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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00829 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE2Z14 | Other Identifier | Case Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also increase patient participation in clinical trials.
PRIMARY OBJECTIVES:
I. To develop and pilot test a theory-driven, web-based, tailored, interactive educational program (Oncology Nurse IMPACT: Improving Communication with Patients about Clinical Trials) for oncology nurses to address barriers to discussing clinical trials with patients.
II. To implement Oncology Nurse IMPACT on a national level and conduct a formal program evaluation.
III. To evaluate the mediators and moderators of education program effect on intentions to discuss clinical trials with patients.
OUTLINE: Participants are assigned to 1 of 2 intervention arms.
ARM I: Oncology nurses watch web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers.
ARM II: Oncology nurses view online clinical trials educational materials developed based upon National Cancer Institute (NCI) clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website.
After completion of study intervention, participants are followed for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (IMPACT Intervention) | Experimental | Oncology nurses watch tailored, web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers. |
|
| Arm II (online educational materials) | Active Comparator | Oncology nurses view online clinical trials educational materials developed based upon NCI clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPACT intervention | Other | Tailored, web-based educational short video clips |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in nurse's intention to discuss clinical trials with patients | Behavioral intention will be assessed using 4 items (3 with 7 point scales, strongly agree/strongly disagree and 1 which asks for an estimated number of patients). An analysis of covariance (ANCOVA) will be used to compare intention scores, adjusting for the pre-intervention intention score as well as age, ethnicity, education, access to clinical trials, and years spent in nursing as well as other key factors found to be significantly imbalanced between groups. | Baseline to 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in knowledge, attitudes, normative beliefs, and perceived behavioral control | Actual behavior will be measured using a 3-item scale asking participants to provide an estimate of how many patients they spoke with about cancer clinical trials in the past three months (3-month follow-up) and over the past week (subset of nurses completing the biweekly ecological momentary assessment surveys). An ANCOVA approach will be used to examine effects of the intervention on knowledge, attitudes, behavioral control and normative beliefs. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients enrolled in clinical trials | Up to 3 months post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Meropol, MD | Case Comprehensive Cancer Center | Principal Investigator |
| Barbara Daly, PhD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30782111 | Derived | Flocke SA, Nock NL, Fulton S, Margevicius S, Manne S, Meropol NJ, Daly BJ. A National Study of Oncology Nurses Discussing Cancer Clinical Trials With Patients. West J Nurs Res. 2019 Dec;41(12):1747-1760. doi: 10.1177/0193945919829145. Epub 2019 Feb 19. |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Online education materials | Other | Online NCI-based educational materials |
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| survey administration | Other | Ancillary studies |
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| Baseline to 3 months post-intervention |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |