Cancer
Conditions
Keywords
Education, Clinical Trial, 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 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.
Interventions
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.
Sponsors
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Dartmouth College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Comparison of data pre- to post- intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). | 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. |
| Mean Change in Intent to Enroll in Clinical Trials | Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day | 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. |
| 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 | From time of study participation in educational intervention up to six months. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJudith R Rees, BM,BCh,MPH,PhD
Geisel School of Medicine at Dartmouth College
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 14.5 |
| Education College graduate | 206 Participants |
| Education High School | 18 Participants |
| Education Some College | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 254 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 255 Participants |
| Region of Enrollment United States | 260 participants |
| Sex/Gender, Customized Female | 220 Participants |
| Sex/Gender, Customized Male | 36 Participants |
| Sex/Gender, Customized Other/Missing | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 260 |
| other Total, other adverse events | 0 / 260 |
| serious Total, serious adverse events | 0 / 260 |
Outcome results
None listed