Patient Perceptions and Willingness to Enroll in Clinical... | NCT03231852

Studies
Patient Perceptions and Willingness to Enroll in Clinical Trials

NCT03231852

Sponsor

University of Virginia

Status

Completed

Last Update Posted

Oct 10, 2018Actual

Enrollment

166Actual

Phase

Not provided

Conditions

Cancer, Clinical Trials

Interventions

Survey

Countries

United States

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

Oct 2018

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

Jun 15, 2017Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

May 1, 2018Actual

First Submitted Date

Jul 24, 2017

First Submission Date that Met QC Criteria

Jul 24, 2017

First Posted Date

Jul 27, 2017Actual

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

Oct 9, 2018

Last Update Posted Date

Oct 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Linda R Duska, Professor, Department of Obstetrics and Gynecology, University of VirginiaPrincipal Investigator

Lead Sponsor

University of VirginiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be approached to complete a survey assessing willingness to participate in clinical trials. The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess willingness to participate.

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

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Population		Women with a gynecologic malignancy will complete several surveys to assess their willingness to participate in clinical trials.	Other: Survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	Attitudes and Randomized Trial Questionnaire (ARTQ), Hospital Anxiety and Depression Scale, Perception Survey	Study Population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Willingness to Participate in Clinical Trials	Bivariate outcome derived from ARTQ survey	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of gynecologic malignancy
English or Spanish literate

Exclusion Criteria:

Prior enrollment in a clinical trial
Currently pregnant
Currently incarcerated

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

All women presenting to the gynecologic oncology clinic meeting the inclusion/exclusion criteria will be approached to participate in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linda Duska, MD, MPH	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22902	United States

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

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided