Evaluating Biobanking Educational Tools

Neoplasm Clinical Trial

Official title:

Evaluating Biobanking Educational Tools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672944
• Other study ID #: MCC-16448
• Status: Completed
• Phase: N/A
• Start date: September 27, 2010
• Est. completion date: September 17, 2021

Study information

• Verified date: September 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: September 17, 2021
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Neoplasm

Intervention

Other:
• TBCCN-developed educational materials
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.
• NCI-developed educational materials
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."

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	BANKS-Intentions	Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank.	Average of 28 days
Primary	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	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

External Links

•   Moffitt Cancer Center Clinical Trials website