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Psychological Distress Experience (Vraiment)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03905876
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : February 3, 2021
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary:
While there is currently some study on the motivations and experiences of patients integrating early phase clinical trials, to our knowledge, no study has explored the future of patients coming out of these trials. It is therefore urgent to better understand the feelings and experiences of patients who discontinue their treatment in a clinical trial of early phase (EP) to provide them with tailored and personalized support. In addition, the end of treatment may have a different impact on the person depending on whether the treatment was discontinued due to the protocol (the patient received the full treatment as planned) or to an early withdrawal (intolerable toxicities or progression of the disease).

Condition or disease Intervention/treatment Phase
Psychological Distress Cancer Other: Questionnaire Not Applicable

Detailed Description:

EP trials are crucial in the development of a new cancer treatment. Given the side effects and limited knowledge of any new treatment, the inclusion of patients in this EP faces ethical barriers and communication barriers. This is all the more true as EPs are generally aimed at patients with advanced cancer. Also, faced with these different issues, volunteer patients usually have ambivalent motives. Catt and his collaborators have shown that the primary motivations for agreeing to integrate an early phase are the medical benefits, then the best option available, the maintenance of hope and only then, the aid to research.

And more, at the beginning of a EP trial, most patients simultaneously experience multiple complex symptoms related to their cancer or treatment. These symptoms and their functional consequences generate psychological distress and reduce their quality of life related to health. Measuring psychological distress and quality of life before entering a clinical trial is therefore essential for the analysis of psychopathological processes.

Since emotional regulation involves many aspects, it seems scientifically relevant to choose central scales, which cover broad psychopathological functions, to capture the psychological distress of patients. This battery of scales should include an assessment of levels of anxiety, depression and anger (as markers of irritability) but also pre-morbid psychological predispositions. Indeed, some variables such as resilience and optimism are known to influence the level of psychopathological symptomatology and the experience of cancer. Finally, qualitative interviews would better capture the experience of patients with advanced cancer when they are confronted with an end of treatment in EP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychological Experience of the End of the Treatment During a Clincal Trial of the Early Ohase and Role of the Initial prédispositions ( VRAIMENT)
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
assessment of psychological experience
Other: Questionnaire
Questionnaire to evaluate psychological experience

Primary Outcome Measures :
  1. Score of anxiety and depression at the end of treatement in an early clinical phase by using the scale HADS (hospital anxiety and depression scale). The range is 0 to 21. The severe anxiety or depression is 21. [ Time Frame: Approximatey 36 months ]
    Comparison of the questionnaires collected at the time of inclusion and end of treatment in an early clinical phase

Secondary Outcome Measures :
  1. Anxiety score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21. [ Time Frame: Day 1 and approximately 36 months ]
    Baseline and end of treatment

  2. Depression score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21. [ Time Frame: Day 1 and approximately 36 months ]
    Baseline and end of treatment

  3. Anger assessed by using the STAXI-2 questionnaire (stait-trait anger expression inventory) [ Time Frame: Day 1 and approximately 36 months ]
    Baseline and end of treatment

  4. Optimism assessed by using the optimism scale (the Life Orientation Test-Revised - LOT-R) . The range is 0 to 40. [ Time Frame: Day 1 ]

  5. Resilience assessed by using the resilience score (the Connor-Davidson Resilience Scale - CD-RICS-10). The range is 0 to 40. [ Time Frame: Day 1 ]

  6. Overall quality of life score assessed by the EORTC (european organization for research and treatment of cancer) questionnaire QLQ-C30 (quality questionnaire) [ Time Frame: Day 1 and approximately 36 months ]
    Baseline and end of treatment

  7. Reason for discontinuation of trial (i.e., intolerable toxicity, disease progression or termination of the protocol as described in the trial) [ Time Frame: approximately 36 months ]
    End of treament

  8. Language markers through 3 main contents: 1/ the experience of the study exit, 2/ the representations of the clinical trial in which the patient participated and 3/ his future. [ Time Frame: Day 1 and approximately 36 months ]
    Baseline and end of treatment

  9. Motivation assessed by using a motivation questionnaire [ Time Frame: Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven solid cancer locally advanced or metastatic in treatment failure with standard treatments
  • Antitumor therapy in an early phase clinical trial
  • Comprehension in French sufficient for a good completion of the questionnaires
  • Informed consent signed before any specific procedure to study
  • Belong to a French social security scheme or equivalent scheme
  • Age ≥ 18 years

Exclusion Criteria:

  • Score <15 on the Montreal Cognitive Assessment (MoCA) test assessing overall cognitive functioning
  • Presence of proven psychiatric disorders (eg, mental retardation, psychotic disorders, learning disabilities, attention deficit / hyperactivity disorder, bipolar disorder ...), excluding reactional mood disorders to the experience of the disease, or receiving treatment psychotropic disorder that ability of reasoning, judgment or understanding
  • Possibility of benefiting from standard therapeutic options
  • Included in an exclusive clinical trial or for which the sponsor has refused to that his trial are associate to the study "VRAIMENT"
  • Physical inability to answer questionnaires
  • Legal incapacity or limited legal capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03905876

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Contact: Estelle GUERDOUX-NINOT 0467613100 ext +33
Contact: Diego TOSI, Dr 0467613100 ext +33

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Institut régional du Cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: Jean Pierre Bleuse    +33467613100   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
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Study Director: jean Pierre BLEUSE, Dr Insititut régional de Cancer de Montpellier

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle Identifier: NCT03905876    
Other Study ID Numbers: 2018-A02330-55
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
Psychological experience
early clinical trial
initial predisposition