Psychological Experience of Discontinuation an Early Phase Treatment by Patients

Cancer Clinical Trial

— VRAIMENT  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03905876
• Other study ID #: 2018-A02330-55
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Psychological Distress

Intervention

Other:
• Questionnaire
Questionnaire to evaluate psychological experience

Locations

Country	Name	City	State
France	Institut régional du Cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (8)

Balbuena L, Bowen R, Baetz M, Marwaha S. Mood Instability and Irritability as Core Symptoms of Major Depression: An Exploration Using Rasch Analysis. Front Psychiatry. 2016 Oct 26;7:174. doi: 10.3389/fpsyt.2016.00174. eCollection 2016. — View Citation

Bozo O, Gundogdu E, Buyukasik-Colak C. The moderating role of different sources of perceived social support on the dispositional optimism-- posttraumatic growth relationship in postoperative breast cancer patients. J Health Psychol. 2009 Oct;14(7):1009-20. doi: 10.1177/1359105309342295. — View Citation

Bredart A, Bodson S, Le Tourneau C, Flahault C, Bonnetain F, Beaudeau A, Coquan E, Dolbeault S, Paoletti X. Patients' perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12596. Epub 2016 Oct 12. — View Citation

Catt S, Langridge C, Fallowfield L, Talbot DC, Jenkins V. Reasons given by patients for participating, or not, in Phase 1 cancer trials. Eur J Cancer. 2011 Jul;47(10):1490-7. doi: 10.1016/j.ejca.2011.02.020. Epub 2011 Mar 30. — View Citation

Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ. What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011 Jan 1;29(1):61-8. doi: 10.1200/JCO.2010.30.0814. Epub 2010 Nov 22. — View Citation

Kroenke K, Johns SA, Theobald D, Wu J, Tu W. Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability. Support Care Cancer. 2013 Mar;21(3):765-73. doi: 10.1007/s00520-012-1578-5. Epub 2012 Sep 1. — View Citation

Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016. — View Citation

Tian J, Hong JS. Assessment of the relationship between resilience and quality of life in patients with digestive cancer. World J Gastroenterol. 2014 Dec 28;20(48):18439-44. doi: 10.3748/wjg.v20.i48.18439. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Anger assessed by using the STAXI-2 questionnaire (stait-trait anger expression inventory)	Baseline and end of treatment	Day 1 and approximately 36 months
Secondary	Optimism assessed by using the optimism scale (the Life Orientation Test-Revised - LOT-R) . The range is 0 to 40.	Baseline	Day 1
Secondary	Resilience assessed by using the resilience score (the Connor-Davidson Resilience Scale - CD-RICS-10). The range is 0 to 40.	Baseline	Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	Motivation assessed by using a motivation questionnaire	Baseline	Day 1