Evaluating Biobanking Educational Tools

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01672944

Collaborator

(none)

339

Enrollment

Location

Arms

131.7

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Neoplasm	Other: TBCCN-developed educational materials Other: NCI-developed educational materials	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

339 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Evaluating Biobanking Educational Tools

Actual Study Start Date :

Sep 27, 2010

Actual Primary Completion Date :

Aug 31, 2016

Actual Study Completion Date :

Sep 17, 2021

Arms and Interventions

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."

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."

Outcome Measures

Primary Outcome Measures

BANKS-Knowledge Scale [Average of 28 days]
Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 16-item questionnaire measuring knowledge about biobanking.
BANKS-Attitudes Scale [Average of 28 days]
Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 15-item questionnaire measuring attitudes toward biobanking.
BANKS-Self-Efficacy Scale [Average of 28 days]
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.
BANKS-Intentions [Average of 28 days]
Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank.
Decisional Self-Efficacy [Average of 28 days]
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).

Secondary Outcome Measures

BANKS-Trust Scale [Average of 28 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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"