- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409782
Education About Health and Cancer Study
Study Overview
Detailed Description
The study team will implement and evaluate the research study and clinical trials education via online video about clinical trials and cancer research
The education 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. We will 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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:
- Cognitive impairment preventing participation in informed consent process
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Arm 1
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in % of Participants With Correct Knowledge Related to What Cancer Research Studies and Clinical Trials Are as Assessed Before and After Educational Intervention, Measured on the Same Day
Time Frame: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day. Number represents change in knowledge (increase in % of respondents getting the answer correct).
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A pre-test and post-test knowledge questionnaire conducted with participants to assess 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 "knowledge" questions.
A large positive number indicates the percent increase in people getting the answer right after the intervention.
% change is a unique number that was calculated as the difference between the % answering correctly after the intervention minus the % correct before the intervention; it is representative of the entire data set and not calculated on an individual participant level.
Each row represents a unique survey question evaluating the topic listed in the row title.
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Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day. Number represents change in knowledge (increase in % of respondents getting the answer correct).
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Mean Change in Intent to Enroll in Clinical Trials
Time Frame: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day
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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 5 Likert-scale questions: 1 Strongly disagree, 2 Disagree, 3 Unsure, 4 Agree, 5 Strongly agree).
The values reported are the mean scores of pre-intervention and post-intervention scores both measured on the same day.
Each row represents a unique survey question evaluating the topic listed in the row title.
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Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day
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Change in Enrollment Status in Cancer Research Studies and Clinical Trials as Measured by Comparing Individual % Enrolled at the Time of Intervention and % Who Have Enrolled Within 6 Months After the Intervention
Time Frame: From time of study participation in educational intervention up to six months.
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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, measured as a change from the baseline value of 0 participants.
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.
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From time of study participation in educational intervention up to six months.
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Collaborators and Investigators
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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