DOI: 10.5061/dryad.280gb5mv2
title: Commonly asked questions for lung cancer screening

description: Introduction. Lung cancer screening (LCS) can reduce lung cancer
 mortality; however, poor understanding of results may impact patient
 experience and follow-up. We sought to determine whether an informational
 handout accompanying LCS results can improve patient-reported outcomes and
 adherence to follow-up. Study Design. This was a prospective alternating
 intervention pilot trial of a handout to accompany LCS results delivery.
 Setting/Participants. Patients undergoing LCS in a multisite program over
 a 6-month period received a mailing containing either: 1) a standardized
 form letter of LCS results (control) or 2) the LCS results letter and the
 handout (intervention). Intervention. A two-sided informational handout on
 commonly asked questions after LCS was created through iterative
 mixed-methods evaluation with both LCS patients and providers. Outcome
 Measures. The primary outcomes of 1)patient understanding of LCS results,
 2)correct identification of next steps in screening, and 3)patient
 distress were measured through survey. Adherence to recommended follow-up
 after LCS was determined through chart review. Outcomes were compared
 between the intervention and control group using generalized estimating
 equations. Results. 389 patients were eligible and enrolled with survey
 responses from 230 participants (59% response rate). We found no
 differences in understanding of results, identification of next steps in
 follow-up or distress but did find higher levels of knowledge and
 understanding on questions assessing individual components of LCS in the
 intervention group. Follow-up adherence was overall similar between the
 two arms, though was higher in the intervention group among those with
 positive findings (p=0.007). Conclusions. There were no differences in
 self-reported outcomes between the groups or overall follow-up adherence.
 Those receiving the intervention did report greater understanding and
 knowledge of key LCS components, and those with positive results had a
 higher rate of follow-up. This may represent a feasible component of a
 multi-level intervention to address knowledge and follow-up for LCS.
description: Study
 Population This
 study was performed in a Seattle, Washington-based multisite program which
 oversees LCS provided by 4 tertiary care centers, 27 primary care clinics,
 specialty services, and self-referred patients. Screening is largely
 decentralized and managed by primary care providers. Central oversite is
 used to assist with scheduling and to standardize and track reporting.
 Screening results are sent to patients via standardized letter by the LCS
 program within 1 week of screening, with separate letter templates for
 each Lung-RADS category with additional information for those with “Other
 significant” or “S-findings.” Other results communication is at the
 discretion of the ordering physician and may include phone calls, visits,
 or communication through the electronic health record (EHR). Patients may
 also access their own LDCT reports through an EHR portal. Study Design
 This was a prospective,
 alternating-intervention controlled trial of the CAQ handout to accompany
 screening results. The CAQ handout was based partially on the American
 Thoracic Society “What is a lung nodule?” handout, modified and tailored
 based on patient focus groups and provider interviews. During the trial,
 post-screening letter contents alternated on a weekly basis between the
 standard Lung-RADS-based form letter (control) and the form letter with
 the CAQ handout (intervention). All screening patients undergoing LDCT
 across the system were included in this allocation scheme from December 7,
 2020, through June 14, 2021 (with the exception of a 5-week pause for EHR
 transition).  One week
 after sending the results, a second mailing was sent to participants,
 including an introductory letter, an information statement, a $5
 incentive, the survey instrument and a stamped return envelope. At this
 stage, participants who did not have a valid mailing address (n=12), were
 identified as non-English speaking (n=6) or had cognitive impairment (n=2)
 documented in the EHR, were excluded from the study. If surveys were not
 returned within 2 weeks, a study coordinator called the patient, reminding
 them to return the survey and offered to complete the survey with them by
 phone. Up to three reminder phone calls were provided. This was a
 partially blinded study. Ordering providers were unaware of the study
 assignment, as were research coordinators who assisted participants and
 completed data entry. This study was approved by the Fred Hutchinson
 Cancer Center Institutional Review Board with a waiver of informed
 consent. The CAQ handout is
 a single front-and-back handout. The handout covers topics such as: lung
 nodules and common causes, next steps after screening, reassurance for
 waiting for follow-up or annual scans, common incidental findings and
 smoking cessation information. The handout provides infographics on lung
 nodule size and the Lung-RADS categorization system. The CAQ handout was
 created to increase understanding of LCS results, improve adherence to
 screening follow-up and relieve anxiety around results given the high
 likelihood of lung nodules and incidental findings on LDCT.
 Measures
 The primary outcomes were defined by
 a 94-item survey created by the study team and piloted by two research
 coordinators. Topical areas of the survey included: demographics and
 overall health, assessment of understanding of LCS, assessment of lung
 cancer risk, understanding of next screening steps, and distress following
 screening measured by the Impact of Event Scale (IES). Those who
 identified on the survey that they received the CAQ completed additional
 questions to assess the acceptability and appropriateness of the CAQ,
 using the validated acceptability of intervention measure (AIM) and
 intervention appropriateness measure (IAM). We also followed patients longitudinally
 for at least 15 months after their enrollment to determine the differences
 in adherence to recommended LCS follow-up. LCS follow-up was ascertained
 on all participants who were enrolled in the study, whether or not they
 returned a survey, through review of the EHR with each participant
 reviewed by two team members (MT and MS). Adherence to follow-up was
 standardized by Lung-RADS recommendation, consistent with prior study; for
 patients with Lung-RADS 1 or 2: a chest CT (low-dose or diagnostic)
 completed within 11-15 months, for Lung-RADS 3: a chest CT completed
 within 5-8 months, for Lung-RADS 4A: a chest CT completed within 4 months,
 and for Lung-RADS 4B: a diagnostic image, procedure or provider follow-up
 consultation within 1 month. Participants who died or had documented move
 out of area or transferred their care (n=3) were excluded from this
 analysis. The dataset was
 maintained in RedCap data repository.
description: ## Commonly Asked Questions (CAQ) in Lung Cancer Screening Study This is a
 study of 410 participants who underwent screening in 2020-2021 as a part
 of a trial in which participants were randomized to either: receive a CAQ
 with their results or receive usual care. Data presented includes
 participant characteristics, survey responses from respondents and
 follow-up lung cancer screening outcomes. ## Description of the data and
 file structure The data are presented with full description of the data
 columns as the label. The file is a CSV file. Each row is a unique
 participant and each column represents a variable Variable description:
 Each participant is labeled with a unique four digit study ID starting
 with LCS. Eligibility for inclusion in the study is defined as 1/0. The
 treatment arm (itt_group) is either the intervention (CAQ) or the control.
 The study_responder column describes whether they were enrolled in the
 study or whether they declined to participate (a non-respondent). The
 pp_group describes whether, if in the CAQ group, they reported reading the
 intervention. The next three columns describe whether this was a baseline
 lung cancer screening (LCs0 exam, their lung RADS score (defined as 1, 2,
 3, 4A, 4B or 4X) and whether they were adherent to follow-up
 recommendations (1/0). The next columns include data from 3 data streams,
 the lung cancer screening registry (starting with "registry"),
 the survey (starting with "survey"), EHR data used to determine
 their PLCOm2012 model score (starting plcom2012). Demographics (male sex,
 age, race, hispanic/latino ethnicity, insurance status, current smoking
 status and pack-years of smoking history) are recorded from the lung
 cancer screening registry. Male sex, age, race, and hispanic/latino
 ethnicity are also recorded from the survey. Other survey variables are
 described in detail below: survey_work: participants current employment
 status defined as employed/student, retired, disabled, unemployed/other
 survey_education: highest level of education defined as: high school (HS)
 or less, some college, college graduate or more survey_insurance_status:
 current insurance status defined as combinations of private, medicare,
 medicaid or other survey_current_smoker: current smoking status (1/0)
 survey_pack_years: participant estimate of lifetime pack-years of
 cigarettes smoked Variables used to calculate the PLCO model are similar
 to the above. They also include body mass index (BMI), chronic obstructive
 pulmonary disease history (1/0), personal history of lung cancer (1/0),
 family history of lung cancer (1/0), smoking intensity (cigarettes per
 day), smoking years (number of years smoking), quit years (number of years
 since quit. The variable plcom2012_lung_cancer_risk_6 year gives the
 percent risk (represented as a decimal) for lung cancer development in the
 next 6 years from the placem2012 model. To protect subjects, BMI is
 presented as a categorical variable: BMI&lt;18.5 is listed as
 "underweight," BMI 18.5-24.9 is listed as "Healthy
 weight," BMI 25-29.9 is listed as "Overweight" and BMI 30
 or greater listed as "Obesity." Specific BMI measurements are
 available at request from the author. Survey_primary_1 is the response to
 the question "Did you understand your lung cancer screening
 results?" and recorded on the 4-point Likert scale strongly agree,
 somewhat agree, somewhat disagree and strongly disagree. Survey_primary_2
 is recorded as 1/0 based on matching a participants response to "what
 is your next step for screening" and the correct response based on
 their Lung-RADS. Survey_primary_3 is the Impact of Events Severity scale
 from composite questions which ranges 0-100. Survey_secondary_1-6 are the
 secondary outcomes. All question stems are as recorded in the variable
 name. All responses are on the same 4-point Likert scale as above. The
 survey_caq_acceptability score is the mean score of the 4 item AIM
 (Acceptability of intervention measure ) from 1-5. It is the mean of the 4
 acceptability items which follow which are all on a 1 (completely
 disagree) to 5 (complete agree) scale. The
 survey_caq_appropriateness_score is the means score of the 4 item IAM
 (Intervention Appropriateness measure) from 1-5. It is the mean of the 4
 appropriateness items which follow which are all on a 1 (completely
 disagree) to 5 (completely agree) scale. Missing data. All empty cells are
 replaced with "null." Cells with the term null largely represent
 survey and follow-up fields for non-respondents/participants. In
 respondents these may represent rare instances of "missing data"
 where survey respondents declined to answer a survey question.
 De-identified data. All direct identifiers were removed from the dataset.
 Only 3 indirect identifiers (age, race/ethnicity variables and gender) are
 included in the data-set. Additional responses that were indirect
 identifiers were removed from the published data set. ## Sharing/Access
 information Links to other publicly accessible locations of the data: *
 There are no other publicly accessible locations of the data Data was
 derived from the following sources: * Survey responses, lung cancer
 screening registry and the electronic health record ## Code/Software N/A.
 All analysis for the original manuscript was performed in R.