NCT03248635

Brief Summary

Background: The Division of Cancer Epidemiology and Genetics does research into the causes of cancer and ways to prevent it. It uses data from questionnaires. Sometimes, pre-testing a questionnaire with a group of volunteers can help researchers find errors in it and learn ways to improve it. Objectives: To test a questionnaire for problems that might cause response errors and to develop ideas for improving it. To test how long it takes people to complete it. Eligibility: Adults ages 35-75. Volunteers both with and without a history of tobacco use and with or without a family history of cancer are needed. Design: Participants will be screened with a phone call. Participants will be told what background data to bring to the 1 study visit. An interviewer will give the participants the questionnaire. It will be done with pen and paper. It will take about 1 hour. There will be multiple-choice and open-ended questions. They will be about lifestyle, medical, and environmental factors. Some of the questions will be about possibly illegal or highly sensitive behaviors. Participants will note any questions that they find hard to answer for any reason. They will be asked to answer the best they can, but they can skip any question that they prefer not to answer. The personal data of participants will be deleted when the study is done. The interviewer will observe participants while they do the questionnaire. He or she will look for things like long pauses and confusion. Participants will discuss the exam with the interviewer after they finish. This will take about 1 hour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

August 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

May 25, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

August 11, 2017

Last Update Submit

April 6, 2020

Conditions

Keywords

SurveyPre-Test

Outcome Measures

Primary Outcomes (1)

  • Understanding of the Questionnaire

    Response errors and comments on interpretation of questions and response categories, and the duration needed to complete the questionnaire modules.

    Time of Interview

Study Arms (1)

Focus group

Male and female adults age 40-75

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Convenience sample of adult volunteers in geographic proximity to contractor in Durham, NC

* ELIGIBILITY CRITERIA: * Age 35 to 75 * Men or women * Fluent in English * Able to come to the SSS Durham, NC offices for the in-person interview * Able to provide informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Social & Scientific Systems, INC

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Mark P Purdue, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 14, 2017

Study Start

May 25, 2018

Primary Completion

June 25, 2018

Study Completion

April 2, 2020

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations