- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414306
Screen to Save 2: Rural Cancer Screening Educational Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Dartmouth Cancer Center's Community Outreach and Engagement Team will implement Screen to Save 2 using 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. 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.
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 aim of the study is to 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Arm 1
Participants who meet eligibility criteria will be able to enroll and participate on-line, with some participating in online or telephone survey follow-up.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Correct Responses Regarding Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening
Time Frame: pre-test administered immediately before educational intervention; post-test administered immediately after the educational intervention on day 1.
|
A pre-test and post-test are conducted with participants to assess changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 true/false and multiple-choice questions, reported as a percent change in points).
An increased % change in points represents increased knowledge of each survey question and a value of 0 indicates knowledge did not change (a negative value would indicate decreased knowledge).
% change is a unique number that was calculated as the difference between the % answering correctly after the intervention minus the % correct before the intervention; it is representative of the entire data set and not calculated on an individual participant level.
P values (<0.05) are based on chi-square tests.
Each row represents a unique survey question evaluating the topic listed in the row title.
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pre-test administered immediately before educational intervention; post-test administered immediately after the educational intervention on day 1.
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Change in Colorectal Cancer Screening and Other Risk Behavior Intentions
Time Frame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention on day 1
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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 (5), agree, unsure, disagree, strongly disagree(1).
The values reported represent the difference between pre-intervention and post-intervention scores, calculated as a unique number for the total responding participants (not calculated individually).
A positive change represents increased intent.
Each row represents a unique survey question evaluating the topic listed in the row title.
|
pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention on day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge related to lung cancer risk, prevention, and screening
Time Frame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention
|
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).
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pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention
|
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Reach to current and former cigarette smokers
Time Frame: survey administered immediately before educational intervention
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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.
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survey administered immediately before educational intervention
|
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Change in tobacco use frequency
Time Frame: survey administered immediately before educational intervention; approximately 3 months after initial participation in study
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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
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survey administered immediately before educational intervention; approximately 3 months after initial participation in study
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Uptake of lung cancer screening behaviors
Time Frame: approximately 3 months after initial participation in study
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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.
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approximately 3 months after initial participation in study
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Uptake of tobacco quitting behaviors
Time Frame: approximately 3 months after initial participation in study
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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.
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approximately 3 months after initial participation in study
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Collaborators and Investigators
Investigators
- Principal Investigator: Judith Rees, BM, BCh, MPH, PhD, Geisel School of Medicine, Dartmouth College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D20038
- P30CA023108-40S4 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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