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Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening (KinKeeper)

Primary Purpose

Breast Cancer, Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kin KeeperSM Cancer Prevention Intervention
Standard of care
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast & cervical cancer prevention & screening

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Michigan State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cancer prevention intervention

Control group receives standard care

Arm Description

Cancer prevention intervention: Experimental group receives intensive 2 hour education in each breast and cervical cancer risks and prevention intervention, and face to face reading of post intervention surveys by an community health worker.

The control group receives reading materials and brochures on breast and cervical cancer such as one would receive in a doctors office and post condition surveys. All materials are read by the participant without the interaction or assistance of the community health worker.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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?

Full Information

First Posted
July 25, 2013
Last Updated
September 23, 2015
Sponsor
Michigan State University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01910350
Brief Title
Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
Acronym
KinKeeper
Official Title
Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
Breast & cervical cancer prevention & screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cancer prevention intervention
Arm Type
Experimental
Arm Description
Cancer prevention intervention: Experimental group receives intensive 2 hour education in each breast and cervical cancer risks and prevention intervention, and face to face reading of post intervention surveys by an community health worker.
Arm Title
Control group receives standard care
Arm Type
Active Comparator
Arm Description
The control group receives reading materials and brochures on breast and cervical cancer such as one would receive in a doctors office and post condition surveys. All materials are read by the participant without the interaction or assistance of the community health worker.
Intervention Type
Behavioral
Intervention Name(s)
Kin KeeperSM Cancer Prevention Intervention
Intervention Type
Other
Intervention Name(s)
Standard of care
Primary Outcome Measure Information:
Title
First time AND appropriately timed, clinical breast exam, mammogram, pap test
Description
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.
Time Frame
Baseline through 36 months.
Secondary Outcome Measure Information:
Title
Increased Breast and Cervical Cancer Literacy rates.
Description
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?
Time Frame
Baseline-36 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23274402
Citation
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.
Results Reference
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Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening

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