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

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.

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Key information

Conditions

Cancer Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Hope Mental Disorders Neoplasms Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None (Observational study)

Other

None (observational study)

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.

Time frame: Approximately 14 weeks.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

The Christie NHS Foundation Trust

Registry information

Acronym: EPIC

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jan 28, 2019
Registry last updated: Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed