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LymphomaPResEnCENCT03260855

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

A study testing Questionnaires/Scales and Human blood sample in people with Lymphoma, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma
What is being tested?
Questionnaires/Scales and Human blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteFrance
Study dates
28 Nov 2017to 2 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Person under judicial protection

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Universitaire du Cancer de Toulouse CHU de Toulouse

    Toulouse, 31000

Other trials in France

About this study

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.

Read the 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.

Conditions
Lymphoma
Being tested
Questionnaires/Scales, Human blood sample
Keywords
Lymphoma, Cancer survivorship, Fear
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaires/ScalesOther

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

  • Human blood sampleOther

    The intervention is based on blood test.

Study groups in NCT03260855
Study groupRoleWhat they receive
Lymphoma survivorshipOtherThis present study is based on an interventional (with an analysis of human blood sample) and on the use of different Questionnaires/Scales.
Receives: Other: Questionnaires/Scales; Other: Human blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0, Month 12 and Month 24

Secondary outcomes (6)

  1. 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.

    Measured: Day 0

  2. 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.

    Measured: Day 0

  3. Analysis of "Treatment" factors

    Conventional treatment versus intensify treatment and adverse effects (grade CTCAE ≥3) are evaluated.

    Measured: Day 0

  4. Analysis of psychological disorders

    Anxiety and depression measured by Hospital Anxiety and Depression Scale and stress' evaluation.

    Measured: Day 0, Month 12 and Month 24

  5. 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.

    Measured: Day 0, Month 12 and Month 24

  6. Analysis of trigger factors and coping

    Score of category 1 and 4 of Fear of Cancer Recurrence Inventory are evaluated.

    Measured: Day 0, Month 12 and Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start28 Nov 2017
  3. Primary completion2 Feb 2021
  4. Study completion2 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03260855
Sponsor's protocol ID
RC31/16/8823
Other IDs
2017-A01208-45
Acronym
PResEnCE
Status last verified
Aug 2023
First submitted
21 Aug 2017
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25646470

  • 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.

    PubMed 22553155

  • 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.

    PubMed 26498342

  • 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.

    PubMed 24293081

  • 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.

    PubMed 26030308

  • 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.

    PubMed 23384721

  • 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.

    PubMed 20617394

  • 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.

    PubMed 23475398

  • 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.

    PubMed 18414902

  • 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.

    PubMed 26036473

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaires/Scales and Human blood sample in people with Lymphoma, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03260855, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.

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