Breast CancerKinKeeperNCT01910350
Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
A study testing Kin KeeperSM Cancer Prevention Intervention in people with Breast Cancer and Cervical Cancer, run by Michigan State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- Kin KeeperSM Cancer Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
- 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.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- Kin KeeperSM Cancer Prevention Intervention, Standard of care
- Keywords
- Breast & cervical cancer prevention & screening
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kin KeeperSM Cancer Prevention InterventionBehavioural
Standard of careOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 36 months.
Secondary outcomes (1)
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?
Measured: Baseline-36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJul 2010
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Karen Williams, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910350
- Sponsor's protocol ID
- 10-256
- Other IDs
- 1R01NR011323
- Acronym
- KinKeeper
- Status last verified
- Sep 2015
- First submitted
- 25 Jul 2013
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23274402Williams KP, Todem D, Roman LA, Meghea CI, Ford S. Kin KeeperSM Breast and Cervical Cancer Prevention: An Educational Intervention: A Community-Based Randomized Controlled Trial in Black, Latina, and Arab Women. J Cancer Educ. 2026 Mar 20. doi: 10.1007/s13187-026-02851-y. Online ahead of print.
PubMed 41860672
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
- ClinicalTrials.gov ID
- NCT01910350
- Acronym / sponsor ID
- KinKeeper / 10-256
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- Breast & cervical cancer prevention & screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer prevention intervention | Experimental | Behavioral: Kin KeeperSM Cancer Prevention InterventionCancer 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. |
| Control group receives standard care | Active comparator | Other: Standard of careThe 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kin KeeperSM Cancer Prevention Intervention | Behavioural | Cancer prevention intervention |
| Standard of care | Other | Control group receives standard care |
Primary outcome
First time AND appropriately timed, clinical breast exam, mammogram, pap test
Time frame: Baseline through 36 months.
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.
1 secondary outcome
Increased Breast and Cervical Cancer Literacy rates.
Time frame: Baseline-36 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Background: PubMed 23274402Williams 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.
- Derived from this study: PubMed 41860672Williams KP, Todem D, Roman LA, Meghea CI, Ford S. Kin KeeperSM Breast and Cervical Cancer Prevention: An Educational Intervention: A Community-Based Randomized Controlled Trial in Black, Latina, and Arab Women. J Cancer Educ. 2026 Mar 20. doi: 10.1007/s13187-026-02851-y. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kin KeeperSM Cancer Prevention Intervention in people with Breast Cancer and Cervical Cancer, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First time AND appropriately timed, clinical breast exam, mammogram, pap test (time frame: Baseline through 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910350, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.