Psychological Experience of Discontinuation an Early Phase Treatment by Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Psychological Experience of the End of the Treatment During a Clincal Trial of the Early Phase and Role of the Initial prédispositions ( VRAIMENT)

Conditions
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Cancer, Psychological Distress

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: assessment of psychological experience<br>Questionnaire | Other: Questionnaire<br>* Questionnaire to evaluate psychological experience<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Comparison of the questionnaires collected at the time of inclusion and end of treatment in an early clinical phase | Approximatey 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21. | Baseline and end of treatment | Day 1 and approximately 36 months | 
| Depression score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21. | Baseline and end of treatment | Day 1 and approximately 36 months | 
| Anger assessed by using the STAXI-2 questionnaire (stait-trait anger expression inventory) | Baseline and end of treatment | Day 1 and approximately 36 months | 
| Optimism assessed by using the optimism scale (the Life Orientation Test-Revised - LOT-R) . The range is 0 to 40. | Baseline | Day 1 | 
| Resilience assessed by using the resilience score (the Connor-Davidson Resilience Scale - CD-RICS-10). The range is 0 to 40. | Baseline | Day 1 | 
| Overall quality of life score assessed by the EORTC (european organization for research and treatment of cancer) questionnaire QLQ-C30 (quality questionnaire) | Baseline and end of treatment | Day 1 and approximately 36 months | 
| Reason for discontinuation of trial (i.e., intolerable toxicity, disease progression or termination of the protocol as described in the trial) | End of treament | approximately 36 months | 
| 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. | Baseline and end of treatment | Day 1 and approximately 36 months | 
| Motivation assessed by using a motivation questionnaire | Baseline | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychological experience, early clinical trial, initial predisposition