NCT03818230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

January 17, 2019

Last Update Submit

March 23, 2020

Conditions

CancerDepressionAnxietyHopePsychological Distress

Keywords

Clinical trialsEarly phase clinical trialsExperimental cancer medicine

Outcome Measures

Primary Outcomes (1)

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

    Approximately 14 weeks.

Secondary Outcomes (1)

  • Levels of hope as per the Adult Hope Scale.

    Approximately 14 weeks.

Interventions

None (observational study)OTHER

None (observational study)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Aged 18 years and older
  • Able to provide informed consent
  • Are being considered for an early phase clinical trial

You may not qualify if:

  • Patients unable to comprehend English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

NeoplasmsDepressionAnxiety Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Consultant in Medical Oncology

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 28, 2019

Study Start

August 21, 2018

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)