Vraiment: Psychological Distress Experience

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Recruiting

CT.gov ID

NCT03905876

Collaborator

(none)

120

Enrollment

Location

Arm

58.3

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 21, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Other: assessment of psychological experience

Questionnaire

Other: Questionnaire

Questionnaire to evaluate psychological experience

Outcome Measures

Primary Outcome Measures

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. [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut régional du Cancer de Montpellier	Montpellier		France	34298

Sponsors and Collaborators

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

Study Director: jean Pierre BLEUSE, Dr, Insititut régional de Cancer de Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Institut du Cancer de Montpellier - Val d'Aurelle

ClinicalTrials.gov Identifier:

NCT03905876

Other Study ID Numbers:

2018-A02330-55

First Posted:

Apr 5, 2019

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle

Psychological experience

early clinical trial

initial predisposition

Study Results

No Results Posted as of Jun 21, 2022