Clinical trial · Interventional
Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating
Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
NCT01606033CI-TRIAL-00105395IPSYcompletedN/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)
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
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 |
|---|---|---|---|
| Metastatic Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaire | Other | — | UNRESOLVED |
| questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- phase II non randomized study
- description
- phase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires : * Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey * understanding of the implications of participating in a clinical trial
- interventionNames
- Other: questionnaires
- Other: questionnaire
- type
- OTHER
- label
- blind randomized phase II or III study
- description
- blind randomized phase II or III study: "control" : 40 patients description of patients feeling by questionnaires : * Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey * understanding of the implications of participating in a clinical trial
- interventionNames
- Other: questionnaires
- Other: questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...) * subject to a 1st, 2nd or 3rd line of antitumor treatment * a phase 2 open labeled study, * a phase 2 or 3 blind randomised study, * a phase 2 or 3 open randomised study, * a standard treatment non participating to a clinical trial * male or female patients ≥ 18 years of age * karnovsky ≥ 70 % or WHO (Performance Status) ≤ 2 * recovered from prior toxicities * social security covered * written informed consent given Exclusion Criteria: * psychiatric disorders, receiving psychotropic treatment * physical or psychological issues * forbidden to be included in this study
References
Publications (0)
Data not yet available
No reference posted for this study.