Clinical trial NCT03905876: Psychological Experience of Discontinuation an Early Phase Treatment by Patients
Official title: Psychological Experience of the End of the Treatment During a Clincal Trial of the Early Phase and Role of the Initial prédispositions ( VRAIMENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Cancer
Keywords: Psychological experience
early clinical trial
initial predisposition
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Approximatey 36 months
Secondary outcomes:
measure: Anxiety score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.
timeFrame: Day 1 and approximately 36 months
measure: Depression score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.
timeFrame: Day 1 and approximately 36 months
measure: Anger assessed by using the STAXI-2 questionnaire (stait-trait anger expression inventory)
timeFrame: Day 1 and approximately 36 months
measure: Optimism assessed by using the optimism scale (the Life Orientation Test-Revised - LOT-R) . The range is 0 to 40.
timeFrame: Day 1
measure: Resilience assessed by using the resilience score (the Connor-Davidson Resilience Scale - CD-RICS-10). The range is 0 to 40.
timeFrame: Day 1
measure: Overall quality of life score assessed by the EORTC (european organization for research and treatment of cancer) questionnaire QLQ-C30 (quality questionnaire)
timeFrame: Day 1 and approximately 36 months
measure: Reason for discontinuation of trial (i.e., intolerable toxicity, disease progression or termination of the protocol as described in the trial)
timeFrame: approximately 36 months
measure: 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.
timeFrame: Day 1 and approximately 36 months
measure: Motivation assessed by using a motivation questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
Study officials:
affiliation: Insititut régional de Cancer de Montpellier
name: jean Pierre BLEUSE, Dr
role: STUDY_DIRECTOR
References:
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