Questionnaire Pre-Test Study

NCT ID: NCT03248635

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-25

Study Completion Date

2020-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Focus group

Male and female adults age 40-75

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark P Purdue, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Social & Scientific Systems, INC

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-C-N139

Identifier Type: -

Identifier Source: secondary_id

999917139

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RCT of QPS vs General Information Sheet
NCT03287492 ACTIVE_NOT_RECRUITING NA
Personality and Cancer Care Study
NCT04625439 COMPLETED NA