Evaluating Biobanking Educational Tools

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Evaluating Biobanking Educational Tools

Conditions
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Neoplasm

Intervention / Treatment
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* Other: TBCCN-developed educational materials
* Other: NCI-developed educational materials


Participation Criteria
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Eligibility Criteria
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English Language RCT Inclusion Criteria: scheduled for an appointment at Lifetime Cancer Screening (LCS) able to read and speak English able to provide informed consent Spanish Language RCT Inclusion Criteria: receiving care at a participating clinic from the Suncoast Community Health Centers network able to read and speak Spanish able to provide informed consent Exclusion Criteria: previously diagnosed with cancer previously participated in a biobank participated in another TBCCN-related study entitled community perceptions on biobanking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBCCN-developed educational materials<br>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. | Other: TBCCN-developed educational materials<br>* 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.<br>|
| Other: Control Group<br>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. | Other: NCI-developed educational materials<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biological specimen banks, Health education, Tissue banks, Health care survey, Tissue