Screen to Save 2: Rural Cancer Screening Educational Intervention
Phase: NA
Conditions: Cancer, Colorectal Cancer
Sponsor: Dartmouth-Hitchcock Medical Center

 
 
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Cover page 
 
Title  
 
Screen to Save 2: Rural Cancer Screening Educational Intervention 
Clinicaltrials.gov ID NCT04414306 
Unique protocol ID 
D20038 
Document date 
September 25, 2025 
 
 

 
 
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PROTOCOL TITLE: 
Screen to Save 2 
PRINCIPAL INVESTIGATOR: 
 
Judy Rees, BM, BCh, MPH, PhD 
Director, NH State Cancer Registry, 
Associate Director for Community Outreach and Engagement, Dartmouth Cancer Center, 
Associate Professor, Department of Epidemiology, Geisel School of Medicine, 
Dartmouth College 
 
Telephone: 603 646 5492 
Email: Judith.R.Rees@dartmouth.edu 
VERSION NUMBER/DATE: 
 
Version 15:  09/25/2025 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
03/10/2020 
Updated protocol and information sheets for 
consent, per Christina Moord’s requests; 
Updated protocol language on Intervention 
Arm 2 from web-based video to web-based 
module that includes a video; Updated 
protocol’s surveying of Intervention Arm 1 and 
Intervention Arm 2 participants to include 
dummy questions from control arm; Updated 
consent script to complement changes to 
protocol;  Uploaded draft video script 
attachment; Uploaded all surveys; Updated 
recruitment language 
Yes 
2 
06/08/2020 
Removed age language from sample online 
recruitment text (Experimental Arms 2 & 3); 
Revised eligibility screening questions and 
multiple choice response options; revised 
protocol order for online participants 
(Experimental Arm 2 and Control) so that 
potential participants will answer the eligibility 
screening questions before being presented 
with consent process (if eligible) or informed 
that they aren’t eligible; Updated online arm 
No 

 
 
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descriptions to specify use of Qualtrics for 
survey administration where before had 
indicated Qualtrics or RedCap; Updated online 
protocol to indicate that answering pre/post-test 
knowledge questions, colorectal cancer 
behavior intentions questions, and age will be 
required; Updated online protocol to indicate 
that other demographic, personal health, and 
family health questions will either be required 
with a “decline to answer” option or optional; 
Added “decline to answer” option to online 
survey questions now marked as required; 
Updated tailored education information related 
to colorectal cancer risk assessment; adapted 
some survey questions and/or response options 
for enhanced clarity and functionality when 
administered using the online format; updated 
aims and hypotheses to make use of originally 
planned control group as an experimental arm 
related to tobacco and lung cancer screening, 
rather than only a control arm for the colorectal 
cancer screening intervention arms; updated 
lung cancer screening “dummy” questions to 
include additional questions related to lung 
cancer screening and tobacco aims; updated 
electronic gift card information to indicate that 
unclaimed gift cards may be deactivated after 6 
months; updates to data collection and storage 
procedures; uploaded PDFs showing online 
survey content (modified from original NCI 
content and formatting) to be administered to 
participants 
3 
 
Updated Primary Investigator (PI) and related 
contact information on Protocol; updated 
information sheets for informed consent to 
include new PI, eligibility criteria, study 
coordinator name and email and adjusted 
language on contact information and 
compensation for added clarity; updated Study 
Arm 1 Consent script to align with consent 
form updates; revised Arm 2 & 3 Pre/Post 
survey so that eligibility screening takes place 
after consent process; removed Arm 2 & 3 
optional risk assessment and two extra 
Yes 

 
 
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questions related to that risk assessment from 
pre/post survey; adjusted some Tobacco and 
Lung Cancer Screening health behavior 
questions; clarified the webpage for the lung 
cancer screening video; updated linkage to care 
information for use in Pre/Post survey (deleted 
gastroenterology contact info; added questions 
for talking with healthcare provider and health 
insurance/benefits resources for NH and VT 
residents);changed order of Pre/Post survey so 
that post-education questions about cancer 
screening and other health behavior intentions 
come after linkage to community 
resources;modified response language to some 
3- and 6-month participant answers; added a 
recruitment approach; updated recruitment 
language and added potential images for social 
media recruitment; added final colorectal 
cancer screening video for use in Study Arm 2; 
added colorectal cancer screening website text 
4 
9/29/2020 
Updated consent form/information sheet for 
study arms 2 & 3 to match content already 
shown in Pre/Post Qualtrics Survey. 
Yes 
5 
10/12/2020 
Updated information pertaining to 
compensation in situations of incomplete 
participation and withdrawal; updated 
information pertaining to Pre/Post Qualtrics 
survey’s use of timer features and updated 
related settings and text in Qualtrics Pre/Post 
Survey; added a reminder of how to contact a 
study team member by email or phone in the 
event of technical difficulties; added Pre/Post 
questions pertaining to participant’s level of 
engagement with educational content to 
Qualtrics survey; uploaded website used for 
Study Arm 2 colorectal cancer screening 
educational intervention; updated recruitment 
language to indicate possible use of synonyms. 
No 
6 
1/18/2021 
Inclusion of participants who “do not know” if 
or when last received colorectal cancer 
screening in follow-up surveys; Added 
experimental study arm for partnering with 
healthcare systems (e.g. Little Rivers Health 
Care, Inc) to reach participants for online 
Yes 

 
 
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participation (e.g. recruitment via online 
patient portal(s)), which may replace 
experimental arm 1 (in-person engagement); 
updated eligibility information as it pertains to 
study arm 4; added sample recruitment 
language for study arm ; added pre/post survey 
PDF for study arm 4; updated data 
management section to indicate that additional 
study team members will have access to study 
data and add updates pertaining to study arm 4; 
removed Tracy Onega (former PI) at two 
points where updated PI (Anna Tosteson) had 
not been noted in previous modification 
7 
03/23/2021 
Clarified recruitment size intentions; On 
consent/information sheets and Qualtrics 
survey, removed study coordinator phone 
number as method of contact (leaving email as 
method of contact), due to changing phone 
numbers for Dartmouth College employees; in 
protocol added that Study Arm 4 healthcare 
system partner(s) may provide reminder 
message(s) to their patients and/or inform 
patients when the option to enroll in the study 
is no longer available; Removed lung cancer 
screening knowledge questions from Study 
Arm 4 pre/post survey; Added Study Arm 4 
Three-Month Follow-Up Qualtrics PDF 
(adapted version of the survey used for study 
arms 2 and 3). 
Yes 
8 
04/22/2021 
Discontinue accrual into Study Arm 3; Remove 
random assignment to Study Arm 3 from 
Qualtrics survey used for Study Arms 2 and 3 
and some lung cancer screening questions 
associated with that random assignment; access 
to website and video will not be entirely 
restricted to study participants (e.g. DCC may 
allow other healthcare systems to view or use 
the educational webpage and video without 
their users enrolling in a study); Add Judith 
Reese and Regina-Anne Cooper as a study 
team members’ 
No 
9 
08/13/2021 
Inclusion criteria lowered from starting at age 
50 to age 45, to align with new US Preventive 
Service Task Force (USPSTF) colorectal 
Yes 

 
 
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cancer screening guidelines for people with 
average risk and corresponding materials (e.g. 
four Pre/Post knowledge questions, two 3 
month follow-up survey question, web module 
consisting of webpage and video, recruitment 
language, consent forms) updated to reflect age 
45;Noted Regina-Anne Cooper, previously 
approved study team member, as member of 
DDCC Community Outreach and Engagement 
team; removed student study team member 
Haider Ghiasuddin 
10 
09/27/2021 
Switched Anna Tosteson and Judith Rees’s 
roles on study team, making Judith Rees the 
new PI; updated consent forms/information 
sheets and surveys to indicate Judith Rees as 
the PI; added DDCC Community Outreach and 
Engagement team member Heather Carlos to 
research study team; removed research study 
coordinator phone number from 3 and 6 month 
follow-up surveys to correspond with 
telephone number removal approved in 
modification 7 (leaving email as the method by 
which participants can contact the study 
coordinator) 
Yes 
11 
04/12/2022 
Added new team member, Edgard Ngono to 
protocol and removed Katie Lenhoff, who 
resigned from program. 
No 
12 
09/14/2022 
 Removal of some names; replacing with 
title/role only. Rebranding. Correction of age 
range for the study as noted in Revision 9. 
NO 
13 
9/28/2022 
Added details about in-person recruiting at 
community events for web-based module.  See 
page 25. 
 
14 
10/6/2022 
Per the request from the IRB, we have clarified 
that in person  
 
15.  
09/25/2025 
To be in compliance with outcomes reporting 
requirements for clinicaltrials.gov, this revision 
is being submitted to update the protocol to 
reflect the work that was accomplished. Many 
aims and outcome measures had to be curtailed 
because of delays and constraints relating to 
the COVID-19 pandemic. This revision is a 
simplification of the original aims and reflects 
the work that was conducted, removing aims 
 

 
 
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and hypotheses that could not be completed. 
The protocol is greatly simplified, consisting of 
one intervention with pre- and post- surveys. 
 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 8 
2.0 
Objectives* ............................................................................................................ 10 
3.0 
Background* .......................................................................................................... 10 
4.0 
Study Endpoints* ................................................................................................... 11 
5.0 
Study Intervention/Investigational Agent .............................................................. 11 
6.0 
Procedures Involved*............................................................................................. 12 
7.0 
Data and Specimen Banking* ................................................................................ 14 
8.0 
Sharing of Results with Subjects* ......................................................................... 14 
9.0 
Study Timelines* ................................................................................................... 15 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 15 
11.0 Vulnerable Populations* ........................................................................................ 16 
12.0 Local Number of Subjects ..................................................................................... 17 
13.0 Recruitment Methods ............................................................................................. 17 
14.0 Withdrawal of Subjects* ........................................................................................ 18 
15.0 Risks to Subjects* .................................................................................................. 19 
16.0 Potential Benefits to Subjects* .............................................................................. 20 
17.0 Data Management* and Confidentiality ................................................................ 20 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 22 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 22 
20.0 Compensation for Research-Related Injury ........................................................... 23 
21.0 Economic Burden to Subjects ................................................................................ 23 
22.0 Consent Process ..................................................................................................... 23 
23.0 Process to Document Consent in Writing .............................................................. 25 
24.0 Setting .................................................................................................................... 25 
25.0 Resources Available............................................................................................... 26 
26.0 Multi-Site Research* ............................................................................................. 27 
 
 
 

 
 
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1.0 
Study Summary 
 
Study Title 
Screen to Save 2 
Study Design 
Prospective Observational/Cohort Study 
Pre-/Post-/Follow-up (via surveys) 
Primary Objective 
Implement and evaluate Screen to Save (S2S) outreach and educational 
activities to improve knowledge of colorectal cancer screening methods, to 
increase intent to get screened for colorectal cancer, and connect screening 
services to 45-74 year-old residents living in NH and VT—focusing on the 
most rural counties (RUCC 7—9).  
Research 
Intervention(s)  
Education about colorectal cancer screening via online video and written 
education materials. 
Study Population 
The target population is adults aged 45-74 years old who reside in rural New 
Hampshire or Vermont; “rural” = Rural Urban Continuum Codes (RUCC) 
7—9 counties (Coos and Sullivan County, NH; Caledonia, Windsor, 
Windham, Orange, Orleans, Lamoille, and Essex County, VT) 
 
To be eligible to enroll in the study, people must meet the following 
eligibility criteria: 
-Be a resident of one of the RUCC 7—9 counties in NH and VT and 
-Be 45-74 years-old at the time of enrollment 
except in the instance of recruitment via Experimental Arm 4 (e.g. 
recruitment through Little Rivers Health Care, Inc.), in which case 
individuals may enroll in the study if age 45-74 and if residing in states or 
counties other than those specified above, if agreed upon by the research 
study team and partner institution 
Sample Size 
Our target recruitment size is 196-225 participants completing the pre/post 
survey in each of two arms (Arms 2 and 4). Recruitment into study arm 3 
will be discontinued in April 2021 due to changes in lung cancer screening 
guidelines affecting the educational intervention content, resulting in fewer 
than 196 participants completing that arm. Projecting that up to 50% of 
people who consent may not complete the pre/post survey, we project that 
up to 950 people may be enrolled total. 
Study Duration for 
individual 
participants 
Up to 7.5 months 
Study Specific 
Abbreviations/ 
Definitions  
S2S= Screen to Save 
CRC= Colorectal Cancer 
LCS= Lung Cancer Screening 
NCI= National Cancer Institute 
CRCHD=Center to Reduce Cancer Health Disparities (a division of the 
National Cancer Institute) 
NON= National Outreach Network (an effort of CRCHD) 
CHE= Community Health Educator 

 
 
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COE= Community Outreach and Education (a focus of the Dartmouth 
Cancer Center) 
DH = Dartmouth Health 
DCC= Dartmouth Cancer Center 
RUCC= Rural-Urban Continuum Codes (a U.S. Department of Agriculture 
schema for defining communities as rural/urban) 
 
 

 
 
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2.0 
Objectives* 
2.1 The primary purpose of this project is to: (1) contribute to a nation-wide 
initiative to educate the public about colorectal cancer risk factors and colorectal 
cancer screening, (2) evaluate the effectiveness of education about colorectal 
cancer in changing knowledge, behavioral intentions, and behaviors related to 
colorectal cancer screening and prevention.  
 
Aim 1: Implement and evaluate Screen to Save (S2S) outreach and educational 
activities to improve knowledge of colorectal cancer and colorectal cancer 
screening methods, to increase intent to get screened for colorectal cancer, and 
connect screening services to 45-74 year-old residents living in NH and VT—
focusing on the most rural counties (RUCC 7—9 designations- see figure 1). 
The study utilizes web-based module to conduct targeted outreach about 
colorectal cancer screening using the S2S framework and materials and refer them 
to locally-available screenings, healthcare provider system, and/or healthcare 
coverage systems. 
 
2.2 Hypotheses:  
 
Online/video outreach about CRC will be effective in: a) increasing adults’ 
knowledge of CRC risk factors, CRC screening recommendations and options, 
and CRC prevention; b) increasing unscreened adults’ intent to get screened for 
CRC 
 
3.0 
Background* 
3.1 Colorectal cancer (CRC) is the fourth most common type of cancer in men 
and women in the U.S. and is the second leading cause of death from cancer. The 
U.S. Preventive Services Task Force recommends that all adults 45-74 years old 
get screened for colorectal cancer. Yet, some populations do not get screened as 
often as they should. In the Dartmouth Cancer Center’s (DCC) catchment area of 
Vermont and New Hampshire, these populations include, but are not limited to, 
the uninsured/underinsured, low socioeconomic status individuals, racial/ethnic 
minorities, and people living in certain geographic areas—including rural 
communities.  
 
3.2. In 2017, the National Cancer Institute’s (NCI) Center to Reduce Cancer 
Health Disparities (CRCHD) launched a nationwide CRC initiative called Screen 
to Save. The goal is to increase CRC screening rates among 45-75 year old 
adults—especially from racially and ethnically diverse populations and people 
living in rural areas. The initiative initially involved about 49 sites—including 
DCC—that received NCI/CRCHD funding to support Community Health 
Educators (CHEs). CHEs were expected to utilize a set of key messages about 
CRC risk factors, screening, and prevention to educate the public via educational 

 
 
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outreach events in settings such as health fairs, festivals, and other community 
settings. Data was collected to assess participants’ knowledge change from pre- to 
post- intervention, and NCI’s preliminary national analyses show positive 
changes. 
 
In New Hampshire, the 30-day prevalence of tobacco use among adults is 
approximately 15.7%. In Vermont, it is about 15.8%. Tobacco use is a risk factor 
for more than a dozen cancers and chronic diseases, including colorectal cancer 
and lung cancer. 
 
 
3.3 In 2019, DCC and about 23 other cancer centers received a new award from 
NCI/CRCHD to re-launch Screen to Save. The basic framework for the initiative 
is similar to the original framework, with the following key changes: 
-DCC will more specifically prioritize rural populations in NH and VT, 
-DCC will need to collect additional data elements from the participants, 
including follow-up data to assess whether the intervention is effective in 
increasing uptake of colorectal cancer screening; data will look at knowledge, 
behavioral intentions, and behavior change as a result of the education 
-DCC will implement the initiative in an online module  
-DCC will provide participants with information about local CRC screening 
services available and, where feasible, will coordinate with local screening service 
providers (though actual rendering of screening services is outside of the scope of 
this project). 
 
This effort will contribute to a national evaluation of Screen to Save and will help 
NCI/CRCHD with future planning of national initiatives. It will also influence 
DCC’s Community Outreach and Engagement program’s planning for future 
interventions to reach the rural populations of New Hampshire and Vermont. 
Additionally, it will add to the literature base regarding group education 
interventions for colorectal cancer screening, which currently is rated as having 
‘insufficient evidence’ by The Guide to Community Preventive Services. 
 
 
4.0 
Study Endpoints* 
4.1. Knowledge, attitudes, and behavioral intentions related to colorectal cancer 
risk factors, screening, and prevention (assessed via pre/post/follow-up surveys) 
 
4.2 Uptake of colorectal cancer screening (behavior change) as a result of the 
outreach models (assessed via follow-up survey) 
 
5.0 
Study Intervention 

 
 
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5.1 DCC’s Community Outreach and Engagement Team will implement Screen 
to Save in an online format. The education will be based on a set of key messages 
that cover information about colorectal cancer, including risk factors, prevention, 
screening recommendations, and screening options (see attached PowerPoint 
presentation with key messages Screen to Save: Colorectal Cancer 
Basics.120916). NCI/CRCHD’s key messages will be tailored to the local context 
of NH and VT, including information about local options for getting screened for 
colorectal cancer (see draft outline of talking points- attached). 
 
Web-based module- Participants who access the study will be directed to watch a 
video/review online information that includes the key messages about colorectal 
cancer, risk factors, prevention, screening recommendations, and screening 
options. 
 
 
6.0 
Procedures Involved* 
6.1—6.5. This study uses a pre/post/follow-up design utilizing surveys. 
See below for more information about the surveys. 
 
Our CHE will use a web-based educational-format with video and accompanying 
educational information shared through social media outreach to conduct a similar 
intervention as described in experimental arm 1. Recruitment will be facilitated 
through paid advertisements in Facebook, which will be targeted to 4574 year-old 
residents in RUCC, 7, 8, and 9 counties throughout VT and NH. The 
advertisements will ask the prospective participants to click to ‘learn more’ and 
will be directed to a Qualtrics survey, which will lead them through: 
 
a- A consenting process utilizing the research information sheet (see enclosed 
information sheet and waiver of signature). 
b- Screening for eligibility- Prospective participants will be asked a) to select the 
age group that they are part of; b) Which state they live in; and c) Which 
county they live in. Participants indicating that they are between the ages of 
45—74 years old and live in one of the nine RUCC 7—9 counties in NH and 
VT will be eligible. Prospective participants will be required to answer the 
eligibility screening questions in order to advance to the remainder of the 
study content: the rest of the survey and educational intervention. Participants 
who do not meet eligibility criteria will be informed that they do not meet the 
eligibility criteria. 
c- A pre-test survey - Answering pre-test and post-test knowledge questions 
about colorectal cancer and screening and colorectal cancer behavior 
intentions questions will be required in order for participants to progress 
through the study, as will answering a question about the participant’s age in 
years. Answering all other demographic questions and questions about 

 
 
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personal or family health experiences will either be required with a “decline to 
answer” option or optional. Some online questions (i.e. lung cancer and 
colorectal cancer knowledge questions) will be presented in a random order 
using Qualtrics features for randomization. 
d- Educational intervention (described in section 5) based on NCI/CRCHD’s key 
messages (see CRC Website Link document for webpage) uses a web-based 
educational-format containing a video (see S2S CRC Video attachment) and 
accompanying educational information (not visible to the general public) with 
additional information on colorectal cancer and colorectal cancer screening 
(See CRC Website Text attachment). Both the video and the website content 
are based on the NCI talking points and related, relevant information from 
content area experts. We will no longer use a timer setting in Qualtrics that 
prevents participants from moving forward to the next step in the online 
survey until a defined amount of time has passed to align with the minimum 
needed time to watch the video and view the website (e.g. 5 minutes). We 
may, however, continue to use the timer functionality allowing us to measure 
how much time participants spend on specific portion(s) of the online survey 
and educational intervention and in totality.  
e- Question(s) asking participants how much of the online educational content 
they watched and/or read (see Qualtrics Pre/Post Survey) 
f- A post-test survey as described earlier regarding colorectal cancer screening 
knowledge (see attachment) 
 
 
 
After receiving the web-based education, participants will be asked about whether 
they have a healthcare provider to speak with about colorectal cancer screening and 
whether they currently have insurance. Participants who answer “yes” to the first 
question will be encouraged to talk with their healthcare provider about their individual 
cancer risk and cancer screening options and can download a document of CDC 
developed questions for talking to a healthcare provider about colorectal cancer. 
Participants answering “yes” to the second question (having insurance) will be informed 
that if they do not have an established healthcare provider they can consider contacting 
their insurance provider to find a provider in their network. Participants who do not 
indicate that they have a healthcare provider to speak with by answering “no” or “decline 
to answer” will be informed that talking with a healthcare provider can be useful and will 
be provided with a downloadable list of some healthcare systems that provide primary 
care services in the counties we are targeting for our interventions or nearby. This list will 
include a statement indicating that other healthcare providers may be available in or near 
their communities so that participants wishing to explore other options are reminded of 
their autonomy to research on their own. This document will also include the same CDC 
adapted questions for talking to a healthcare provider about colorectal cancer provided to 
those who do report having a healthcare provider. Participants who do not indicate that 
they have insurance by answering the second question with a “no” or “decline to answer” 
will be informed that talking with a healthcare provider can be useful and receive 
information on local agencies or organizations in their state (New Hampshire or 

 
 
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Vermont) that may be of assistance in understanding and/or obtaining healthcare 
coverage. The study team will make updates to these linkage to care documents (see 
attached: guide for talking with healthcare provider; local healthcare systems providing 
primary care; local systems that provide help understanding or obtaining healthcare 
benefits) should new resources appropriate for the target audience be identified and/or 
entities discontinue or alter services and/or contact information or eligibility for any of 
the listed services change over the course of the project in the interest of providing up-to-
date and relevant linkage to care.      
 
See CRC Linkage to Care documents which will also be made available to all 
participants. 
 
g- A post-test survey as described earlier addressing colorectal cancer screening 
and related behavior change intentions (see attachment) 
h- Collection of contact information (name, email, phone number, address) and 
assignment of unique numeric identifiers for study participants.  
i- After participants complete the first round of online activities as described 
above, a study team member will assign all participants a unique six-digit 
identifier to each participant, which will be used to track participants’ data. 
Participants invited to participate in follow up surveys (three months; six 
months) will either be provided with a shortened (3 or 4-digit) version of this 
identifier and the month of their original participation to use in lieu of 
submitting their names or other personal contact information with those 
follow-up surveys or features within Qualtrics will used to automatically 
transfer this information onto the follow-up surveys for necessary tracking 
purposes. Setting up this automated system to minimize the risk of participant 
data-entry error does mean that within Qualtrics there would be a way to trace 
data collected from the follow-up surveys to the first survey in which 
participant contact information (e.g. name, address, phone number) is 
collected. Only members of the study team would have access to these 
Qualtrics files. 
j- Administration of participant payments (e-gift cards) 
k- A follow-up survey administered at three-months post intervention (and six-
months post intervention, as needed). 
l- E-mailing de-identified pre, post, and follow-up survey data to NCI/CRCHD 
and/or its contractor for data entry, quality control, and national aggregation 
m- Local analysis of data to determine effect of study objectives 
 
 
 
7.0 
Data and Specimen Banking* 
N/A- This study does not involve data or specimen banking. 
 

 
 
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8.0 
Sharing of Results with Subjects* 
8.1 Results of pre-/post-/follow-up survey scores/results will not be shared 
with individual study participants. 
As described earlier, de-identified study data will be shared with 
CRCHD/its contractor for aggregation and evaluation. 
At the conclusion of the study, we plan to develop a community report to 
share with relevant stakeholders (e.g., DCC Community Advisory Board, 
colorectal cancer screening professionals, primary care providers, cancer 
control professionals) to learn about the study; all data in this report will 
be de-identified and aggregated. We will also seek opportunities to 
disseminate the results through academic channels, such as conferences 
and publications. 
 
9.0 
Study Timelines* 
 
9.1 Participants will conclude their participation within 7.5 months from 
enrollment. This timeline allows for a multi-week window for completion of the 
six-month follow-up surveys. 
 
We anticipate enrolling all study participants within two years of study activation. 
 
10.0 Subject Population* 
10.1. The target population is adults aged 45-74 years old who reside in rural New 
Hampshire or Vermont; “rural” = RUCC 7—9 counties (Coos and Sullivan 
County, NH; Caledonia, Windsor, Windham, Orange, Orleans, Lamoille, and 
Essex County, VT). 
 
10.2. To be eligible to enroll in the study, people must meet the following 
eligibility criteria: 
-Be a resident of one of the RUCC 7—9 counties in NH and VT and 
-Be 45-74 years-old at the time of enrollment 
We have three eligibility screening questions that will be asked of all study 
participants: 
1) What is your age? (in years) 
2) What state do you live in? 
3) What county do you live in? 
 
Participants will be social media users. Social media advertising features will be 
used to target social media users in the appropriate age range and geographic 
locations of interest. 
 

 
 
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10.3 Regarding adults unable to consent: For online participants, there are 
several steps involved in accessing our study which, we feel, will 
safeguard adults unable to consent from participating in the study; for 
example, in order to access the study online, that will require having a 
social media account, navigating away from the social media account to 
our survey site, reading the information sheet, and proceeding forward to 
the survey. 
Regarding individuals who are not yet adults: All participants will be 
screened to self-disclose whether they are in the study age range (45-74 
years old) at the time of enrollment; hence, no minors will be enrolled. 
Further, recruitment for the web/video arms (intervention and control) will 
use Facebook’s marketing features to target account holders in the age 
range of interest to the study. 
Pregnant women: Given the 45-74 age group targeted by this study, it is 
possible but unlikely that pregnant women will be participating. Any 
inclusion of pregnant women will be strictly incidental and will not 
present any added risk should they choose to participate. We will not be 
asking any questions pertaining to pregnancy, and we will not specifically 
be targeting pregnant women. Regardless of whether or not a 45-74 year-
old person is pregnant, receiving age-appropriate cancer screening 
education and discussing screening options with a medical provider can be 
beneficial, which is exactly what our study aims to provide and encourage. 
As such, we will not exclude pregnant women from participating. 
Prisoners: We will not be initiating any research in institutionalized 
settings nor will we explicitly target prisoners. No questions, including 
screening questions, will be specifically asked about a person’s 
incarceration status. Any inclusion of prisoners will be strictly incidental 
and will not present any added risk should they choose to participate.  
For in-person events, anyone will be able to learn about colorectal cancer 
screening by participating in the education, as the events will be open to 
more than just study participants.  
 
11.0 Vulnerable Populations* 
11.1 It is likely that some participants may be elderly. It is also possible that some 
participants will be from an economically disadvantaged background, especially if 
partnering with a Federally Qualified Health Center such as Little Rivers, 
Healthcare, Inc. We feel that the payment amounts we plan to provide are 
appropriate given the participants’ time involved and are not excessive or 
coercive.  

 
 
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As stated in Section 10, our study is not targeting any of the following vulnerable 
populations: pregnant women, neonates/non-viable neonates, prisoners, people 
who have not attained legal age to consent, or cognitively-impaired adults. 
 
12.0 Local Number of Subjects 
Our target recruitment size is 196-225 people completing the pre/post survey. 
 
13.0 Recruitment Methods 
13.1—13.4  
 
For online recruiting, we will purchase advertisements on Facebook, which will be 
targeted to people who meet the age and geographic eligibility criteria for study 
participation. We will rely of Facebook’s algorithms to direct our recruitment messages 
to individuals in the appropriate age range and geographies. Advertisements will use 
verbiage such as: 
 
“Researchers are looking for adults ages 45-74 to participate in a study about cancer 
screening. Residents of nine rural counties can enroll. Your voluntary and confidential 
participation will include reading information, watching a video, and answering survey 
questions. You will receive a gift card for your time. Click to learn more about 
participating in this research study by the Dartmouth- Cancer Center. “ 
 
 
See Recruitment Messaging document attached, and see attached Sample Images 
that may accompany the online recruitment text. 
 
Additionally, we may post similar advertisements on other social media platforms such as 
Instagram and we may post the study announcement on the DCC and/or Dartmouth 
Health Facebook pages. Announcements posted on the DCC and/or Dartmouth Health 
Facebook pages would be visible to viewers of any age and geography, as the 
geotargeting features of Facebook Advertising would not apply, but only those people 
who meet the eligibility criteria based on their responses to the screening questions would 
be enrolled. 
 
 
In addition, we have partnered with the study team administering Study00031200 (DHH 
IRB) / D20039 (OnCore): Education about Health and Cancer Study to assist with 
identifying prospective participants for our study. That study educates online adults (from 
the same nine New Hampshire and Vermont counties as we are targeting in this study) 
about cancer research studies and clinical trials, and that study is pre-screening their 
study participants for possible eligibility for other studies (such as ours). As part of their 
participation in that study, participants will be asked some questions to see if they may be 

 
 
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eligible to enroll in any active research studies. Screen to Save 2 will be one of the 
studies to which participants can be linked. Participants indicating that they are 45-74 
years old will be provided with a brief description of the Screen to Save 2 study and 
asked for permission to share their contact information with the Screen to Save 2 study 
team. (See attached Recruitment Language document.) Those who give permission will 
have their contact information passed on to a designated Screen to Save 2 study team 
member, who will send an email to the STUDY00031200/D20039 participant about the 
Screen to Save 2 study. That email will contain a link to access the online Screen to Save 
2 study. The email will also contain contact information for a Screen to Save 2 study 
team member, should the recipient have any questions or concerns. (See Sample Email 
for Participants Referred from Study D20039).  
 
13.5 Participants will receive up to a total of $30 in gift cards (e.g. to Amazon.com). 
Participants will receive a $15 gift card for completing the pre-test, in-person or online 
learning, post-test, screening assessment questions (for online participants), and 
providing their contact information. Participants asked to complete the 3-month follow-
up survey will receive an additional $10 gift card for their time completing that survey. 
Participants asked to complete the 6-month follow-up survey will receive the final $5 gift 
card for their time completing that survey.  
 
The first gift card will be distributed to in-person participants in-person on the day of the 
event; the second and third gift cards will be sent by email, unless a participant does not 
have an email address or requests that the gift card be sent via regular mail; we will aim 
to distribute these gift cards/codes within 2 weeks of receiving completed surveys. For 
online participants, all gift cards will be distributed via email. Gift cards will be sent 
within 2 weeks of the study team receiving each completed survey. 
 
Participants will have 6 calendar months to claim their electronic gift cards from the time 
that they are emailed to participants. Electronic gift cards that are not claimed after 6 
months may be deactivated. 
 
 
14.0 Withdrawal of Subjects* 
14.1 Study subjects will be withdrawn from the study if they do not complete the pre-test, 
educational intervention, post-test, and provision of contact information—as we need the 
full set of information in order to evaluate our intervention. Additionally, as noted in 
Section 6, our study team will reach out to participants up to four times by email/phone 
(total) and up to one paper mailing for the three-month follow up survey and for the six-
month follow-up survey. If no response is garnered, efforts to reach participants for the 
survey will be discontinued. Participants who do not respond to any of these efforts 
within 1.5 months of the first effort being made for that survey will be withdrawn from 
the study. Participants who do not complete the three-month survey will be disqualified 
from continuing on to the six-month follow-up survey.  
 

 
 
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14.2  
 
Any participant can discontinue participation at any time by closing the window 
on their device’s screen that contains our video/module or survey content. 
Because participant contact information will be collected only after the post-test is 
administered, individuals who do not complete the pre-test, video/web education, 
and post-test will not be eligible to receive a $15 gift card, except in instances 
where individuals report to the study team that they have enrolled as participants 
but were unable to complete the pre/post survey, despite their eligibility and intent 
to do so, for reasons attributable to an implementation error or substantive 
inconvenience in survey delivery (e.g. participant reports being unable to progress 
to the end of the survey). In this case, if the source of the problem cannot be 
remedied conveniently to facilitate completion of the survey, the $15 gift card 
will still be offered, so long as the information reported to the study team appears 
credible, given the study team’s knowledge of the eligibility criteria, recruitment 
strategies, study content, and technology platforms. In this case, a designated 
study team member will still need to collect the individual’s name and contact 
information so that the gift card can be distributed and proper financial records 
maintained; however, subsequent participation in the three and six month follow-
up surveys will not be allowed.  Individuals who report inability to complete the 
survey, whose reported participation began on or after October 8, 2020, will be 
informed of the opportunity to receive this compensation in accordance with the 
standards stated above. 
Any participant who does not complete the pre-test, video/web education, and 
post-survey will not be contacted for 3- or 6-month follow-up. 
 
Participants who do not respond to initial communications for three- and six-month 
follow-up surveys will be informed, at a minimum, in the final communication effort, of 
the deadline by which they must respond and complete the survey in order to remain in 
the study. Participants in telephone-based three- or six-month follow-up surveys who 
express a desire to withdraw from the study partially through the survey process will be 
provided a gift-card, but not contacted for six-month follow-up. Participants in the online 
three- and six-month surveys who withdraw from the study will only receive a gift card if 
they have submitted the specified online survey to the study team, again with the 
exception that participants will be compensated for the specified survey in the event that 
they are eligible and intend to complete the study but report to the study team that they 
are unable to do so for reasons attributable to an implementation error or substantive 
inconvenience in survey delivery, as described above for the pre/post survey. 
 
15.0 Risks to Subjects* 

 
 
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15.1 Because this activity is primarily educational and seeking to increase knowledge and 
positive behavior change in relation to colorectal cancer and lung cancer, risks are 
minimal. However, some participants with a family history of cancer or who have had 
negative experiences with past cancer screenings may have some discomfort with the 
topic of colorectal cancer or lung cancer and may be distressed by the nature of the 
survey questions. Additionally, as with the collection of any identifiable information, 
there is minimal risk that confidentiality could be breached. However, we will have 
several safeguards in place, as described in Section 17 and in the attached document 
entitled Screen to Save Data Collection Storage and Security. 
 
 
Because the risks are unlikely and minimal, we feel that they’re reasonable in relation to 
the knowledge that participants will gain, as well as the knowledge that NCI/CRCHD and 
DCC will gain. 
 
15.2-15.4. N/A 
 
16.0 Potential Benefits to Subjects* 
16.1 We do not expect a direct benefit to participants. However, participants may learn 
new information about cancer screening. Participants who have never discussed cancer 
screening with a healthcare professional, participants who have never pursued cancer 
screening, and participants who do not have personal or family histories of cancer may be 
more likely to find that the information is new to them. 
 
By attending our in-person education events people may also have the opportunity to 
speak with local healthcare providers about cancer screening or other topics, regardless of 
whether or not they enroll in our study. 
 
As feasible, participants will receive tailored educational information based on their 
individual responses to the screening option assessment and pre-test, as well as 
information about locally-available screening services. 
    
17.0 Data Management* and Confidentiality 
17.1. Our sample size is based on a two-tailed test with 0.05 significance level, 
and 80% power to detect an effect size of 0.2 (20% difference in the before/after 
difference-in-difference estimates), with a standard deviation of 1.0. We will 
conduct various statistical tests on the data to determine whether participants 
experienced changes in knowledge, attitudes, behavioral intentions, and behavior 
as a result of the intervention, and changes will be look at across groups.  
17.2. To ensure confidentiality of data, we will have several safeguards in place: 
• Training: All research team members with access to study data will be 
trained on all procedures related to data management under this protocol. 
• Access restrictions: Access to electronic research materials/data will be 
limited to those on the research team. This will include only granting 
electronic access to Qualtrics and One Drive/Sharepoint to study team 

 
 
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members, these sites/applications also require passwords to access. All 
laptops/computers being used will also be encrypted and password-
protected. Access to physical research materials/data will also be limited 
by being stored in locked filing cabinets at DHMC. 
Unique identifiers: We will assign a unique identifier to the study information 
using the numbers provided by NCI/CRCHD/its contractor. For study arm 1 
participants, we will link the pre-, post-, and follow-up surveys using the unique 
identifiers/bar codes. Contact information requested from participants for 
purposes of follow-up and gift card distribution will be obtained, managed, and 
stored separately from the other study data. For study arm 2 and 3 participants, 
the pre- and post- survey data will be collected and stored in the same Qualtrics 
survey that solicits participant contact information for follow-up and gift card 
distribution. Only study team members will have access to this file, which has the 
access restrictions noted above. Once this data is collected via Qualtrics, a study 
team member will assign a unique identifier to each participant. After initial 
review of the online data as discussed in section 17.3 for data quality control, 
subsequent data review and analysis will be performed in a newly created 
electronic file where participant name and contact information is replaced with 
the participant’s unique, assigned identifier. A separate document will be created 
consisting of participant name and contact information so that the Qualtrics 
survey containing participants’ other responses does not need to be referenced for 
participant follow-up and electronic gift card dissemination. Participants asked to 
participate in follow-up surveys will either be emailed a shortened version of that 
unique identifier and the month of their original participation as part of the 
request for their participation in the follow-up and asked to manually enter those 
two pieces of data into the online follow-up surveys or the study team will use the 
features within Qualtrics to transfer the participant ID number and month of initial 
participation to the follow-up surveys so that it automatically populates to avoid 
the risk of participant error in transferring the code and month to the follow-up 
surveys. If these Qualtrics features are used to transfer the participant code and 
month of enrollment information, within Qualtrics there will be a way to trace the 
data collected at follow-up back to the initial survey in which participants provide 
their names and contact information (e.g. phone, email, address); however, only 
study team members will have access to these Qualtrics files. For all study 
participants, the key linking participants’ identities and contact information to 
their unique identifier codes will be stores separately from other data. 
 
17.3. Data quality control: 
The DCC research team will review data collected from the first 5-10 respondents 
with each Facebook advertisement wave that is launched to check for possible 
problems such as errors in computer display to participants, errors in skip logic, 
and robotic responses. If the audit reveals a potential data quality issue, the 
research team will review additional data to determine how widespread the issue 

 
 
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is and will work with the appropriate D-H and DCC colleagues (e.g. tech support) 
and NCI/CRCHD to address the issues, as needed. 
 
 
As with any study that collects information about health, such as a person’s 
family health history, it is important to secure this information. As stated below, 
multiple safeguards have been put in place to minimize the risk of possible data 
disclosures. We do not plan to obtain a certificate of confidentiality. 
 
17.4. Original paper research forms/data will be kept in a locked filing cabinet at 
DHMC for five years. All electronic files will be stored on password-protected, 
encrypted computers that are property of the Dartmouth Cancer Center. Electronic 
data will also be stored in password-protected sites/applications supported by 
Dartmouth/DH, such as Qualtrics and Sharepoint/One Drive; access will only be 
granted to official study team members. All files, paper and electronic, at DHMC 
will be destroyed six years after the study is completed. 
 
De-identified survey copies/survey data from the experimental arms will be 
emailed/mailed to NCI/CRCHD/its contractor for data processing on a quarterly 
basis. Data collected from participants to be shared include pre-test, post-test, and 
follow-up survey responses (all de-identified, using unique identifier) from our 
experimental arms (not control arm). We will also provide NCI/CRCHD/its 
contractor with general information about the in-person events (e.g., dates, 
locations, number of attendees), about the social media ad reach/metrics, and, as 
needed, cost. The study coordinators will be responsible for sharing the data with 
NCI/CRCHD/its contractor. Please see the attached document from NCI/CRCHD 
entitled Screen to Save Data Collection Storage and Security for additional 
information. 
 
 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
N/A- This study involves only minimal risks.  
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
 
Contact information requested from participants for purposes of follow-up and 
gift card distribution will be obtained at the time of the first (pre/post) survey in 
Qualtrics. When the data are converted to a data file for analysis, a study team 
member will assign and add a six-digit NCI code to each participant’s responses 
or a shortened version of that code and upon doing so that study team member 
will remove the participant’s name and contact information from that data file 
used for analysis. Separate documents will be created containing the participant 
name, contact information, and code for follow-up and gift card distribution. As 
noted in section 17 of this protocol, within the online Qualtrics platform there 
may be a way to link the three and six-month follow-up surveys back to 

 
 
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participants’ first surveys where their names and contact information are 
provided; however, three- and six-month files used for data analysis will not 
contain participants’ names or contact information, only their assigned NCI 
numbers or shorted versions of those numbers and the month of their original 
participation. Only study team members will have access to the Qualtrics online 
platform and the data analysis files produced from Qualtrics via the password 
protected systems and encrypted devices as noted in section 17.2 of this protocol.   
 
The default method for completing the follow-up survey will be through the 
internet at a time/place of the participants’ choosing. Should any participants 
choose to complete the survey by phone with a CITI trained research team 
member, the research team member will take steps to ensure that others are not 
able to overhear the phone call (e.g., closing door, not using speaker phone). 
19.3 Only study team members will have access to forms containing 
identifiable information. This information will only be accessed for 
relevant study purposes such as  gift card distribution, follow-up survey 
administration, and checking online survey data collected for authenticity 
to protect against including automated online responses (bots) and 
duplicate participation. 
 
20.0 Compensation for Research-Related Injury 
This study involves no more than minimal risk to subjects. 
 
21.0 Economic Burden to Subjects 
Study participants will not be subject to any costs for participating in the 
study/educational interventions.  
Should our intervention be effective in encouraging them to get screened 
for colorectal cancer, all costs associated with screening and/or visiting a 
healthcare professional to discuss screening will be the participants’ 
responsibility.  
 
22.0 Consent Process 
Once the prospective participant clicks the Facebook ad to learn more about the 
study and answers the initial eligibility screening questions, the prospective 
participant will be presented with an information sheet (attached) and asked to 
read it before proceeding. As part of the information sheet, participants will be 
provided with contact information for the study team should they have any 
questions before proceeding. Once they initial and click the arrow button to 

 
 
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provide implicit consent to participate in the study, they will be asked to complete 
the following components (in the same session): 
• eligibility screening questions (participants not meeting eligibility age and 
geographic criteria will have their study participation end at that point; 
eligible participants will be able to advance to the next sections),  
• pre-test with added tobacco and lung cancer screening questions 
• educational module, 
• tailored education/information about talking with a healthcare provider, 
local healthcare providers, and local insurance/benefits resources 
• Post-test questions pertaining to cancer screening/prevention—including 
lung cancer screening—and other health behavior intentions, 
• study participant providing name and contact information, and 
• information about e-gift card distribution. 
 
 
We will be following procedures outlined in HRP-090, with a few exceptions: 
• Section 3 of HRP-090:  
o 3.8- If the prospective participant expresses interest in 
participating, based on clicking on the social media ad, the 
participant will then be invited to review an information sheet and 
continue into the study, if they are interested. They will also be 
provided with study team contact information, should they have 
questions before consenting to participate. 
• Section 5 of HRP-090: 
o 5.3- An information sheet will be presented to the participants. See 
enclosed information sheet. 
o 5.4 and 5.5- Participants will be provided with study team contact 
information, should they have questions or want to talk with 
family/friends before consenting to participate. 
o 5.7- Participants will be completing an implicit consent process, 
which is explained in the information sheet. We will have 
participants read and confirm the following: 
Please confirm that you have done each of the following (by 
checking each box): 
_ I have read the above information about this study. 
_ I understand that I can contact the study team using the 
contact information provided, should I have any questions about 
the study. 
_ I understand that participating in this research study is 
completely voluntarily and that I can stop participating at any time. 
 
Clicking the button at the bottom of the screen to continue 
forward indicates your consent to participate in this study.  
 

 
 
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Non-English Speaking Subjects: At this time, we will not enroll non-English 
speaking subjects.  
 
Subjects who are not yet adults: We will not enroll any subjects who are 
not yet adults. Our age requirements are 45-74 years old at the time of 
enrollment. Anyone outside of this age range will be screened-out of 
participating. 
 
Adults unable to consent and cognitively-impaired adults: We do not 
intend to enroll adults who are unable to consent or cognitively-impaired 
adults. For online participants, there are several steps involved in 
accessing our study which, we feel, will safeguard against these 
populations participating in the study; for example, in order to access the 
study online, that will require having a social media account, navigating 
away from the social media account to our survey site, reading the 
information sheet, and proceeding forward to the survey. 
 
23.0 Process to Document Consent in Writing 
23.1. We will not be following SOP HRP-091, as we are requesting a 
documentation waiver. See enclosed waiver checklist. 
 
23.2 and 23.3. Because this study involves no more than minimal risk, we are 
requesting that the documentation of signature be waived.  
 
 
In place of obtaining written consent, we plan to provide an information sheet 
about the study to all participants whose eligibility screening responses indicate 
their eligibility to participate (see attachment). This information sheet includes the 
required HIPAA authorization content, for which we will not seek a signature due 
to the electronic nature of the intervention. 
 
 
24.0 Setting 
 
24.1 Study procedures will take place on-line:  
Recruitment will take place through social media (e.g., Facebook), and the 
surveys/intervention will be accessed online through Qualtrics. 
Follow-up surveys for this arm will also be administered online (when 
possible) and by phone (when needed). Study team members conducting 
follow-up calls to and three-month and six-month surveys with 

 
 
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participants will do so from a private room at the Dartmouth Cancer 
Center at Dartmouth Health in Lebanon, NH.  
DCC does have a Community Advisory Board that is administered by a 
study member. Board members include cancer survivors and caregivers, 
community members, public health researchers, healthcare organizations, 
and non-profit representatives. We may consult with the Community 
Advisory Board or a subset of its members regarding: 
-Content of video and educational module and/or review of video 
-Review of aggregate, de-identified results 
-Next steps after this study is complete; steps regarding 
sustainability of video/module and/or in-person events 
 
25.0 Resources Available 
25.1 Our study team has CITI-trained staff members who can be engaged 
for completing study procedures including, administering pre-tests and 
post-tests, providing education, and distributing gift cards.  The study 
coordinator will be dedicated at about 0.5 FTE to the study and will serve 
as the primary study coordinator Additional CITI-trained staff or 
volunteers can be secured, if needed, in which case an IRB modification 
will be submitted. 
 
Prior to conducting the first in-person event or launching the online study 
arms, team members will convene to review the protocol, discuss the 
logistics of implementation, and address team member questions. Study 
progress and update meetings will be scheduled on an as-needed basis for 
this purpose, and any new study team members will be trained before 
being allowed to conduct study procedures. 
 
Study planning and procedures will mostly take place in office space in 
the Rubin 8 building at DH (although in-person events will take place 
throughout New Hampshire and Vermont). No special facilities/equipment 
is needed for the conduct of this study, aside from laptops and storage to 
secure study materials. 
 
Additional resources available to our team include shared resources 
available through DCC and resources through Dartmouth/DH, including: 
-Qualtrics support 
-Data management and biostatistical analysis support 

 
 
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-Geo-spatial analysis support to identify population counts and 
rural communities 
-Social media consultation support 
 
Additionally, our team has funding and in-kind support from: 
-National Cancer Institute 
-Dartmouth Cancer Center (institutional/philanthropic funds) 
-Dartmouth Health Marketing and Communications (for video and 
web development) 
 
Finally, our study team has partnerships with non-profits, healthcare 
institutions, and other community organizations across New Hampshire 
and Vermont. We will leverage our partnership network for steps such as: 
-identifying events where our research can be conducted 
-identifying healthcare organizations that would like to be present 
at the in-person events to connect participants to screening services 
(e.g., Mt. Ascutney Hospital, DH, Little Rivers Healthcare) 
-reviewing the educational module for accuracy and cultural 
appropriateness 
 
While we will not be providing study participants with medical care, we 
will provide participants with information about local screening services 
and (as feasible at in-person events), work with healthcare/screening 
partners to connect participants with services related to colorectal cancer 
screening (E.g., schedule colonoscopy appointments); provision of any 
medical care and/or screening services. 
 
 
Our recruitment targets are reasonable and feasible given that 
approximately 107,000 people meet the eligibility criteria. 
 
26.0 Multi-Site Research* (Delete this section if this is not a Multi-Site 
Research Study.) 
N/A- While about 23 other cancer centers are also conducting Screen to Save 
educational interventions and evaluation activities, we are all operating 
independently from each other, under our own institutions’ IRBs.