An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03818230

Acronym

EPIC

Enrollment

Registered

2019-01-28

Start date

2018-08-21

Completion date

2019-11-15

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cancer, Depression, Hope, Psychological Distress

Keywords

Clinical trials, Early phase clinical trials, Experimental cancer medicine

Brief summary

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.

Interventions

OTHERNone (observational study)

None (observational study)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.	Approximately 14 weeks.

Secondary

Measure	Time frame
Levels of hope as per the Adult Hope Scale.	Approximately 14 weeks.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026