Clinical trial NCT01672944: Evaluating Biobanking Educational Tools
Official title: Evaluating Biobanking Educational Tools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm
Keywords: Biological specimen banks
Health education
Tissue banks
Health care survey
Tissue
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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 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"

Primary outcomes:
measure: BANKS-Knowledge Scale
timeFrame: Average of 28 days
measure: BANKS-Attitudes Scale
timeFrame: Average of 28 days
measure: BANKS-Self-Efficacy Scale
timeFrame: Average of 28 days
measure: BANKS-Intentions
timeFrame: Average of 28 days
measure: Decisional Self-Efficacy
timeFrame: Average of 28 days
Secondary outcomes:
measure: BANKS-Trust Scale
timeFrame: Average of 28 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Clement Gwede, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: