A Multimethod Evaluation of Tobacco Treatment Trial Recruitment Messages for Current Smokers Recently Diagnosed With Cancer: Pilot Factorial Randomized Controlled Trial
Phase: NA
Conditions: Tobacco Smoking, Health Behavior
Sponsor: University of Oklahoma

 
 
  
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A Multimethod Evaluation of Tobacco Treatment Trial Recruitment 
Messages for Current Smokers Recently Diagnosed With Cancer: 
Pilot Factorial Randomized Controlled Trial 
 
NCT #: N/A 
 
Document Date: 11/19/2020 
 

 
Partners Human Subjects Research Application 
Form 
 
 Filename: Protocol Summary 
Version Date:  June 1, 
2005  
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PRINCIPAL/OVERALL INVESTIGATOR 
Elyse R. Park, PhD, MPH 
 
PROTOCOL TITLE
Recruitment messages using Vidscrip 
 
FUNDING
1R01CA218123 - 01A1 
 
VERSION DATE 
11.19.20 
 
SPECIFIC AIMS 
 
There is growing support for the delivery of evidence-based smoking cessation treatment at the 
time of cancer screening and/or after a patient receives a recent cancer diagnosis. However, 
there remain barriers to recruiting eligible patients to cessation trials in a cost-effective and 
scalable manner. One way to overcome these barriers is to employ digital recruitment strategies 
that utilize video-based recruitment messages to describe the benefits of participating in the 
trial. In order to determine the optimal components that should be included in these recruitment 
messages, rigorous formative evaluation must first be conducted. Therefore, this study will pilot 
test different components of study recruitment videos that will be employed in two future 
smoking cessation clinical trials.  
Additionally, individuals who identify as Hispanic or Latino are historically underrepresented in 
smoking cessation clinical trials. Despite there being high levels of smoking among some sub-
groups, engagement with smoking cessation remains low. We aim to test the most salient 
messages in informational recruitment videos for a smoking cessation clinical trial tailored for 
Hispanic/Latinos. We will refer to this as Survey 1a.  
We propose to conduct an online survey experiment through Qualtrics Panels and Survey 
Sampling International (SSI), online panel companies. The survey will test a series of videos, 
delivered through the Vidscrip platform, to promote a smoking cessation trial (Smokefree 
Support 2.0) to patients who were recently diagnosed with cancer.  
Broadly, the study aims are as follows: 
Aim 1: To determine the optimal recruitment video components for a smoking cessation 
trial for recently diagnosed cancer patients (Smokefree Support 2.0) 
Aim 2: To identify, qualitatively, aspects of each recruitment video that can be improved 
upon.  
BACKGROUND AND SIGNIFICANCE 
 
The study investigators have considerable experience in directing the successful execution of 
dissemination and implementation studies of evidence-based tobacco cessation treatments, as 
well designing and developing recruitment messages through online message experiments.  

 
 
  
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Dr. Park has extensive experience in integrating evidence-based tobacco treatments within the 
Partners HealthCare Network. She has completed a pilot tobacco non-randomized controlled 
clinical trial (5R03CA130722-02) which showed promising feasibility and efficacy for delivering 
an evidence-based intensive tobacco treatment (IT; 9 motivational coaching sessions plus 
varenicline) to lung cancer patients at Massachusetts General Hospital (MGH). Dr Park was a 
member of the committee to increase delivery of tobacco treatment at NCI-Designated Cancer 
Centers based on the 2008 Clinical Guidelines for Treating Tobacco Dependence. Dr. Park has 
directed multi-site tobacco treatment motivational trials among low income smokers as well as 
research examining cancer care in the setting of nicotine dependence. Dr. Park was also PI on 
a study involving the CanCORS cohort and factors associated with continued smoking 
 
Dr. Haas is a licensed/credentialed general internist with research expertise in developing and 
evaluating clinical practice-based interventions, particularly using health IT. She recently 
completed an intervention for low income and minority smokers that included nicotine 
replacement, tobacco coaching and systematic screening and referral for social determinants of 
health. She collaborated with Drs. Park and Rigotti on this project. She is currently PI of an NCI-
funded PROSPR grant that collaborates across 7 centers to define common data elements for 
screening and cancer outcomes. 
 
Dr. Rigotti is a licensed/ credentialed general internist and has extensive experience integrating 
tobacco treatment into inpatient settings. She is currently PI of an NIH-funded comparative 
effectiveness trial of 2 post-discharge interventions for hospitalized smokers. Dr. Park oversees 
the motivational coaching design for this study. Dr. Rigotti has extensive experience testing 
pharmacological treatment for medical patients, including hospitalized smokers, and recently 
was site PI for an RCT that demonstrated the efficacy and safety of varenicline in patients with 
cardiovascular disease.  
 
Dr. Neil is a postdoctoral research fellow and a health communication expert. He has extensive 
experience testing message design theories and utilizing persuasive message appeals to target 
behavior change and reduce cancer disparities. His recent publications in Journal of Cancer 
Education, Journal of the National Cancer Institute, and the Oxford Research Encyclopaedia of 
Communication focus on experimentally testing message strategies that encourage patient 
participation in cancer clinical trials, all of which have provided him with prior experience to help 
conduct this study. 
 
RESEARCH DESIGN AND METHODS 
Survey  
A nationally representative sample of approximately 81 participants will be recruited from SSI. 
The survey will employ a 23 factorial design plus control condition, with participants randomized 
to one of 9 videos. The videos will consist of 9 intervention proportions, based on a 3-factor fully 
crossed factorial design to efficiently test components that vary on 1) threat of continuing to 
smoke (proximal vs. distal frame), 2) benefits of quitting (gain vs. loss frame), 3) benefits of 
participating in Screen ASSIST (gain vs. loss frame), and a kernel message control condition 
with no message factors included.  
 
Survey inclusion and exclusion criteria: 

 
 
  
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Participants will be screened eligible if they meet the following criteria by self-reporting:  
language (English speaking), age (> 18), smoking status (puff within the past 30 days), and 
cancer status (diagnosed with cancer in the past 24 months). 
Video development and recording 
The videos for the surveys will be developed in collaboration with Deborah Kim, from MGH 
Marketing Dept. The approved script will be recorded in segments, in order to develop the 
differing video conditions. The videos for the survey will include an oncologist. Videos will be 
stored on a study-specific account on Vidscrip.com and the videos will be embedded into the 
survey platforms.  
Video content 
Participants will be prompted to review a study for an upcoming smoking cessation trial for 
patients who have similar characteristics and smoking and medical history as they do. The 
videos for survey will last approximately 3 minutes and introduce each respective cessation 
study, outlining the benefits of participating in the study.  
Outcome Assessment 
The survey employs an experimental design, in which participants will provide quantitative 
feedback through a series of survey responses, as well as qualitative feedback through open-
ended questions. Both forms of data will be analyzed and merged to provide a holistic 
evaluation of the videos. There will be no follow-up data or connection to medical records. 
Survey responses will be completely de-identified. Please see survey instruments for full 
measures of data collection.  
The study presents minimal risk to participants and does not expose participants to any 
unnecessary risk. To ensure participant understanding of the study prior to consenting, a 
description of the aims and length of the survey (approximately 15 minutes) will be detailed in 
the informed consent prior to beginning the survey. As with any behavioral research study, it is 
possible that participants may feel some psychological discomfort as they are presented with 
information about cessation within the video; however, we expect this likelihood of this to be 
minimal and the participant can stop participating in the survey at any time. 
To ensure patient understanding of the study prior to consenting, there will be an explanation of 
the study on the initial screen of the survey. Subjects who wish to leave the study after 
enrolment may drop out at of the survey at time. MGH-directed research activities have been 
designed to carefully consider the safety of subjects, and all study staff have completed the 
requisite MGH/Partners human subjects trainings prior to being added as study staff. 
FORESEEABLE RISKS AND DISCOMFORTS 
Psychological Risks 
Individuals may find it stressful to answer questions and discuss their smoking behaviors. The 
risks associated with these discussions are minimal, especially when compared to the benefits 
of smoking cessation.  As with online video experiment, there is the small chance that a 
participant will be negatively affected by the content of the video. However, the script used for 
the video has been constructed in partner with, and vetted by, trained and certified tobacco 
treatment specialists and smoking cessation specialists. 
EXPECTED BENEFITS 

 
 
  
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The expected benefits to the individual for participating in this study are that they will learn 
valuable information about the benefits of smoking cessation. They will be told about the 
benefits of cessation after a recent cancer diagnosis. At the end of the survey, they will also be 
offered the opportunity to click on a link that will direct them to clinicaltrials.gov to find a smoking 
cessation trial, if they wish. Therefore, the overall risk to benefit ratio for the participant is 
favorable. Furthermore, the results of the study will also benefit future patients who smoke, as 
the study determines the most effective messages to recruit patients to a smoking cessation 
study.  
EQUITABLE SELECTION OF SUBJECTS 
Patients will be recruited through Qualtrics panels and SSI and randomized to one of 9 videos. 
Built into the survey logic for the survey, each participant will have equal opportunity to be 
randomized to any one of the videos, respectively. The survey randomization will randomly 
assign each participant to a condition using a computer-generated program. The program will 
generate a schedule of randomization IDs and treatment assignments in balanced blocks. 
Only English-speaking men and women will be recruited and enrolled as the videos are 
recorded in English. Children will not be enrolled because they are not eligible for lung cancer 
screening.  
 
These surveys are pilot-testing the recruitment videos that will be used in the upcoming clinical 
trials. Only videos recorded in English will be tested in this study as we want to first evaluate the 
content of these videos to determine the most effective components for a recruitment video.  
 
RECRUITMENT PROCEDURES 
Participants will be recruited from Qualtrics Panels and Survey Sampling International, 
proprietary opt-in panel companies. Qualtrics and SSI recruit participants from various sources, 
including website intercept recruitment, member referrals, targeted email lists, gaming sites, 
customer loyalty web portals, permission-based networks, and social media, etc. Consumer 
panel members’ names, addresses, and dates of birth are typically validated via third-party 
verification measures prior to their joining a panel. B2B participants are subject to additional 
quality control measures such as LinkedIn matching, phone calls to the participant’s place of 
business, and other third-party verification methods (TrueSample, RelevantID, Verity, etc.). The 
study investigators pay Qualtrics and SSI to complete these procedures. 
Qualtrics and SSI compensate patients based on how unique they are as a study participant 
(i.e., demographics, medical history, etc.). There official explanation reads: Our panelists join 
from a variety of sources. They may be airline customers who chose to join in reward for 
SkyMiles, retail customers who opted in to get points at their favorite retail outlet, or general 
consumers who participate for cash or gift cards, etc. When participants are invited to take a 
survey, they are informed what they will be compensated. Because each respondent is 
compensated differently, it would be inappropriate to provide a specific amount for how much 
they will be compensated in the informed consent document.  
However, consultation with both companies has confirmed that the reimbursement value for 
completing the survey will be under $5.  
CONSENT PROCEDURES 
Patients will be presented with an initial ‘Information Sheet’ on the survey where they will read 
the details of the study. The survey will be administered online, and the patient must confirm 
that they have read and understand the text on the Information Sheet to move forward with the 
survey.  

 
 
  
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DATA AND SAFETY MONITORING 
Data collection for this survey will be completed in approximately three weeks after launch, 
there will be a limited period data collection monitoring. In addition, there is minimal risk for 
participants and the study team will never have direct contact with the participants, so 
monitoring will primarily be conducted through as a means of data quality checks. However, 
throughout the study, if any adverse events or serious adverse events are reported as a result 
of responding to the survey, this information will be reported in a timely fashion to the IRB. The 
PIs are responsible for protecting the rights, safety, and welfare of the study patients and for 
ensuring that the study is conducted in accordance with the IRB-approved protocol and 
applicable regulations and requirements of the IRB. 
 
Data monitoring plan: All study procedures and data collection will be piloted before the trial 
begins.This will firstly be done internally, then a 10% sample pilot launch will be conducted by 
Qualtrics and SSI externally to confirm that data is collected as expected. To further prevent the 
loss of confidentiality, all electronic information stored on the main database within the 
MGH/Partners Healthcare System, Inc. firewall, is password protected, and is protected by anti-
virus software. Only study staff will have access to the study data on Shared File Areas. 
However, this data will not have Dr. Park will review the data for quality assurance and discuss 
data quality problems with the PIs. Data quality (including visits completed during the 
intervention window, data missingness, and recruitment rates) will be monitored monthly. 
Interim data analysis will be conducted throughout the trial and results will be reported in the 
annual NIH progress report. In addition, the RAs will participate in weekly study evaluation 
meetings to review any difficulties that arise with survey administration and the status of follow-
up survey and biochemical collection. 
 
The Principal Investigators will be responsible for the reporting of any adverse events to the 
Institutional Review Board. The Partners IRB requires that serious adverse events are to be 
reported to the IRB as soon as possible, within 5 working days/7 calendar days of the date the 
investigator first becomes aware of the problem. Non-serious adverse events are to be reported 
within 20 working days.   
MONITORING AND QUALITY ASSURANCE 
Data quality (including visits completed during intervention window, data missingness, and 
recruitment rates) will be monitored weekly by the Dr. Neil, and systemic data problems will be 
reported to the PIs. Dr. Park for adherence to the protocol. Data will be analyzed during the 
internal pilot, external pilot, and then upon completion of the survey. Interim data analysis after 
both pilots will reduce will be conducted halfway through the trial and results will be reported in 
the annual NIH progress report. Interim data analysis will be conducted halfway through the trial 
and results will be reported in the annual NIH progress report. 
PRIVACY AND CONFIDENTIALITY 
Qualtrics and SSI are extremely careful to protect participant privacy by providing no personally 
identifiable information. All survey materials and study data will be stored digitally on password 
protected computers to which only our study team has access. While researchers can never 
guarantee complete confidentiality of study data, we will take all efforts to prioritize the security 
of data.  You will be assigned a study ID number to help protect your identity and to keep your 
responses confidential.  You can also withdraw from the study at any time.  If the results of this 
research study are published in a medical journal, they will not identify individual patients. Risks 
to subjects have been minimized wherever possible as participants will have the ability to end 
participation at any time and all activities will be directed or overseen by MGH research staff. All 
MGH components have been used successfully in previous trials overseen by Dr. Park. 

 
 
  
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