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Clinical Trials/NCT03818230
NCT03818230
Completed
N/A

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

University of Manchester1 site in 1 country64 target enrollmentAugust 21, 2018
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ConditionsCancerDepressionAnxietyHopePsychological Distress

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Manchester
Enrollment
64
Locations
1
Primary Endpoint
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 21, 2018
End Date
November 15, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Natalie Cook

Honorary Consultant in Medical Oncology

University of Manchester

Eligibility Criteria

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

Outcomes

Primary Outcomes

Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.

Time Frame: Approximately 14 weeks.

Secondary Outcomes

  • Levels of hope as per the Adult Hope Scale.(Approximately 14 weeks.)

Study Sites (1)

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