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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA023108-40S4 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Dartmouth College | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online educational video | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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). |
| Mean Change in Intent to Enroll 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 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. | Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day |
| 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 | 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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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
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| Name | Affiliation | Role |
|---|---|---|
| Judith R Rees, BM,BCh,MPH,PhD | Geisel School of Medicine at Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | All participants | Posted | Number | Change in % | 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). |
1 day
This was an educational intervention (video-based) with pre- and post questions. Adverse events did not occur
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | All participants were exposed to the intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Judy Rees | Dartmouth College | 603 646 5492 | judith.r.rees@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2026 | May 1, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2026 | May 28, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Comparison of data pre- to post- intervention
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|
| From time of study participation in educational intervention up to six months. |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education High School | Count of Participants | Participants |
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| Education Some College | Count of Participants | Participants |
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| Education College graduate | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. 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. |
|
|
|
| Primary | Mean Change in Intent to Enroll 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 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. | All participants | Posted | Mean | Standard Deviation | score on a scale | Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day |
|
|
|
|
| Primary | 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 | 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. | Participants who enrolled in a trial within 6 months after the intervention. | Posted | Number | Change in % enrolled | From time of study participation in educational intervention up to six months. |
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|
|
| 260 |
| 0 |
| 260 |
| 0 |
| 260 |
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| It is important for minority groups to participate in clinical trials |
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| I'd consider talking to my doctor/health care provider about clinical trials that are right for me |
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| I am likely to join a clinical trial |
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| I am likely to talk to family/friends about joining a clinical trial |
|
| t-test, 1 sided |
| <0.0001 |
| Other |
| Change in intent relating to survey question "It is important for minority groups to participate in clinical trials" | t-test, 1 sided | <0.0001 | Other |
| Change in intent in relation to survey question "I would consider talking to my doctor or health care provider about clinical trials that are right for me" | t-test, 1 sided | >0.05 | Other |
| Change in intent in relation to survey question "I am likely to join a clinical trial" | t-test, 1 sided | 0.0013 | Other |
| Change in intent in relation to survey question "I am likely to talk to family/friends about joining a clinical trial" | t-test, 1 sided | <0.0001 | Other |