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Screen to Save 2: Rural Cancer Screening Educational Intervention

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ClinicalTrials.gov Identifier: NCT04414306
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : March 1, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dartmouth College
Information provided by (Responsible Party):
Anna Tosteson, Trustees of Dartmouth College

Brief Summary:
The purpose of this study is to help the Dartmouth-Hitchcock Norris Cotton Cancer Center and the National Cancer Institute understand how to educate people about cancer screening.

Condition or disease Intervention/treatment Phase
Cancer Colorectal Cancer Lung Cancer Other: In-person cancer screening education Other: Online educational video and website module Other: Online educational video Other: Message from healthcare system and online educational video and website module Not Applicable

Detailed Description:

The Dartmouth-Hitchcock Norris Cotton 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 50-74 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Screening
Official Title: Screen to Save 2: Rural Cancer Screening Educational Intervention
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Arm 1
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.
Other: In-person cancer screening education
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.

Experimental: Experimental Arm 2
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.
Other: Online educational video and website module
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.

Experimental: Experimental Arm 3
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.
Other: Online educational video
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.

Experimental: Experimental Arm 4
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.
Other: Message from healthcare system and online educational video and website module
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 Measures :
  1. Change in knowledge related to colorectal cancer risk, prevention, and screening [ 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 ]
    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).

  2. 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 ]
    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).

  3. Change in colorectal cancer screening behaviors [ Time Frame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study ]
    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).

  4. Change in non-screening cancer prevention behaviors [ Time Frame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study ]
    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 :
  1. 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).

  2. Reach to current and former cigarette smokers [ Time Frame: survey administered immediately before educational intervention ]
    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.

  3. Change in tobacco use frequency [ Time Frame: survey administered immediately before educational intervention; approximately 3 months after initial participation in study ]
    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

  4. Uptake of lung cancer screening behaviors [ Time Frame: approximately 3 months after initial participation in study ]
    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.

  5. Uptake of tobacco quitting behaviors [ Time Frame: approximately 3 months after initial participation in study ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 50-74 at the time of enrollment in the study

Additional Inclusion Criteria for study arm 4:

- Any New Hampshire or Vermont residents age 50-75

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414306


Contacts
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Contact: Katie Lenhoff, MPH (603)-653-9062 Katie.Lenhoff@dartmouth.edu
Contact: Jenna Schiffelbein, MPH 603-653-9960 jenna.e.schiffelbein@dartmouth.edu

Locations
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United States, New Hampshire
Dartmouth-Hitchcock Norris Cotton Cancer Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Katie Lenhoff, MPH    603-653-9062    Katie.Lenhoff@dartmouth.edu   
Contact: Jenna Schiffelbein, MPH    603-653-9960    jenna.e.schiffelbein@dartmouth.edu   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Dartmouth College
Investigators
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Principal Investigator: Anna Tosteson, ScD Dartmouth-Hitchcock Norris Cotton Cancer Center
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Responsible Party: Anna Tosteson, Interim Director, The Dartmouth Institute, Trustees of Dartmouth College
ClinicalTrials.gov Identifier: NCT04414306    
Other Study ID Numbers: D20038
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Tosteson, Trustees of Dartmouth College:
cancer
cancer screening
colorectal cancer
lung cancer
education
rural
lung cancer screening
tobacco
Additional relevant MeSH terms:
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Lung Neoplasms
Colorectal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases