Evaluating Shared Decision-Making for Lung Cancer Screening Among Chinese Populations in the United States

March 13, 2024 updated by: M.D. Anderson Cancer Center

Understanding Shared Decision-Making for Lung Cancer Screening Among Chinese Populations in the U.S.

This study better understands the views on shared decision-making among Chinese adults who smoke or who have a spouse who smokes. Lung cancer is the second most common cancer among men and women in the United States and is the number one cause of cancer-related mortality among Asians and Pacific Islanders. Clinicians are recommended to initiate conversations about lung cancer screening with eligible patients, provide information about the benefits and harms, and engage in shared decision-making. However, a patient's cultural background can influence decision-making in many ways. Given this, there is a need to understand the perceptions of shared decision-making among different populations (in this case, Asian populations) in order to inform the design of culturally sensitive decision aids for cancer screening. This study evaluates how Chinese populations in the U.S. who currently smoke or who have partners who smoke perceive the process of shared decision-making, their preferences, the perceived barriers and facilitators, and their perspective on currently-available screening tools.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES:

I. Understand how Chinese populations in the Unites States who currently smoke or who have partners who smoke perceive the process of shared health-related decision-making and their preferences in terms of role involvement, and the barriers to and facilitators of shared decision-making.

II. Evaluate current publicly available lung cancer screening tools from the perspective of Chinese adults who smoke or who have partners who smoke.

OUTLINE:

Participants attend an interview over 45-60 minutes and/or a focus group over 1.5 to 2 hours.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Robert J. Volk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants are recruited through several sources, including: (1) MD Anderson Cancer Center's (MDACC) Shared Decision Making Core Facility's registry ("REACH" Registry) of patients and caregivers who are willing to participate in decision support development studies (2) community health clinics serving Asian populations in Houston (3) Chinese religious or community groups/centers or at commercial locations catering to the Chinese community (4) social media or virtual groups that cater to Chinese communities of all ages or (5) snowball sampling through referrals from other participants.

Description

Inclusion Criteria:

  • Men and women who self-identify as Chinese
  • Live in the U.S. (either citizens or have lived in the U.S. for at least 5 years or more, i.e. long-term residents)
  • Age 50-80
  • Currently smokes or partner of a person who smokes
  • Speak English and/or Mandarin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational (interview, discussion)
Participants attend an interview over 45-60 minutes and/or a focus group over 1.5 to 2 hours.
Procedure: Discussion
Attend a focus group
Other Names:
  • Discuss
Other: Interview
Attend interview

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
How Chinese populations who smoke or have partners who smoke perceive the process of shared health-related decision-making
Time Frame: through study completion, an average of 1 year
Data analysis and data collection occurs simultaneously. Data is analyzed using a sequential approach to identify major and minor thematic areas. An initial codebook is developed based on the core questions within the interview guide, the literature, and initial coding of 3-4 transcripts. The internal validity of the codebook is established through detailed discussion between the coders and the research team. The reliability of the codebook is established in the first level of coding (descriptive codes) by double coding 25% of interviews and discussing any discrepancies to reach consensus on codes. Researchers analyze codes to identify the major and minor themes. Findings are summarized and illustrated using verbatim exemplars.
through study completion, an average of 1 year
Chinese populations' preferences in terms of role involvement, and the barriers to and facilitators of shared decision-making
Time Frame: through study completion, an average of 1 year
Data analysis and data collection occurs simultaneously. Data is analyzed using a sequential approach to identify major and minor thematic areas. An initial codebook is developed based on the core questions within the interview guide, the literature, and initial coding of 3-4 transcripts. The internal validity of the codebook is established through detailed discussion between the coders and the research team. The reliability of the codebook is established in the first level of coding (descriptive codes) by double coding 25% of interviews and discussing any discrepancies to reach consensus on codes. Researchers analyze codes to identify the major and minor themes. Findings are summarized and illustrated using verbatim exemplars.
through study completion, an average of 1 year
Current publicly available lung cancer screening tools from the perspective of Chinese adults who smoke or who have partners who smoke
Time Frame: through study completion, an average of 1 year
Data analysis and data collection occur simultaneously. Data is analyzed using thematic analysis. Based on the data from one focus group, an initial codebook is developed based on themes raised by participants. The data is grouped according to broad categories based on the aspects of the tool that the participants provided feedback on, such as: (1) visuals, (2) format of the tool, (3) information, (4) preferences in how risk is presented, (5) decision support, and (6) recommendations for improvement. The codebook is adjusted and refined to include codes that are identified from additional transcripts. Two coders code the transcripts after establishing the codebook's internal validity and reliability through consultation and assistance from other research team members. Findings are summarized and illustrated with verbatim quotes of participants.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert J Volk, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-0101 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-08583 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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