NCT01910350

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
516

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable breast-cancer

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

July 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

4.6 years

First QC Date

July 25, 2013

Last Update Submit

September 23, 2015

Conditions

Breast CancerCervical Cancer

Keywords

Breast & cervical cancer prevention & screening

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Increased Breast and Cervical Cancer Literacy rates.

    Baseline-36 months.

Study Arms (2)

Cancer prevention intervention

EXPERIMENTAL

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.

Behavioral: Kin KeeperSM Cancer Prevention Intervention

Control group receives standard care

ACTIVE COMPARATOR

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.

Other: Standard of care

Interventions

Kin KeeperSM Cancer Prevention InterventionBEHAVIORAL
Cancer prevention intervention
Standard of careOTHER
Control group receives standard care

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related 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.

    PMID: 23274402BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 29, 2013

Study Start

July 1, 2010

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

US(1)