Evaluating Biobanking Educational Tools

NCT01672944 | Completed

• 1 other identifier: MCC-16448
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

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).

Conditions

Neoplasm

Keywords

Biological specimen banks; Health education; Tissue banks; Health care survey; Tissue

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• BANKS-Trust Scale

  Average of 28 days

Study Arms (2)

TBCCN-developed educational materials

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

TBCCN-developed educational materials OTHER

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.

TBCCN-developed educational materials

NCI-developed educational materials OTHER

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."

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for an appointment at Lifetime Cancer Screening (LCS)
• able to read and speak English
• able to provide informed consent
• receiving care at a participating clinic from the Suncoast Community Health Centers network
• able to read and speak Spanish
• able to provide informed consent

You may not qualify if:

• previously diagnosed with cancer
• previously participated in a biobank
• participated in another TBCCN-related study entitled "community perceptions on biobanking"

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Neoplasms; Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Clement Gwede, PhD, MPH, RN

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: September 27, 2010
• Primary Completion: August 31, 2016
• Study Completion: September 17, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (1)