Cigarette Smoking-Related CarcinomaNCT05024955
Evaluating Shared Decision-Making for Lung Cancer Screening Among Chinese Populations in the United States
An observational study of Cigarette Smoking-Related Carcinoma, run by M.D. Anderson Cancer Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Discussion and Interview
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2021to 8 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Discussion, Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionProcedure or surgery
Also called Discuss
Attend a focus group
InterviewOther
Attend interview
| Study group | Role | What they receive |
|---|---|---|
| Observational (interview, discussion) | Participants attend an interview over 45-60 minutes and/or a focus group over 1.5 to 2 hours. Receives: Procedure: Discussion; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
How Chinese populations who smoke or have partners who smoke perceive the process of shared health-related decision-making
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.
Measured: 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
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.
Measured: 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
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start20 Jul 2021
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Why it stopped: 0 participants accrued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Volk, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024955
- Sponsor's protocol ID
- 2021-0101
- Other IDs
- NCI-2021-08583, 2021-0101
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Shared Decision-Making for Lung Cancer Screening Among Chinese Populations in the U.S.
- ClinicalTrials.gov ID
- NCT05024955
- Acronym / sponsor ID
- 2021-0101
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0 participants accrued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (interview, discussion) | – | Procedure: Discussion, Other: InterviewParticipants attend an interview over 45-60 minutes and/or a focus group over 1.5 to 2 hours. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussAttend a focus group | Procedure or surgery | Observational (interview, discussion) |
| InterviewAttend interview | Other | Observational (interview, discussion) |
Primary outcome
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Volk principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking-Related Carcinoma, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.