Evaluating Biobanking Educational Tools

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01672944
First received: August 22, 2012
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention
Neoplasm
Other: TBCCN-developed educational materials
Other: NCI-developed educational materials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluating Biobanking Educational Tools

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • BANKS-Knowledge Scale [ Time Frame: Average of 28 days ] [ Designated as safety issue: No ]
    Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 16-item questionnaire measuring knowledge about biobanking.

  • BANKS-Attitudes Scale [ Time Frame: Average of 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average of 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average of 28 days ] [ Designated as safety issue: No ]
    Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank.

  • Decisional Self-Efficacy [ Time Frame: Average of 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average of 28 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 339
Study Start Date: October 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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."

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672944

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Clement Gwede, Ph.D., RN H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01672944     History of Changes
Other Study ID Numbers: MCC-16448
Study First Received: August 22, 2012
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Biological specimen banks
Health education
Tissue banks
Health care survey
Tissue

ClinicalTrials.gov processed this record on September 16, 2014