Lung Cancer
Conditions
Keywords
Lung cancer screening, Social media, Tailored interventions
Brief summary
LungTalk and leveraging Facebook-targeted Advertisement (FBTA) addresses the call to develop and test multi-level, cancer communication interventions using innovative methods and designs. The study's long term goal is to increase lung cancer screening uptake among appropriate, high-risk individuals nationwide.
Interventions
BEHAVIORALLungTalk
LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool.
BEHAVIORALNon-tailored intervention - Standard of practice
ACS Lung Screening Informational Video
Sponsors
National Cancer Institute (NCI)
Hackensack Meridian Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* ≥20-pack-year smoking history; * Individuals who currently smoke or quit smoking within the past 15 years
Exclusion criteria
* Previously undergone LDCT for early detection of lung cancer, have a lung nodule or nodules that are currently being followed * Has ever been diagnosed with lung cancer * Individuals with impaired decision-making (because our primary outcome is decision-making, we will not include individuals with impaired decision-making)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaching Screening Eligible Individuals Via Social Media - Reach | 11-month period ad remained active on Facebook | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of people who saw the FBTA at least once. |
| Reaching Screening Eligible Individuals Via Social Media - Link Clicks | 11-month period ad remained active on Facebook | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of clicks on the link within the FBTA that led to the REDCap survey platform of the study. |
| Reaching Screening Eligible Individuals Via Social Media - Impressions | 11-month period ad remained active on Facebook | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of times the FBTA was on screen (may include multiple views of the ad by the same person/people). |
| Effectiveness of LungTalk - Knowledge Assessment | At baseline | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being No Knowledge and 9 being Complete knowledge. |
| Effectiveness of LungTalk - Perceived Risk | At baseline | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer). |
| Effectiveness of LungTalk - Perceived Benefits | At baseline | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits). |
| Effectiveness of LungTalk - Perceived Barriers | At baseline | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers). |
| Effectiveness of LungTalk - Self-Efficacy | At baseline | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy). |
| Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | At baseline | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. |
| Effectiveness of LungTalk - Screening Uptake | At baseline | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). |
Countries
United States
Participant flow
Pre-assignment details
We initially had 512 participants enroll in the study. Still, only 483 were randomized to the study arms, as the remaining 29 participants were lost to follow-up after failing to complete the baseline survey upon enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Consented Patients to the Study Results are reported in aggregate because the baseline characteristics were collected prior to randomization, and there were no arm-specific differences at this stage. | 483 |
| Total | 483 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 13 |
Baseline characteristics
| Characteristic | Consented Patients to the Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 214 Participants |
| Age, Categorical Between 18 and 65 years | 269 Participants |
| Age, Continuous | 63.3 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 453 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 70 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 376 Participants |
| Region of Enrollment United States | 483 participants |
| Sex/Gender, Customized Female | 246 Participants |
| Sex/Gender, Customized Male | 236 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 240 | 0 / 243 |
| other Total, other adverse events | 0 / 240 | 0 / 243 |
| serious Total, serious adverse events | 0 / 240 | 0 / 243 |
Outcome results
Primary
Effectiveness of LungTalk - Knowledge Assessment
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being No Knowledge and 9 being Complete knowledge.
Time frame: At baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Knowledge Assessment | 4 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Knowledge Assessment | 4 score on a scale |
Primary
Effectiveness of LungTalk - Knowledge Assessment
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being No Knowledge and 9 being Complete knowledge.
Time frame: At one week from baseline survey completion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Knowledge Assessment | 6 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Knowledge Assessment | 6 score on a scale |
Primary
Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider.
Time frame: At baseline
Population: The number of participants who reported having discussed with their health care provider regarding lung screening at any time prior to their enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | 91 Participants |
| Non-tailored Intervention | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | 92 Participants |
Primary
Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider.
Time frame: At 6 months from baseline survey completion
Population: The number of participants who discussed with their health care provider about lung screening since viewing the program, captured at 6 months post survey completion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | 193 Participants |
| Non-tailored Intervention | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | 161 Participants |
Primary
Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider.
Time frame: At one week from baseline survey completion
Population: The number of participants who reported having discussed with their health care provider regarding lung screening since viewing the program.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | 113 Participants |
| Non-tailored Intervention | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | 115 Participants |
Primary
Effectiveness of LungTalk - Perceived Barriers
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers).
Time frame: At one week from baseline survey completion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Perceived Barriers | 25 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Perceived Barriers | 25 score on a scale |
Primary
Effectiveness of LungTalk - Perceived Barriers
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers).
Time frame: At baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Perceived Barriers | 33 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Perceived Barriers | 31 score on a scale |
Primary
Effectiveness of LungTalk - Perceived Benefits
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits).
Time frame: At baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Perceived Benefits | 20 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Perceived Benefits | 19 score on a scale |
Primary
Effectiveness of LungTalk - Perceived Benefits
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits).
Time frame: At one week from baseline survey completion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Perceived Benefits | 20.5 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Perceived Benefits | 21 score on a scale |
Primary
Effectiveness of LungTalk - Perceived Risk
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer).
Time frame: At baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Perceived Risk | 6 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Perceived Risk | 6 score on a scale |
Primary
Effectiveness of LungTalk - Perceived Risk
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer).
Time frame: At one week from baseline survey completion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Perceived Risk | 7 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Perceived Risk | 7 score on a scale |
Primary
Effectiveness of LungTalk - Screening Uptake
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance).
Time frame: At 6 months from baseline survey completion
Population: The number of participants who had a lung scan (low dose CAT scan) to screen for lung cancer since joining this study (captured at 6 months post baseline survey completion).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Screening Uptake | 134 Participants |
| Non-tailored Intervention | Effectiveness of LungTalk - Screening Uptake | 125 Participants |
Primary
Effectiveness of LungTalk - Screening Uptake
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance).
Time frame: At baseline
Population: The number of participants who had a lung scan (low dose CAT scan) to screen for lung cancer prior to their enrolment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Screening Uptake | 67 Participants |
| Non-tailored Intervention | Effectiveness of LungTalk - Screening Uptake | 65 Participants |
Primary
Effectiveness of LungTalk - Screening Uptake
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance).
Time frame: At one week from baseline survey completion
Population: The number of participants who had a lung scan (low dose CAT scan) to screen for lung cancer since joining this study (captured at 1 week post survey completion).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Screening Uptake | 48 Participants |
| Non-tailored Intervention | Effectiveness of LungTalk - Screening Uptake | 45 Participants |
Primary
Effectiveness of LungTalk - Self-Efficacy
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy).
Time frame: At one week from baseline survey completion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Self-Efficacy | 33 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Self-Efficacy | 33 score on a scale |
Primary
Effectiveness of LungTalk - Self-Efficacy
The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy).
Time frame: At baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Effectiveness of LungTalk - Self-Efficacy | 31 score on a scale |
| Non-tailored Intervention | Effectiveness of LungTalk - Self-Efficacy | 31 score on a scale |
Primary
Reaching Screening Eligible Individuals Via Social Media - Impressions
Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of times the FBTA was on screen (may include multiple views of the ad by the same person/people).
Time frame: 11-month period ad remained active on Facebook
Population: Facebook-provided metrics were collected at the aggregate level (impressions, reach, engagements, and clicks). Because individual-level identifiers were not captured, it is not possible to report a precise 'number of people analyzed' from the platform; therefore, all Facebook-derived outcomes are reported as aggregate counts and rates. The total reach number on FB which is 3,109,482 is used instead.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Reaching Screening Eligible Individuals Via Social Media - Impressions | 3109482 number of times the add was viewed |
Primary
Reaching Screening Eligible Individuals Via Social Media - Link Clicks
Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of clicks on the link within the FBTA that led to the REDCap survey platform of the study.
Time frame: 11-month period ad remained active on Facebook
Population: Overall Number of Participants Analyzed represents the number of participants screened for study interest prior to enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Reaching Screening Eligible Individuals Via Social Media - Link Clicks | 24816 unique clicks |
Primary
Reaching Screening Eligible Individuals Via Social Media - Reach
Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of people who saw the FBTA at least once.
Time frame: 11-month period ad remained active on Facebook
Population: Facebook-provided metrics were collected at the aggregate level (impressions, reach, engagements, and clicks). Because individual-level identifiers were not captured, it is not possible to report a precise 'number of people analyzed' from the platform; therefore, all Facebook-derived outcomes are reported as aggregate counts and rates. The total reach number on FB which is 3,109,482 is used instead.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unique Facebook Users Who Saw the Add | Reaching Screening Eligible Individuals Via Social Media - Reach | 1048191 participants |