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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02492 | Registry Identifier | NCI CTRP | |
| CER-1306-03385 | Other Grant/Funding Number | Patient Centered Outcome Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard Educational Information | Active Comparator | Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Decision Aid | Behavioral | Participants will receive study materials including a video to watch about lung cancer screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Assessment at 1-week follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
1) History of lung cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Volk, PhD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Information and Quality Healthcare (IQH) | Ridgeland | Mississippi | 39157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32003822 | Derived | 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. | |
| 30010085 |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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After consent participants completed baseline assessments prior to randomization.
Recruitment Period: March 2015 to September 2016 from tobacco quitline new and former callers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Decision Aid | Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments |
| FG001 | Standard Educational Information | Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| One Week Follow-Up |
|
| |||||||||||||||||||||
| Three Month Follow-Up |
| ||||||||||||||||||||||
| Six Month Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Decision Aid | Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments |
| BG001 | Standard Educational Information |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of participants providing data at the 1-week follow-up, seventeen(17) of the participants did not answer the scale items and were therefore dropped from analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessment at 1-week follow-up. |
|
Adverse event data collected through 6 months participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Decision Aid | Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Operations Team, Office of VP Clinical Research | UT MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2016 | Sep 21, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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| Standard Educational Information | Behavioral | Participants will receive study materials including a booklet to read about lung cancer screening. |
|
|
| Follow-Up Assessments: Questionnaires | Behavioral | Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month |
|
|
| Derived |
| Lowenstein 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. |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participant Pack-Year Smoking History | Pack-year smoking history, where one pack-year is equivalent to smoking one pack of cigarettes daily (20 cigarettes) for one year. A 30-pack-year smoking history is an eligibility criterion for lung cancer screening. | Median | Inter-Quartile Range | pack-years |
|
| Participant Education Level | Count of Participants | Participants |
|
| Participant Health Insurance Status | Count of Participants | Participants |
|
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments |
| OG001 | Standard Educational Information | Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments |
|
|
| Primary | 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. | All participants providing data at the 1-week follow-up where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessment at 1-week follow-up. |
|
|
|
| Primary | 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. | Of participants providing data at the 1-week follow-up, one participant in the Standard Educational Information group did not answer the Values Clarity Subscale questions and was dropped from the analysis and where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessment at 1-week follow-up. |
|
|
|
| Secondary | 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. | For the participants providing data at the 1-week follow-up, no data was missing in either group. | Posted | Mean | Standard Deviation | percentage of correct responses | One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up. |
|
|
|
| 4 |
| 259 |
| 0 |
| 259 |
| 0 |
| 259 |
| EG001 | Standard Educational Information | Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments | 1 | 257 | 0 | 257 | 0 | 257 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| 3-Months |
|
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| 6-Months |
|
|