Lung CancerNCT02286713
PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening
A study testing Patient Decision Aid, Standard Educational Information and Follow-Up Assessments: Questionnaires in people with Lung Cancer and Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening. Read more about this study
- Who is it for?
- Ages 55 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Smoking Cessation, Tobacco Use Cessation
- What is being tested?
- Patient Decision Aid, Standard Educational Information and Follow-Up Assessments: Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 55 to 77 years of age.
- Participants must speak English.
- Current smoker or quit smoking within the past 15 years.
- At least a 30 pack-year smoking history.
Who cannot join
- 1) History of lung cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Information and Quality Healthcare (IQH)
Ridgeland, Mississippi, 39157
About this study
Official title: Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.
Read the detailed description
This is the second phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (LDCT). The aim of this phase is to compare outcomes for promoting informed screening decisions about lung cancer screening in a randomized trial of patients who smoke recruited through state-based smoking cessation quitlines, where patients will be randomly assigned to the updated patient decision aid or to standard educational materials on lung cancer screening.
- Conditions
- Lung Cancer, Smoking Cessation, Tobacco Use Cessation
- Being tested
- Patient Decision Aid, Standard Educational Information, Follow-Up Assessments: Questionnaires
- Keywords
- Lung Cancer Screening, heavy smokers, state-based smoking cessation quitlines, patient decision aid, low-dose computed tomography, LDCT, standard educational information
- Medical subject headings
- Lung Neoplasms, Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Decision AidBehavioural
Also called Video, DVD
Participants will receive study materials including a video to watch about lung cancer screening
Standard Educational InformationBehavioural
Also called Booklet
Participants will receive study materials including a booklet to read about lung cancer screening.
Follow-Up Assessments: QuestionnairesBehavioural
Also called Survey
Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Aid | Active comparator | Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments Receives: Behavioral: Patient Decision Aid; Behavioral: Follow-Up Assessments: Questionnaires |
| Standard Educational Information | Active comparator | Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments Receives: Behavioral: Standard Educational Information; Behavioral: Follow-Up Assessments: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Value: Preparation for Decision Making© Scale
The Preparation for Decision Making© Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. The scale is scored by summing the 10 items and dividing by 10. Scores are then converted to a 0-100 scale by subtracting 1 and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making. For this study, researchers used the patient version of the Preparation for Decision Making© scale, adapted for Lung Cancer Screening (LCS) context.
Measured: Assessment at 1-week follow-up.
Mean Value: Informed Subscale of the Decisional Conflict Scale©
A 3-item subscale that measures the degree to which the patient feels informed in making a decision about lung cancer screening. Total scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed) related to making a decision. The scale was adapted for the LCS context.
Measured: Assessment at 1-week follow-up.
Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©
A 3-item subscale that measures the degree to which the patient feels clear about his or her values related to the lung cancer screening decision, including values about the harms and benefits. Total scores range from 0 (feels extremely clear about personal value for benefits and risks/side effects of screening) 100 (feels extremely unclear about personal value for benefits and risks/side effects of screening) related to making a decision. The scale was adapted for the LCS context.
Measured: Assessment at 1-week follow-up.
Secondary outcomes (1)
Mean Value: Knowledge of Lung Cancer Screening
A 12-item, self-report measure of the patient's knowledge of facts related to lung cancer and lung cancer screening, including the harms and benefits of testing. The knowledge scale yields a single score, representing the percentage of correct responses (ranging from 0% to 100% correct). Higher scores indicate greater knowledge.
Measured: One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startMar 2015
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Robert Volk, PhD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286713
- Sponsor's protocol ID
- 2014-0628
- Other IDs
- NCI-2014-02492, CER-1306-03385
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2014
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Volk RJ, Lowenstein LM, Leal VB, Escoto KH, Cantor SB, Munden RF, Rabius VA, Bailey L, Cinciripini PM, Lin H, Housten AJ, Luckett PG, Esparza A, Godoy MC, Bevers TB. Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920362. doi: 10.1001/jamanetworkopen.2019.20362.
PubMed 32003822Lowenstein LM, Escoto KH, Leal VB, Bailey L, Bevers TB, Cantor SB, Cinciripini PM, Jacobs LE, Esparza A, Godoy MC, Housten AJ, Lin H, Luckett P, Munden RF, Rabius V, Volk RJ. Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned. Contemp Clin Trials. 2018 Sep;72:26-34. doi: 10.1016/j.cct.2018.07.007. Epub 2018 Jul 20.
PubMed 30010085
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
- ClinicalTrials.gov ID
- NCT02286713
- Acronym / sponsor ID
- 2014-0628
- Conditions
- Lung Cancer, Smoking Cessation, Tobacco Use Cessation
- Keywords
- Lung Cancer Screening, heavy smokers, state-based smoking cessation quitlines, patient decision aid, low-dose computed tomography, LDCT, standard educational information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Mar 2015 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.
Detailed description
This is the second phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (LDCT). The aim of this phase is to compare outcomes for promoting informed screening decisions about lung cancer screening in a randomized trial of patients who smoke recruited through state-based smoking cessation quitlines, where patients will be randomly assigned to the updated patient decision aid or to standard educational materials on lung cancer screening.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Aid | Active comparator | Behavioral: Patient Decision Aid, Behavioral: Follow-Up Assessments: QuestionnairesDecision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments |
| Standard Educational Information | Active comparator | Behavioral: Standard Educational Information, Behavioral: Follow-Up Assessments: QuestionnairesStudy materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 55 to 77 years of age.
- Participants must speak English.
- Current smoker or quit smoking within the past 15 years.
- At least a 30 pack-year smoking history.
Key exclusion criteria (1 listed)
- 1) History of lung cancer.
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 |
|---|---|---|
| Patient Decision AidAlso: Video, DVDParticipants will receive study materials including a video to watch about lung cancer screening | Behavioural | Patient Decision Aid |
| Standard Educational InformationAlso: BookletParticipants will receive study materials including a booklet to read about lung cancer screening. | Behavioural | Standard Educational Information |
| Follow-Up Assessments: QuestionnairesAlso: SurveyFollow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month | Behavioural | Patient Decision Aid, Standard Educational Information |
Primary outcome
Mean Value: Preparation for Decision Making© Scale
Time frame: Assessment at 1-week follow-up.
The Preparation for Decision Making© Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. The scale is scored by summing the 10 items and dividing by 10. Scores are then converted to a 0-100 scale by subtracting 1 and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making. For this study, researchers used the patient version of the Preparation for Decision Making© scale, adapted for Lung Cancer Screening (LCS) context.
Mean Value: Informed Subscale of the Decisional Conflict Scale©
Time frame: Assessment at 1-week follow-up.
A 3-item subscale that measures the degree to which the patient feels informed in making a decision about lung cancer screening. Total scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed) related to making a decision. The scale was adapted for the LCS context.
Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©
Time frame: Assessment at 1-week follow-up.
A 3-item subscale that measures the degree to which the patient feels clear about his or her values related to the lung cancer screening decision, including values about the harms and benefits. Total scores range from 0 (feels extremely clear about personal value for benefits and risks/side effects of screening) 100 (feels extremely unclear about personal value for benefits and risks/side effects of screening) related to making a decision. The scale was adapted for the LCS context.
1 secondary outcome
Mean Value: Knowledge of Lung Cancer Screening
Time frame: One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32003822Volk RJ, Lowenstein LM, Leal VB, Escoto KH, Cantor SB, Munden RF, Rabius VA, Bailey L, Cinciripini PM, Lin H, Housten AJ, Luckett PG, Esparza A, Godoy MC, Bevers TB. Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920362. doi: 10.1001/jamanetworkopen.2019.20362.
- Derived from this study: PubMed 30010085Lowenstein LM, Escoto KH, Leal VB, Bailey L, Bevers TB, Cantor SB, Cinciripini PM, Jacobs LE, Esparza A, Godoy MC, Housten AJ, Lin H, Luckett P, Munden RF, Rabius V, Volk RJ. Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned. Contemp Clin Trials. 2018 Sep;72:26-34. doi: 10.1016/j.cct.2018.07.007. Epub 2018 Jul 20.
- University of Texas MD Anderson Cancer Center Official WebsiteLink 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 Volk, PhD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Decision Aid, Standard Educational Information and Follow-Up Assessments: Questionnaires in people with Lung Cancer and Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Value: Preparation for Decision Making© Scale (time frame: Assessment at 1-week follow-up.). 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?
On the ClinicalTrials.gov record for NCT02286713, which also lists 2 linked publications.
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 1 Feb 2021.