Education About Health and Cancer Study

This study investigates different ways to educate rural residents living in New Hampshire and Vermont about cancer research studies and clinical trials to increase knowledge of, increase positive attitudes toward, and encourage enrollment in cancer research studies and clinical trials. The information learned from this study will contribute to a nation-wide initiative to educate the public about clinical trials, including a nation-wide evaluation of that initiative. The results of this study may also help researchers understand how education about clinical trials/research affects knowledge of and attitudes toward cancer research and clinical trials, as well as behavioral intentions and actual behaviors related to enrolling in cancer research studies and clinical trials.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Electronic portal education; Other: Online educational video

Detailed Description

The study team will implement and evaluate the research study and clinical trials education in two experimental arms-

1. electronic portal education about clinical trials and cancer research (Aim 1a)
2. online education via an online video about clinical trials and cancer research (Aim 1b)

The education in both formats will be based on a set of key messages that cover information about research studies and clinical trials, including what research studies are, the benefits, the risks, and connection to available research studies and clinical trials

Experimental Arm 1 (Aim 1a):

Implement electronic portal education regarding what clinical trials and cancer research are and evaluate the effect on knowledge of, attitudes and behavioral intentions toward, and actual enrollment into clinical trials and cancer research studies.

We will evaluate educational outputs from electronic portal regarding what clinical trials and cancer research studies are. The educational content for videos was developed with the National Cancer Institute (NCI) toolkit as a foundation, with additional content added to adapt to our local institution, culture, and patient needs. The videos learning objectives focus on improving participants' knowledge about what clinical trials and cancer research studies are and how to access trials and studies, increase positive attitudes toward participating in trials and studies, and increase their intent to enroll in trials and studies.

Providers will receive a BPA indicating patient may qualify to participate in the education survey. See enclosed invitation language. Providers will also have the option to include After Visit Summary (AVS) to Patient Notes that will contain invitation link. Patients will receive a link to the survey. If they choose to take part in the study, they will do so by completing the online consent, eligibility screening, pre-test, and contact information before the class they are registered for; attend the class; and complete the post-test after the class to assess achievement of the learning objectives. They will also be asked a series of questions to assess their eligibility for existing DCC clinical trials and research studies.

Experimental Arm 2 (Aim 1b):

Implement online education regarding what clinical trials and cancer research are and evaluate the effect on knowledge of, attitudes and behavioral intentions toward, and actual enrollment into clinical trials and cancer research studies.

Participants will watch a video and view website materials ('online module') developed by DCC using messaging provided by the National Cancer Institute (NCI) and tailored to our local context. The online module's learning objectives will focus on improving participants' knowledge about what clinical trials and cancer research studies are and how to access trials and studies, increase positive attitudes toward participating in trials and studies, and increase their intent to enroll in trials and studies. Eligible participants will complete pre- and post- surveys to assess achievement of the learning objectives, and they will also be asked a series of questions to assess their eligibility for existing DCC clinical trials and research studies (see enclosed questions).

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Regina-Anne E Cooper, MPH; Phone Number: 6036465466; Email: Regina-Anne.E.Cooper@dartmouth.edu
• Study Contact Backup: Name: Lisa A Purvis, EdD, MPH, MBA; Email: Lisa.a.purvis@dartmouth.edu

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Experimental Arm 1 (portal education):

- Participants will come from Dartmouth Cancer Center electronic provider portal EDH/Epic. They will receive an invitation to participate in this research study only after accessing a Qualtrics survey.

Inclusion Criteria for Experimental Arm 2 (online education):

- Participants must be a resident of one of the RUCC 7-9 counties in NH or VT: Coos, Sullivan Counties in New Hampshire, or Caledonia, Windsor, Windham, Orange, Orleans, Lamoille or Essex Counties in Vermont. They will be invited to participate in the study through social media, listservs, or from flyers in community settings.

Exclusion Criteria for both Experimental Arms:

- Cognitive impairment preventing participation in informed consent process

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 2; People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via a geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.	Other: Online educational video; Participants will receive online education via a video and written web content. Key messages will include information pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.
Experimental: Arm 1; Our study will be largely advertised to DCC's patients and caregivers via electronic provider portal BPA. Providers will provide prospective participants with a link to an online survey where they can consent, complete eligibility screening, the pretest, and contact information.	Other: Electronic portal education; Participants will receive education via an electronic portal covering the key messages pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in participant knowledge related to what cancer research studies and clinical trials are as assessed before and after educational intervention	A pre-test and post-test knowledge questionnaire conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via percent of correct and incorrect responses to 19 true/false questions and 6 multiple choice questions).	Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
Percent change in attitudes and behavioral intentions toward enrolling in clinical trials	A pre-test and post-test questionnaire conducted with participants to assess any changes in attitudes and behavioral intentions related to clinical trial enrollment (assessed via 4 Likert-scale questions)	Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
Percent change in enrollment status in cancer research studies and clinical trials as measured by tracking individual enrollment statuses at the time of intervention and after education	Actual enrollment into a clinical trial or cancer research study will be assessed via Dartmouth Cancer Center (DCC) Office of Clinical Research enrollment records over 6 months post-intervention. Enrollment records for specified DCC trials/research studies will also be assessed, and change in enrollment status in cancer research or clinical trials will be measured by direct participant's active status in cancer research or clinical trials project participation.	Tracking from time of study participation in educational intervention and following study participants for six months monitoring change in enrollment status in cancer research and clinical trials

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI); Dartmouth College
• Investigators: Principal Investigator: Judith R Rees, BM, BCh, MPH, PhD, Geisel School of Medicine at Dartmouth College

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2020
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Research; Clinical Trial; Education
• Other Study ID Numbers: D20039; P30CA023108-40S4 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No