Clinical trial NCT04409782: Education About Health and Cancer Study
Official title: Education About Health and Cancer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Education
Clinical Trial
Research
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dartmouth College
First posted: 2020-06-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in participant knowledge related to what cancer research studies and clinical trials are as assessed before and after educational intervention
timeFrame: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
measure: Percent change in attitudes and behavioral intentions toward enrolling in clinical trials
timeFrame: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
measure: 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
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Geisel School of Medicine at Dartmouth College
name: Judith R Rees, BM, BCh, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: