Education About Health and Cancer Study

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04409782
Collaborator
National Cancer Institute (NCI) (NIH), Norris Cotton Cancer Center (Other), Dartmouth College (Other)
900
1
2
25
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group education
  • Other: Online educational video and website module
N/A

Detailed Description

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

  1. group education (Aim 1a) and

  2. an online format (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 group 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.

Study team will evaluate group educational sessions regarding what clinical trials and cancer research studies are. The 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. Eligible attendees of the class will be optionally invited to participate in the research evaluation of the class, using pre- and post- surveys to assess achievement of the learning objectives. Study participants will also be asked a series of questions to assess study participants' eligibility for existing clinical trials and research studies and, as appropriate, referred to those trial/study/clinical teams for follow-up.

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') about clinical trials and cancer research. The online module's 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. Eligible participants will complete pre- and post- surveys to assess achievement of the learning objectives. Study participants will also be asked a series of questions to assess study participants' eligibility for existing clinical trials and research studies and, as appropriate, referred to those trial/study/clinical teams for follow-up.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Education About Health and Cancer Study
Actual Study Start Date :
Oct 31, 2020
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Registered attendees of a group educational class events will have the option to enroll in the study if meeting eligibility criteria, with some participating in online follow-up.

Other: Group education
Participants will receive education covering the key messages pertaining to cancer research studies and clinical trials, in a group class setting. Education will be facilitated with one or more of the following educational tools: PowerPoint presentation, written materials/handouts, and displays. 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 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 and website module
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.

Outcome Measures

Primary Outcome Measures

  1. Percent change in participant knowledge related to what cancer research studies and clinical trials are as assessed before and after educational intervention [Pre-test questionnaire administered before educational intervention; post-test questionnaire administered 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 11 true/false questions)

  2. Percent change in behavioral intentions toward enrolling in clinical trials [Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention]

    A pre-test and post-test questionnaire conducted with participants to assess any changes in behavioral intensions related to clinical trial enrollment (assessed via 4 Likert-scale questions)

  3. 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 [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]

    Change in enrollment status in cancer research or clinical trials as measured by participant's active status in cancer research or clinical trials project participation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria for Experimental Arm 1 (group education):
  • Age 18 or older at the time of study enrollment
Inclusion Criteria for Experimental Arm 2 (online education):
  • Age 18 or older at the time of study enrollment

  • 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

Exclusion Criteria for both Experimental Arms:
  • Cognitive impairment preventing participation in informed consent process

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03766

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center
  • National Cancer Institute (NCI)
  • Norris Cotton Cancer Center
  • Dartmouth College

Investigators

  • Principal Investigator: Judith R Rees, BM, BCh, MPH, PhD, Geisel School of Medicine at Dartmouth College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Judith R. Rees, Associate Professor of Epidemiology; Associate Professor of Community and Family Medicine; Associate Director for Community Outreach and Engagement, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT04409782
Other Study ID Numbers:
  • D20039
  • P30CA023108-40S4
First Posted:
Jun 1, 2020
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Judith R. Rees, Associate Professor of Epidemiology; Associate Professor of Community and Family Medicine; Associate Director for Community Outreach and Engagement, Dartmouth-Hitchcock Medical Center

Study Results

No Results Posted as of Oct 11, 2021