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

NCT ID: NCT03818230

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-21

Study Completion Date

2019-11-15

Brief Summary

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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

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Conditions

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Cancer Depression Anxiety Hope Psychological Distress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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None (observational study)

None (observational study)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Dr Natalie Cook

Honorary Consultant in Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NHS001389

Identifier Type: -

Identifier Source: org_study_id

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