NCT02205749

Brief Summary

Research with stored biospecimens can provide substantial societal benefits, including greater understanding of cancer etiology and discovery of new cancer therapies, but one critical social and ethical issue is the use of samples for research unplanned at the time of biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out, broad consent, study-specific consent) have been proposed for secondary research use of biospecimens, but empirical data on individuals' preferences for different consent models are limited, particularly from those with limited health literacy and from racial and ethnic minority groups. It is critically important to understand the consent preferences of diverse individuals, as participation of all population subgroups in biobanks is essential to reach translational cancer research goals. Based on a social ecological conceptual framework, the investigators will examine preferences for consent models for secondary research uses of biospecimens among a racially and socioeconomically diverse sample of women 35 years of age and older. The investigators aim to compare experimentally the effect of consent model on intentions to donate biospecimens for future research use among a diverse sample of women. The investigators hypothesize that women will have stronger intentions to donate based on the broad model of consent and the study-specific model of consent compared with the notice model of consent. These findings from groups underrepresented in research will be critical since the participation of these groups in biobanks is essential to generating findings that will achieve translational research goals of eliminating cancer disparities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

July 29, 2014

Last Update Submit

May 7, 2018

Conditions

Biospecimen Donation

Keywords

biobanksinformed consenthealth literacy

Outcome Measures

Primary Outcomes (1)

  • Intent to Donate

    Intention to donate to a biobank.

    Immediate

Secondary Outcomes (1)

  • Consent Model Preference

    Immediate

Study Arms (3)

Study-specific consent model

OTHER

• Review plain language brochure describing consent to a biobank based on the study-specific model of consent

Behavioral: Study-specific consent modelBehavioral: Broad consent modelBehavioral: Notice consent model

Broad consent model

OTHER

• Review plain language brochure describing consent to a biobank based on the broad model of consent

Behavioral: Study-specific consent modelBehavioral: Broad consent modelBehavioral: Notice consent model

Notice consent model

OTHER

• Review plain language brochure describing consent to a biobank based on the notice model of consent

Behavioral: Study-specific consent modelBehavioral: Broad consent modelBehavioral: Notice consent model

Interventions

Study-specific consent modelBEHAVIORAL

• Review plain language brochure describing consent to a biobank based on the study-specific model of consent

Broad consent modelNotice consent modelStudy-specific consent model
Broad consent modelBEHAVIORAL

• Review plain language brochure describing consent to a biobank based on the broad model of consent

Broad consent modelNotice consent modelStudy-specific consent model
Notice consent modelBEHAVIORAL

• Review plain language brochure describing consent to a biobank based on the notice model of consent

Broad consent modelNotice consent modelStudy-specific consent model

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Proficient in English
  • Identifies as Non-Hispanic
  • Identifies as African-American or Black
  • Identifies as Caucasian or White
  • Identifies as Female

You may not qualify if:

  • Under 35 years old
  • Not proficient in English
  • Identifies as Hispanic
  • Identifies as a race other than African-American or Black; or Caucasian or White
  • Identifies as more than one race
  • Identifies as Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Study Officials

  • Kimberly A Kaphingst, ScD

    The University of Utah

    PRINCIPAL INVESTIGATOR

  • Bettina Drake, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 31, 2014

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

US(1)