Psychological Experience of Discontinuation an Early Phase Treatment by Patients (VRAIMENT)

October 2, 2023 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34298
        • Institut Régional du Cancer de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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.
Time Frame: Approximatey 36 months
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.
Time Frame: Day 1 and approximately 36 months
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.
Time Frame: Day 1 and approximately 36 months
Baseline and end of treatment
Day 1 and approximately 36 months
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
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.
Time Frame: Day 1
Baseline
Day 1
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
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)
Time Frame: Day 1 and approximately 36 months
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)
Time Frame: approximately 36 months
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.
Time Frame: Day 1 and approximately 36 months
Baseline and end of treatment
Day 1 and approximately 36 months
Motivation assessed by using a motivation questionnaire
Time Frame: Day 1
Baseline
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-A02330-55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe