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NCT03818230 Clinical Trial

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

Depression Clinical Trial

— EPIC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03818230
Other study ID # NHS001389
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 21, 2018
Est. completion date November 15, 2019

Study information
Verified date March 2020
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date November 15, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• None (observational study)
None (observational study)

Locations
Country Name City State
United Kingdom The Christie NHS Foundation Trust Manchester Greater Manchester

Sponsors (2)
Lead Sponsor Collaborator
University of Manchester The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire. Approximately 14 weeks.
Secondary Levels of hope as per the Adult Hope Scale. Approximately 14 weeks.
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