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

Completed

• Conditions: Anxiety; Cancer; Depression; Hope; Psychological Distress

• Registration Number: NCT03818230
• Lead Sponsor: University of Manchester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-21
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Levels of hope as per the Adult Hope Scale.	Approximately 14 weeks.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom