- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03818230
An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients. (EPIC)
March 23, 2020 updated by: Dr Natalie Cook, University of Manchester
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have been referred to the Experimental Cancer Medicine Team (ECMT) at The Christie NHS Foundation Trust, to be considered for participation in an early phase clinical trial.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.
Time Frame: Approximately 14 weeks.
|
Approximately 14 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Levels of hope as per the Adult Hope Scale.
Time Frame: Approximately 14 weeks.
|
Approximately 14 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2018
Primary Completion (Actual)
November 15, 2019
Study Completion (Actual)
November 15, 2019
Study Registration Dates
First Submitted
January 17, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHS001389
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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