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Screen to Save 2: Rural Cancer Screening Educational Intervention

Primary Purpose

Cancer, Colorectal Cancer, Lung Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-person cancer screening education
Online educational video and website module
Online educational video
Message from healthcare system and online educational video and website module
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer focused on measuring cancer, cancer screening, colorectal cancer, lung cancer, education, rural, lung cancer screening, tobacco

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for study arms 1-4:

  • Resident of one of the RUCC 7-9 counties in New Hampshire or Vermont (Coos or Sullivan County, NH; Caledonia, Windsor, Windham, Orange, Orleans, Lamoille, or Essex County, VT) and
  • Age 45-74 at the time of enrollment in the study

Additional Inclusion Criteria for study arm 4:

- Any New Hampshire or Vermont residents age 45-75

Exclusion Criteria:

- Cognitive impairment preventing participation in informed consent process

Three-Month Follow-Up Survey Inclusion Criteria:

A participant will be eligible for inclusion in the three-month follow-up survey if the participant completed the pre-test, educational intervention, and post-test (in-person or through online submission) and at the time of initial participation:

  • Answered a colorectal cancer screening history question indicating that the participant has never received colorectal cancer screening OR does not know if he/she has received colorectal cancer screening previously OR
  • Answered a series of questions indicating that the participant received prior colorectal cancer screening but may be overdue for colorectal cancer screening based on the type of colorectal cancer screening last reported and screening guidelines for the frequency of re-screening.

Six-Month Follow-Up Survey Inclusion Criteria:

A participant will be eligible for inclusion in the six-month follow-up survey if the participant participated in the three-month-follow up survey and at that time reported that having:

  • A FIT/FOBT screening or Cologuard (stool) screening performed since the time of initial study participation, but having not received the results
  • An abnormal FIT/FOBT, or Cologuard (stool) screening since the time of initial study participation, but had not received a diagnostic colonoscopy
  • A colonoscopy since the time of initial study participation, but had not received the final results

Sites / Locations

  • Dartmouth Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Experimental Arm 1

Experimental Arm 2

Experimental Arm 3

Experimental Arm 4

Arm Description

Attendees at in-person events (e.g. health fairs) who meet eligibility criteria will be able to enroll and participate in-person, with some participating in online or telephone survey follow-up.

People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via an age and geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online or telephone follow-up.

People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via an age and geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online or telephone follow-up. This arms will serve as an experimental arm for assessing study aim 2 and as a control arm for study aim 1.

Patients identified by one or more healthcare systems to be due or overdue for colorectal cancer screening will be informed by their healthcare provider or healthcare system (e.g. via the healthcare system's patient portal) that they are due for screening and will be informed how to schedule an colorectal cancer screening related appointment (e.g. discussion with primary care provider about colorectal cancer screening options) along with the option to receive education about colorectal cancer screening. Patients who are interested in receiving education may view the education with or without participating in the research study. Patients who elect to be study participants will participate in consenting, eligibility screening, pre-test, post-test, and possible three- and six-month using a parallel structure to study arms two and three.

Outcomes

Primary Outcome Measures

Change in knowledge related to colorectal cancer risk, prevention, and screening
A pre-test and post-test are conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 true/false and multiple choice questions). Participants meeting eligibility criteria for inclusion in the three-month follow-up survey will also answer knowledge questions related to key learning outcomes in the three-month follow-up survey (assessed via 18 true/false and multiple choice questions).
Change in colorectal cancer screening and other risk behavior intentions
A pre-test and post-test are conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 5-point Likert scale: strongly agree, agree, unsure, disagree, strongly disagree).
Change in colorectal cancer screening behaviors
Participants meeting the inclusion criteria for the three-month follow-up survey will answer three yes/no/decline to answer questions asked in the three-month follow-up survey regarding colorectal cancer screening behaviors. These questions are followed by a skip logic of additional multiple choice and free response questions to assess the nature of the changes (e.g. type of screening used).
Change in non-screening cancer prevention behaviors
Participants meeting the inclusion criteria for participation in the three-month follow-up survey will be asked two yes/no/decline to answer questions related to exercise/activity and diet since the time of initial participation in the study. These questions are followed by a skip logic of additional multiple choice questions to discern the direction of the change (e.g. increased/decreased physical activity; increased/decreased healthy eating habits).

Secondary Outcome Measures

Change in knowledge related to lung cancer risk, prevention, and screening
A pre-test and post-test are conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 6 true/false questions).
Reach to current and former cigarette smokers
Number and percentage of participants who indicate that they have quit smoking cigarettes within the last 15 years and the number and percentage of participants who indicate current tobacco use.
Change in tobacco use frequency
Participants meeting the inclusion criteria for the three-month follow-up survey will answer a question about their current tobacco use (every day, some day, not at all, decline to answer) and responses will be compared to participants' answers to the same question administered approximately three months earlier before receiving the educational intervention
Uptake of lung cancer screening behaviors
Participants meeting the inclusion criteria for the three-month follow-up survey will answer two yes/no/decline to answer questions asked in the three-month follow-up survey regarding lung cancer screening behaviors since their initial participation in the study approximately three months earlier.
Uptake of tobacco quitting behaviors
Participants meeting the inclusion criteria for the three-month follow-up survey will answer four yes/no/decline to answer questions asked in the three-month follow-up survey regarding use of tobacco quitting services and quitting behavior since their initial participation in the study approximately three months earlier.

Full Information

First Posted
June 1, 2020
Last Updated
August 1, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI), Dartmouth College
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1. Study Identification

Unique Protocol Identification Number
NCT04414306
Brief Title
Screen to Save 2: Rural Cancer Screening Educational Intervention
Official Title
Screen to Save 2: Rural Cancer Screening Educational Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI), Dartmouth College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to help the Dartmouth Cancer Center and the National Cancer Institute understand how to educate people about cancer screening.
Detailed Description
The Dartmouth Cancer Center's Community Outreach and Engagement Team will implement Screen to Save 2 in two formats-traditional outreach using in-person fairs and an online format. The education in both formats will be based on a set of key messages that cover information about colorectal cancer, including risk factors, prevention, screening recommendations, and screening options. Key messages provided by the National Cancer Institute will be tailored to the local context of NH and VT, including information about local options for getting screened for colorectal cancer. A third arm will receive education about lung cancer screening. This third arm will serve as the control arm for the first two arms (the arms receiving in-person or online colorectal cancer screening education) to assess study Aim 1. This third arm will also serve as an intervention arm for assessing Study Aim 2. Using online or telephone surveys, some participants will be contacted approximately three months after their initial participation. Some of the participants contacted after three months will again be contacted another three months later (six months after initial participation). The three- and six-month surveys will assess knowledge, attitudes, beliefs, and behaviors related to cancer screening, including outcomes from cancer screening. The primary aims of the study are as follows: Aim 1: Implement and evaluate Screen to Save 2 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 the target population. Aim 1a: Conduct cancer screening fairs in Rural Urban Continuum Code (RUCC) 7-9 counties, using the Screen to Save 2 framework and materials and, where feasible, coordinate with local service providers to make colorectal cancer screening services available to event attendees. Aim 1b: Utilize web-based module to conduct targeted outreach about colorectal cancer screening using the Screen to Save 2 framework and materials and refer them to locally-available screenings, healthcare provider systems, and/or healthcare coverage systems. The secondary aim of the study is: Aim 2: Evaluate online educational activities' ability to reach 45-74 year old current and former tobacco users from rural (RUCC 7-9) counties, increase lung cancer screening knowledge among that demographic, and encourage engagement with local tobacco treatment resources and lung cancer screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Colorectal Cancer, Lung Cancer
Keywords
cancer, cancer screening, colorectal cancer, lung cancer, education, rural, lung cancer screening, tobacco

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants whose initial engagement with the study via online study arms 2 and 3 will not know that they are being randomly assigned to one of two educational interventions: a video and website module about colorectal cancer screening or a video about lung cancer screening, and will not be told about the in-person educational arm. Participants in the in-person educational arm may be told that others are participating online as part of the study, but will not be told about he lung cancer screening video specifically.
Allocation
Randomized
Enrollment
950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm 1
Arm Type
Experimental
Arm Description
Attendees at in-person events (e.g. health fairs) who meet eligibility criteria will be able to enroll and participate in-person, with some participating in online or telephone survey follow-up.
Arm Title
Experimental Arm 2
Arm Type
Experimental
Arm Description
People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via an age and geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online or telephone follow-up.
Arm Title
Experimental Arm 3
Arm Type
Experimental
Arm Description
People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via an age and geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online or telephone follow-up. This arms will serve as an experimental arm for assessing study aim 2 and as a control arm for study aim 1.
Arm Title
Experimental Arm 4
Arm Type
Experimental
Arm Description
Patients identified by one or more healthcare systems to be due or overdue for colorectal cancer screening will be informed by their healthcare provider or healthcare system (e.g. via the healthcare system's patient portal) that they are due for screening and will be informed how to schedule an colorectal cancer screening related appointment (e.g. discussion with primary care provider about colorectal cancer screening options) along with the option to receive education about colorectal cancer screening. Patients who are interested in receiving education may view the education with or without participating in the research study. Patients who elect to be study participants will participate in consenting, eligibility screening, pre-test, post-test, and possible three- and six-month using a parallel structure to study arms two and three.
Intervention Type
Other
Intervention Name(s)
In-person cancer screening education
Intervention Description
Participants will receive verbal instruction covering the key messages, including risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. These in-person programs will take place in a variety of settings such as community-based organizations (e.g., community businesses, libraries, faith-based organizations, senior centers), fairs and community events, and clinical centers (e.g., health centers, local hospitals). Depending on the setting, education will be facilitated with one or more of the following educational tools: inflatable colon exhibit, PowerPoint presentation, flip chart/flip book, written materials/handouts, and displays. Data will be collected via pre- and post-tests. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
Intervention Type
Other
Intervention Name(s)
Online educational video and website module
Intervention Description
Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
Intervention Type
Other
Intervention Name(s)
Online educational video
Intervention Description
Participants will receive online education via a video and website about lung cancer screening. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
Intervention Type
Other
Intervention Name(s)
Message from healthcare system and online educational video and website module
Intervention Description
Patients at one or more healthcare systems will receive a message from their healthcare provider or healthcare system indicating that they are due or overdue for colorectal cancer screening and receive information on how to schedule a related care (e.g. appointment with primary care provider to discuss screening options) and have the option of receiving education via on online video and website module with or without research study participation. Only recipients of this information who opt into the study through a consenting process will be considered study participants. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
Primary Outcome Measure Information:
Title
Change in knowledge related to colorectal cancer risk, prevention, and screening
Description
A pre-test and post-test are conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 true/false and multiple choice questions). Participants meeting eligibility criteria for inclusion in the three-month follow-up survey will also answer knowledge questions related to key learning outcomes in the three-month follow-up survey (assessed via 18 true/false and multiple choice questions).
Time Frame
pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; survey approximately 3 months after initial engagement in study
Title
Change in colorectal cancer screening and other risk behavior intentions
Description
A pre-test and post-test are conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 5-point Likert scale: strongly agree, agree, unsure, disagree, strongly disagree).
Time Frame
pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention
Title
Change in colorectal cancer screening behaviors
Description
Participants meeting the inclusion criteria for the three-month follow-up survey will answer three yes/no/decline to answer questions asked in the three-month follow-up survey regarding colorectal cancer screening behaviors. These questions are followed by a skip logic of additional multiple choice and free response questions to assess the nature of the changes (e.g. type of screening used).
Time Frame
pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study
Title
Change in non-screening cancer prevention behaviors
Description
Participants meeting the inclusion criteria for participation in the three-month follow-up survey will be asked two yes/no/decline to answer questions related to exercise/activity and diet since the time of initial participation in the study. These questions are followed by a skip logic of additional multiple choice questions to discern the direction of the change (e.g. increased/decreased physical activity; increased/decreased healthy eating habits).
Time Frame
pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study
Secondary Outcome Measure Information:
Title
Change in knowledge related to lung cancer risk, prevention, and screening
Description
A pre-test and post-test are conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 6 true/false questions).
Time Frame
pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention
Title
Reach to current and former cigarette smokers
Description
Number and percentage of participants who indicate that they have quit smoking cigarettes within the last 15 years and the number and percentage of participants who indicate current tobacco use.
Time Frame
survey administered immediately before educational intervention
Title
Change in tobacco use frequency
Description
Participants meeting the inclusion criteria for the three-month follow-up survey will answer a question about their current tobacco use (every day, some day, not at all, decline to answer) and responses will be compared to participants' answers to the same question administered approximately three months earlier before receiving the educational intervention
Time Frame
survey administered immediately before educational intervention; approximately 3 months after initial participation in study
Title
Uptake of lung cancer screening behaviors
Description
Participants meeting the inclusion criteria for the three-month follow-up survey will answer two yes/no/decline to answer questions asked in the three-month follow-up survey regarding lung cancer screening behaviors since their initial participation in the study approximately three months earlier.
Time Frame
approximately 3 months after initial participation in study
Title
Uptake of tobacco quitting behaviors
Description
Participants meeting the inclusion criteria for the three-month follow-up survey will answer four yes/no/decline to answer questions asked in the three-month follow-up survey regarding use of tobacco quitting services and quitting behavior since their initial participation in the study approximately three months earlier.
Time Frame
approximately 3 months after initial participation in study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for study arms 1-4: Resident of one of the RUCC 7-9 counties in New Hampshire or Vermont (Coos or Sullivan County, NH; Caledonia, Windsor, Windham, Orange, Orleans, Lamoille, or Essex County, VT) and Age 45-74 at the time of enrollment in the study Additional Inclusion Criteria for study arm 4: - Any New Hampshire or Vermont residents age 45-75 Exclusion Criteria: - Cognitive impairment preventing participation in informed consent process Three-Month Follow-Up Survey Inclusion Criteria: A participant will be eligible for inclusion in the three-month follow-up survey if the participant completed the pre-test, educational intervention, and post-test (in-person or through online submission) and at the time of initial participation: Answered a colorectal cancer screening history question indicating that the participant has never received colorectal cancer screening OR does not know if he/she has received colorectal cancer screening previously OR Answered a series of questions indicating that the participant received prior colorectal cancer screening but may be overdue for colorectal cancer screening based on the type of colorectal cancer screening last reported and screening guidelines for the frequency of re-screening. Six-Month Follow-Up Survey Inclusion Criteria: A participant will be eligible for inclusion in the six-month follow-up survey if the participant participated in the three-month-follow up survey and at that time reported that having: A FIT/FOBT screening or Cologuard (stool) screening performed since the time of initial study participation, but having not received the results An abnormal FIT/FOBT, or Cologuard (stool) screening since the time of initial study participation, but had not received a diagnostic colonoscopy A colonoscopy since the time of initial study participation, but had not received the final results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Rees, BM, BCh, MPH, PhD
Organizational Affiliation
Geisel School of Medicine, Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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