale of Fear of Cancer Recurrence Inventory (FCRI). The inclusion period lasts 2 years&#xD;
      and patients will be followed during 2 years with a measure at M0, M12 and M24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Actual">March 2, 2023</completion_date>
  <primary_completion_date type="Actual">February 2, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients developing a Fear of Cancer Recurrence according to the scale of Fear of Cancer Recurrence Inventory.</measure>
    <time_frame>Day 0, Month 12 and Month 24</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of &quot;Patient&quot; factors</measure>
    <time_frame>Day 0</time_frame>
    <description>Patient's age, sex, accommodation, marital status, education level, resources, co-morbidity, personal story/Paykel scale, and biological stress' marker are evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of &quot;disease&quot; factors</measure>
    <time_frame>Day 0</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of &quot;Treatment&quot; factors</measure>
    <time_frame>Day 0</time_frame>
    <description>Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of psychological disorders</measure>
    <time_frame>Day 0, Month 12 and Month 24</time_frame>
    <description>Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality association</measure>
    <time_frame>Day 0, Month 12 and Month 24</time_frame>
    <description>Life's quality is evaluated by 36-Item Short Form Survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of trigger factors and coping</measure>
    <time_frame>Day 0, Month 12 and Month 24</time_frame>
    <description>Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Lymphoma survivorship</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This present study is based on an interventional (with an analysis of human blood sample) and on the use of different Questionnaires/Scales.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires/Scales</intervention_name>
    <description>Scale of Fear of Cancer Recurrence Inventory, Hospital Anxiety and Depression Scale, Evaluation of stress and life quality.</description>
    <arm_group_label>Lymphoma survivorship</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human blood sample</intervention_name>
    <description>The intervention is based on blood test.</description>
    <arm_group_label>Lymphoma survivorship</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complete response of lymphoma (Cheson criteria 2007) after initial treatment&#xD;
&#xD;
          -  Malin lymphoma (Hodgkin or not) treated with anthracyclines for at least 6 cycles :&#xD;
             Adriamycin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) or BEACOPP,&#xD;
             Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (CHOP) et Rituximab&#xD;
             (R-CHOP), miniCHOP et RminiCHOP, RACVBP having received or not an intensification with&#xD;
             autologous hematopoietic stem cell transplantation in first-line&#xD;
&#xD;
          -  Registered the consent to be included in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person under judicial protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guy Laurent, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Universitaire du Cancer de Toulouse CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <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>
    <PMID>25646470</PMID>
  </reference>
  <reference>
    <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>
    <PMID>22553155</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26498342</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24293081</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26030308</PMID>
  </reference>
  <reference>
    <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>
    <PMID>23384721</PMID>
  </reference>
  <reference>
    <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>
    <PMID>20617394</PMID>
  </reference>
  <reference>
    <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>
    <PMID>23475398</PMID>
  </reference>
  <reference>
    <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>
    <PMID>18414902</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26036473</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lymphoma</keyword>
  <keyword>Cancer survivorship</keyword>
  <keyword>Fear</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260855
org study id: RC31/16/8823
secondary id: 2017-A01208-45
nct id: NCT03260855
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of patients developing a Fear of Cancer Recurrence according to the scale of Fear of Cancer Recurrence Inventory.
time frame: Day 0, Month 12 and Month 24
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.
measure: Analysis of "Patient" factors
time frame: Day 0
description: Patient's age, sex, accommodation, marital status, education level, resources, co-morbidity, personal story/Paykel scale, and biological stress' marker are evaluated.
measure: Analysis of "disease" factors
time frame: Day 0
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.
measure: Analysis of "Treatment" factors
time frame: Day 0
description: Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated.
measure: Analysis of psychological disorders
time frame: Day 0, Month 12 and Month 24
description: Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation.
measure: Analysis of scale of Fear of Cancer Recurrence Inventory and life's quality association
time frame: Day 0, Month 12 and Month 24
description: Life's quality is evaluated by 36-Item Short Form Survey.
measure: Analysis of trigger factors and coping
time frame: Day 0, Month 12 and Month 24
description: Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated.
arm group label: Lymphoma survivorship
arm group type: Other
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: Questionnaires/Scales
description: Scale of Fear of Cancer Recurrence Inventory, Hospital Anxiety and Depression Scale, Evaluation of stress and life quality.
arm group label: Lymphoma survivorship
intervention type: Other
intervention name: Human blood sample
description: The intervention is based on blood test.
arm group label: Lymphoma survivorship
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guy Laurent, Pr
role: Principal Investigator
affiliation: CHU Toulouse
facility: 
country: France
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.
PMID: 25646470
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.
PMID: 22553155
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.
PMID: 26498342
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.
PMID: 24293081
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.
PMID: 26030308
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.
PMID: 23384721
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.
PMID: 20617394
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.
PMID: 23475398
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.
PMID: 18414902
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.
PMID: 26036473
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Recurrence
sharing ipd: No