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Questionnaire Pre-Test Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248635
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Cancer

Detailed Description:
The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to conduct broadbased, high quality, high impact research to uncover the causes of cancer and the means of its prevention. To this end, DCEG relies on epidemiologic data captured on self-reported questionnaires. The purpose of this pre-test study is to pilot a questionnaire to: (1) detect problems that might contribute to response errors; (2) develop ideas for improving the questionnaire in order to minimize such errors; and (3) assess the length of time to complete the questionnaire. If there are specific sections of the questionnaire that are skipped by all 30 initial participants, then six (6) additional, separate individuals may be invited to pre-test the questionnaire for sections that were missed by the initial set of participants. After a post-revision of the questionnaire based on the pre-test results, up to 10 additional, separate individuals will be invited to test the revised questionnaire for duration and comprehensibility.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Online Questionnaire Pre-Test Study
Actual Study Start Date : May 25, 2018
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : April 2, 2020

Group/Cohort
Focus group
Male and female adults age 40-75



Primary Outcome Measures :
  1. Understanding of the Questionnaire [ Time Frame: Time of Interview ]
    Response errors and comments on interpretation of questions and response categories, and the duration needed to complete the questionnaire modules.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample of adult volunteers in geographic proximity to contractor in Durham, NC
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248635


Locations
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United States, North Carolina
Social & Scientific Systems, INC
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark P Purdue, M.D. National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03248635    
Other Study ID Numbers: 999917139
17-C-N139
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Survey
Pre-Test