Breast CancerNCT00477646
Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
A study testing Prevention Care Management in people with Breast Cancer and Cervical Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening, including helping them to schedule cancer screening appointments. Read more about this study
- Who is it for?
- Ages 50 to 64 years, women only
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Colorectal Cancer
- What is being tested?
- Prevention Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,241 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Feb 2011
- 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 50 to 64 years
- Women only
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Enrolled in a participating Medicaid Managed Care Organization (MMCO) as a Medicaid patient for ≥ 12 months
- Not up-to-date (UTD) for colorectal cancer screening
- UTD status defined by any of the following:
- Home fecal occult blood test within the past 12 months
- Flexible sigmoidoscopy within the past 5 years
- Double-contrast barium enema within the past 5 years
- Colonoscopy within the past 10 years
- Registered to receive primary care from a participating Community/Migrant Health Center, Diagnostic and Treatment Center, or other participating practice in New York City
- Must have a telephone available
- No MMCO claim for any of the following:
- Colorectal, breast, or cervical cancer
- Colon polyp removal
- Total colectomy
PATIENT CHARACTERISTICS:
- Female
- Able to use telephone
- No plans to move for ≥ 1 year
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Directors Network, Incorporated
New York, New York, 10018
About this study
Official title: New York Prevention Care Manager Project / Medicaid Managed Care Organization Version
RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening, including helping them to schedule cancer screening appointments.
PURPOSE: This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal, cervical, and breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Develop and evaluate an enhanced telephone support intervention (Prevention Care Manager [PCM]) to promote colorectal, cervical, and breast cancer screening more widely among women enrolled in a Medicaid Managed Care Organization (MMCO).
- Explore the impact of patient, Community/Migrant Health Center (C/MHC), and MMCO characteristics on cancer screening status and the impact of the intervention.
- Evaluate the impact of the enhanced PCM intervention upon colorectal, breast, and cervical cancer screening rates.
Secondary
- Compare the status of women who are up-to-date (UTD) on CRC screening versus the UTD status of cervical cancer and breast cancer screening.
OUTLINE: This is a randomized, controlled study. The study is conducted in 2 parts.
- Part 1 (barrier interview and pilot testing): Patients are stratified according to primary language and whether or not they have had an outpatient visit in the past year.
- Barrier interview: Patients undergo a 15-30 minute interview to determine barriers they face preventing them from receiving recommended cancer screenings and healthcare, as well as facilitators which have encouraged them to be screened.
- Pilot testing: Patients from the barrier interviews and other eligible Medicaid Managed Care Organization (MMCO) patients receive scripted telephone calls from a Prevention Care Manager to assist them in getting up-to-date on their cancer screening tests over 3 months.
- Part 2 (randomized control trial): Patients are stratified according to treatment center (Community/Migrant health center vs Diagnostic and Treatment Center) and age. Patient are randomized to 1 of 2 intervention arms.
- Arm I (Prevention Care Manager): Patients are stratified according to the number of tests for which they are up-to-date at baseline. Patients receive reminder letters encouraging them to contact their primary care provider for colorectal, breast, and cervical cancer screening and 3 to 4 telephone support calls to help them become up to date for colorectal, breast, and cervical cancer screening.
- Arm II (usual care): Patients receive usual care according to their primary care physician.
In both arms, patients are followed for 18 months.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study.
- Conditions
- Breast Cancer, Cervical Cancer, Colorectal Cancer
- Being tested
- Prevention Care Management
- Keywords
- colon cancer, rectal cancer, breast cancer, cervical cancer
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention Care ManagementBehavioural
Telephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.
| Study group | Role | What they receive |
|---|---|---|
| Prevention Care Management | Experimental | Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening Receives: Behavioral: Prevention Care Management |
| Usual Care | No intervention | Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening
Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.
Measured: 18 months
Secondary outcomes (2)
Percentage of patients UTD for breast and cervical cancer screening
Measured: 18 months
Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Clinical Directors Network
- Investigators
- Allen J. Dietrich, MD, Study chair, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477646
- Sponsor's protocol ID
- CDR0000537346
- Other IDs
- P30CA023108, DMS-20253
- Status last verified
- Aug 2011
- First submitted
- 23 May 2007
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dietrich AJ, Tobin JN, Robinson CM, Cassells A, Greene MA, Dunn VH, Falkenstern KM, De Leon R, Beach ML. Telephone outreach to increase colon cancer screening in medicaid managed care organizations: a randomized controlled trial. Ann Fam Med. 2013 Jul-Aug;11(4):335-43. doi: 10.1370/afm.1469.
PubMed 23835819
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New York Prevention Care Manager Project / Medicaid Managed Care Organization Version
- ClinicalTrials.gov ID
- NCT00477646
- Acronym / sponsor ID
- CDR0000537346
- Conditions
- Breast Cancer, Cervical Cancer, Colorectal Cancer
- Keywords
- colon cancer, rectal cancer, breast cancer, cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,241 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Clinical Directors Network
- Study start
- Jul 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 May 2007 (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.
RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening, including helping them to schedule cancer screening appointments.
PURPOSE: This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal, cervical, and breast cancer.
Detailed description
OBJECTIVES:
Primary
- Develop and evaluate an enhanced telephone support intervention (Prevention Care Manager [PCM]) to promote colorectal, cervical, and breast cancer screening more widely among women enrolled in a Medicaid Managed Care Organization (MMCO).
- Explore the impact of patient, Community/Migrant Health Center (C/MHC), and MMCO characteristics on cancer screening status and the impact of the intervention.
- Evaluate the impact of the enhanced PCM intervention upon colorectal, breast, and cervical cancer screening rates.
Secondary
- Compare the status of women who are up-to-date (UTD) on CRC screening versus the UTD status of cervical cancer and breast cancer screening.
OUTLINE: This is a randomized, controlled study. The study is conducted in 2 parts.
- Part 1 (barrier interview and pilot testing): Patients are stratified according to primary language and whether or not they have had an outpatient visit in the past year.
- Barrier interview: Patients undergo a 15-30 minute interview to determine barriers they face preventing them from receiving recommended cancer screenings and healthcare, as well as facilitators which have encouraged them to be screened.
- Pilot testing: Patients from the barrier interviews and other eligible Medicaid Managed Care Organization (MMCO) patients receive scripted telephone calls from a Prevention Care Manager to assist them in getting up-to-date on their cancer screening tests over 3 months.
- Part 2 (randomized control trial): Patients are stratified according to treatment center (Community/Migrant health center vs Diagnostic and Treatment Center) and age. Patient are randomized to 1 of 2 intervention arms.
- Arm I (Prevention Care Manager): Patients are stratified according to the number of tests for which they are up-to-date at baseline. Patients receive reminder letters encouraging them to contact their primary care provider for colorectal, breast, and cervical cancer screening and 3 to 4 telephone support calls to help them become up to date for colorectal, breast, and cervical cancer screening.
- Arm II (usual care): Patients receive usual care according to their primary care physician.
In both arms, patients are followed for 18 months.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention Care Management | Experimental | Behavioral: Prevention Care ManagementTelephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening |
| Usual Care | No intervention | –Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Prevention Care ManagementTelephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments. | Behavioural | Prevention Care Management |
Primary outcome
Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening
Time frame: 18 months
Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.
2 secondary outcomes
Percentage of patients UTD for breast and cervical cancer screening
Time frame: 18 months
Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening
Time frame: 18 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 5 Aug 2011.
- Derived from this study: PubMed 23835819Dietrich AJ, Tobin JN, Robinson CM, Cassells A, Greene MA, Dunn VH, Falkenstern KM, De Leon R, Beach ML. Telephone outreach to increase colon cancer screening in medicaid managed care organizations: a randomized controlled trial. Ann Fam Med. 2013 Jul-Aug;11(4):335-43. doi: 10.1370/afm.1469.
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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.
Allen J. Dietrich, MD study chair
Norris Cotton Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention Care Management in people with Breast Cancer and Cervical Cancer, run by Dartmouth-Hitchcock Medical Center 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?
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 5 Aug 2011. 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?
Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening (time frame: 18 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 NCT00477646, which also lists 1 linked publication.
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 5 Aug 2011.