Skip to main content
OpenTrials
Completed

NCT Number: NCT01672944

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasm Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Neoplasms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

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.

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."

Primary outcomes

  1. BANKS-Knowledge Scale

    Time frame: 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.

  2. BANKS-Attitudes Scale

    Time frame: 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.

  3. BANKS-Self-Efficacy Scale

    Time frame: 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.

  4. BANKS-Intentions

    Time frame: Average of 28 days

    Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank.

  5. Decisional Self-Efficacy

    Time frame: 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 outcomes

  1. BANKS-Trust Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2021
First posted
Aug 27, 2012
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.