Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening

Breast Cancer Clinical Trial

— KinKeeper  

Official title:

Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910350
• Other study ID #: 10-256
• Secondary ID: 1R01NR011323
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: September 23, 2015
• Start date: July 2010
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

1) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To measure functional cancer literacy over time at the individual and familial level and 4) Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and control-comparison groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants:self-identified as Black Latina and Arab women ho can recruit at least two bloodline female family members (mother daughter sister, etc.; can accommodate two in-home visits by a community health worker; and 21-70 years of age.

Exclusion Criteria:

• are not self-identified as Black, Latina, or Arab; do not have direct bloodline relatives; and are younger than 21 or older than 70 years of age.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Kin KeeperSM Cancer Prevention Intervention

Other:
• Standard of care

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Williams KP, Roman L, Meghea CI, Penner L, Hammad A, Gardiner J. Kin KeeperSM: design and baseline characteristics of a community-based randomized controlled trial promoting cancer screening in Black, Latina, and Arab women. Contemp Clin Trials. 2013 Mar;34(2):312-9. doi: 10.1016/j.cct.2012.12.005. Epub 2012 Dec 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First time AND appropriately timed, clinical breast exam, mammogram, pap test	Participants will complete measures every 6 months (baseline, 12 mo., 18 mo., 24 mo., 30 mo. & 36 mo.)to measure increases in screening rates for experimental vs. control group.	Baseline through 36 months.	No
Secondary	Increased Breast and Cervical Cancer Literacy rates.	Do participants have a higher breast and cervical cancer literacy rates post intervention and over 36 months than control group as well as better retention?	Baseline-36 months.	No

External Links

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