Clinical trial · Interventional
Psychological Experience of Discontinuation an Early Phase Treatment by Patients
Psychological Experience of the End of the Treatment During a Clincal Trial of the Early Phase and Role of the Initial prédispositions ( VRAIMENT)
NCT03905876CI-TRIAL-00085980VRAIMENTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- assessment of psychological experience
- description
- Questionnaire
- interventionNames
- Other: Questionnaire
Primary outcomes (1)
- 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
- description
- Comparison of the questionnaires collected at the time of inclusion and end of treatment in an early clinical phase
Secondary outcomes (9)
- measure
- Anxiety score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
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- BACKGROUNDBredart 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. PMID 27734561
- BACKGROUNDKroenke 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. PMID 22941116
- BACKGROUNDCatt 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. PMID 21454072
- BACKGROUNDBalbuena 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. PMID 27833568
- BACKGROUNDTian 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. PMID 25561814
- BACKGROUNDMatzka 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.