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The purpose of this study is to evaluate English and Spanish language educational materials that inform the community about a type of cancer research that involves the collection, storage, and processing of biospecimens. Part A of this study involved creating surveys about biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to evaluate education materials about biospecimen donation and research.
Phase II consists of two independent randomized controlled trials. Each trial is being conducted independently to test English and Spanish language materials (75 subjects each).
The project addresses gaps in information by developing and validating English and Spanish language instruments to measure knowledge of and attitudes towards biospecimen donation and banking, as well as intention to donate biospecimens to a biobank (Part A). Once developed, the instruments will be used to evaluate biobanking educational priming tools by conducting two independent RCTs. Wherein English educational materials will be tested with 75 participants recruited from an urban clinic, and Spanish educational materials will be tested with 75 participant recruited form a rural community health center network. For each RCT following baseline assessment, participants will be randomized to either: 1) educational priming tools (DVD and booklet) developed by the Tampa Bay Community Cancer Network (TBCCN); or 2) an NCI-developed brochure entitled "Providing Your Tissue for Research: What You Need to Know." Seven to 28 days later participants will be given a telephone follow up interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBCCN-developed educational materials | Experimental | Biobanking educational DVD and booklet kit developed by the Tampa Bay Community Network (TBCCN) Center. English kit is entitled "Biobanking Hope for a Cancer Cure", and Spanish kit is entitled "Biobanco: Una esperanza de cura para el cancer." |
|
| Control Group | Other | Biobanking educational Brochure developed by the National Cancer Institute. English brochure is entitled "Providing your Tissue for Research: What you need to Know", Spanish brochure is entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBCCN-developed educational materials | Other | Participants will be asked to view the educational materials developed by TBCCN, in either English or Spanish depending on the RCT in which they are enrolled. These materials include a DVD and a booklet that were developed to enhance community members' understanding and awareness of biospecimen collection and biobanking from healthy individuals. |
| Measure | Description | Time Frame |
|---|---|---|
| BANKS-Knowledge Scale | Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 16-item questionnaire measuring knowledge about biobanking. | Average of 28 days |
| BANKS-Attitudes Scale | Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 15-item questionnaire measuring attitudes toward biobanking. | Average of 28 days |
| BANKS-Self-Efficacy Scale | Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 12-item questionnaire measuring self-efficacy in regards to donating a biospecimen to a biobank. | Average of 28 days |
| BANKS-Intentions | Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank. | Average of 28 days |
| Decisional Self-Efficacy | Administered at follow-up (between 7 and 28 days after enrollment). Description: A validated 11-item questionnaire measuring participant's confidence in making a decision about donating a biospecimen (O'Connor M.A. Decision Self-efficacy Scale. 1995; www.ohri.ca/decisionaid). | Average of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| BANKS-Trust Scale | Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 10-item questionnaire measuring trust related to organizations, facilities, and people that may be involved in research. | Average of 28 days |
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English Language RCT Inclusion Criteria:
Spanish Language RCT Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clement Gwede, PhD, MPH, RN | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| NCI-developed educational materials | Other | Participants will be asked to view the English biobanking educational Brochure entitled "Providing your Tissue for Research: What you need to Know", or Spanish brochure entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica." |
|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |