An Evaluation of the Psychological Impact of Early Phase... | NCT03818230

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

NCT03818230

Sponsor

University of Manchester

Status

Completed

Last Update Posted

Mar 24, 2020Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Cancer
Depression
Anxiety
Hope
Psychological Distress

Interventions

None (observational study)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2018Actual

Primary Completion Date

Nov 15, 2019Actual

Completion Date

Nov 15, 2019Actual

First Submitted Date

Jan 17, 2019

First Submission Date that Met QC Criteria

Jan 25, 2019

First Posted Date

Jan 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 24, 2020Actual

Name	Class
The Christie NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Name	Type	Description	Arm Group Labels	Other Names
None (observational study)	Other	None (observational study)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.		Approximately 14 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Levels of hope as per the Adult Hope Scale.		Approximately 14 weeks.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Christie NHS Foundation Trust		Manchester	Greater Manchester	M20 4BX	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D003863	Depression
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided