Psychological Experience of Discontinuation an Early Phase Treatment by Patients

NCT ID: NCT03905876

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2024-04-04

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.

Conditions

Psychological Distress; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

assessment of psychological experience

Questionnaire

Group Type: OTHER

Questionnaire

Intervention Type: OTHER

Questionnaire to evaluate psychological experience

Interventions

Questionnaire

Questionnaire to evaluate psychological experience

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean Pierre BLEUSE, Dr

Role: STUDY_DIRECTOR

Insititut régional de Cancer de Montpellier

Locations

Institut régional du Cancer de Montpellier

Montpellier, , France

Countries

France

References

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Other Identifiers

2018-A02330-55

Identifier Type: -

Identifier Source: org_study_id