Clinical trial · Observational
An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.
NCT03818230CI-TRIAL-00044197EPICcompletedClinicalTrials.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 is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| Hope | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| None (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.
- timeFrame
- Approximately 14 weeks.
Secondary outcomes (1)
- measure
- Levels of hope as per the Adult Hope Scale.
- timeFrame
- Approximately 14 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years and older * Able to provide informed consent * Are being considered for an early phase clinical trial Exclusion Criteria: * Patients unable to comprehend English language
References
Publications (0)
Data not yet available
No reference posted for this study.