Evaluating Biobanking Educational Tools

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).

Study Overview

• Status: Completed
• Conditions: Neoplasm
• Intervention / Treatment: Other: TBCCN-developed educational materials; Other: NCI-developed educational materials

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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"

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TBCCN-developed educational materials; 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; 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.
Other: Control Group; 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; 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."

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Clement Gwede, PhD, MPH, RN, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2010
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): September 17, 2021

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (Estimate): August 27, 2012

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Tissue; Health education; Biological specimen banks; Tissue banks; Health care survey
• Other Study ID Numbers: MCC-16448