Clinical trial NCT04414306: Screen to Save 2: Rural Cancer Screening Educational Intervention
Official title: Screen to Save 2: Rural Cancer Screening Educational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Colorectal Cancer
Lung Cancer
Keywords: cancer
cancer screening
colorectal cancer
lung cancer
education
rural
lung cancer screening
tobacco
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dartmouth College
First posted: 2020-06-04
Enrollment: 382
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Change in knowledge related to colorectal cancer risk, prevention, and screening
timeFrame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; survey approximately 3 months after initial engagement in study
measure: Change in colorectal cancer screening and other risk behavior intentions
timeFrame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention
measure: Change in colorectal cancer screening behaviors
timeFrame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study
measure: Change in non-screening cancer prevention behaviors
timeFrame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study
Secondary outcomes:
measure: Change in knowledge related to lung cancer risk, prevention, and screening
timeFrame: pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention
measure: Reach to current and former cigarette smokers
timeFrame: survey administered immediately before educational intervention
measure: Change in tobacco use frequency
timeFrame: survey administered immediately before educational intervention; approximately 3 months after initial participation in study
measure: Uptake of lung cancer screening behaviors
timeFrame: approximately 3 months after initial participation in study
measure: Uptake of tobacco quitting behaviors
timeFrame: approximately 3 months after initial participation in study
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Cancer Center
state: New Hampshire
Study officials:
affiliation: Geisel School of Medicine, Dartmouth College
name: Judith Rees, BM, BCh, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: