Cervical CancerNCT01361035
Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
A study testing Cancer risk communication skills training in people with Cervical Cancer and Breast Cancer, run by Tulane University School of Medicine at 5 sites in United States.
Trial summary
What's the purpose of this study? This 4-year study is designed: (1) to teach primary care physicians how to recognize low health literacy patients and effectively counsel them on cancer screening using risk communication and shared decision making and (2) to assess the impact of training on changes in physician… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- Cancer risk communication skills training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2008to Jun 2012
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physician
- Physicians who practice at these clinic sites at least one half day per week are eligible to participate in this study.
- Patient
- Eligible patients include men and women age 40 to 75, individuals enrolled in the clinic practice for at least one year, and individuals identified as having low or inadequate health literacy via the Rapid Estimate of Adult Literacy in Medicine.
Who cannot join
- Physician
- Any provider planning to leave before the end of 12 months will be excluded.
- Patient
- Patients will be excluded if they plan to change primary care provider or site of health plan, have resided in the United States for less than five years, or do not speak English
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Tulane Communty Health Center at Covenant House
New Orleans, Louisiana, 70112
Tulane Faculty Practice
New Orleans, Louisiana, 70112
EXCELth - Ida Hymel Community Health Center
New Orleans, Louisiana, 70114
DCSNO St Cecelia Medical Center
New Orleans, Louisiana, 70117
DCSNO Carrollton Medical Center
New Orleans, Louisiana, 70118
About this study
What's the purpose of this study? This 4-year study is designed: (1) to teach primary care physicians how to recognize low health literacy patients and effectively counsel them on cancer screening using risk communication and shared decision making and (2) to assess the impact of training on changes in physician communication behavior and changes in low health literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis that physician training in cancer screening guidelines, health literacy, and communication skills will improve provider-patient interactions during encounters dealing with preventive health maintenance especially cancer screening.
How will the proposed study be implemented? Thirty-two physicians in the New Orleans metropolitan area will be recruited and randomly assigned to one of two groups. The unit of randomization will be the health care organization or clinic. The intervention group will receive training in health literacy, cancer screening, risk communication and shared decision-making. The control group will not receive communication training until the end of the study. Physicians in both groups will undergo three clinic visits with standardized patients (actors trained to portray real patients; mystery shoppers) but they will not be aware that they are conducting visits with actors. The visits will occur at study enrollment and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate the physicians' communication skills. Each physician assigned to the intervention group will receive verbal feedback on communication skills from the standardized patients and complete a web-based tutorial. Physicians in the control group will not have access to the web-based tutorial until the end of the study.
For each physician, 10-15 patients with limited health literacy will be recruited to the study. Each patient will rate his/her perceived involvement with care and global satisfaction with care at study enrollment and annually for three years. Age and gender-appropriate referral rates for breast, cervical and colorectal cancer screening and patients' receipt of such screening will be assessed annually for three years. All study physicians, regardless of group assignment, will receive performance feedback (report cards) on their cancer screening rates among low health literacy patients in their clinic.
- Conditions
- Cervical Cancer, Breast Cancer, Colorectal Cancer
- Being tested
- Cancer risk communication skills training
- Keywords
- health literacy, cancer screening, doctor-patient communication, standardized patient, continuing medical education
- Medical subject headings
- Uterine Cervical Neoplasms, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer risk communication skills trainingOther
Intervention physicians receive training in cancer risk communication and shared decision making (SDM). At the end of each visit with intervention physicians, standardized patients (SPs) reveal themselves as actors and give structured verbal feedback. After baseline SP visits, each intervention physician undergoes academic detailing with a communication expert. Intervention physicians are directed to a web-based communication skills tutorial where SP ratings are hyperlinked to key references for supplemental reading. Both study groups will receive annual reports detailing their patients' cancer screening status and aggregate ratings of their communication style.
| Study group | Role | What they receive |
|---|---|---|
| No communication training | No intervention | Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making |
| Cancer risk ommunication skills training | Other | Physicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making Receives: Other: Cancer risk communication skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cervical, breast and colorectal cancer screening rates
Cervical/Breast/Colorectal cancer screening rates will be measured at baseline and annually for 2 years to assess whether screening rates improve over time
Measured: 0, 12, 24 months
Secondary outcomes (1)
Change in standardized patient ratings of physician communication behaviors
The mystery shoppers (standardized patients) will rate the physicians' shared decision making and counseling about cancer screening prior to the intervention at baseline and then again at 6-month and 12-month follow up evaluations to assess whether communication behaviors improve over time
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJun 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Eboni Price-Haywood, Tulane University School of Medicine
- Investigators
- Eboni Price-Haywood, MD, MPH, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361035
- Sponsor's protocol ID
- RWJF-63523
- Status last verified
- Mar 2017
- First submitted
- 24 May 2011
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Price-Haywood EG, Roth KG, Shelby K, Cooper LA. Cancer risk communication with low health literacy patients: a continuing medical education program. J Gen Intern Med. 2010 May;25 Suppl 2(Suppl 2):S126-9. doi: 10.1007/s11606-009-1211-6.
PubMed 20352506Price-Haywood EG, Harden-Barrios J, Cooper LA. Comparative effectiveness of audit-feedback versus additional physician communication training to improve cancer screening for patients with limited health literacy. J Gen Intern Med. 2014 Aug;29(8):1113-21. doi: 10.1007/s11606-014-2782-4. Epub 2014 Feb 4.
PubMed 24590734Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.
PubMed 38726892
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
- ClinicalTrials.gov ID
- NCT01361035
- Acronym / sponsor ID
- RWJF-63523
- Conditions
- Cervical Cancer, Breast Cancer, Colorectal Cancer
- Keywords
- health literacy, cancer screening, doctor-patient communication, standardized patient, continuing medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Tulane University School of MedicineUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jun 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 May 2011 (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.
What's the purpose of this study? This 4-year study is designed: (1) to teach primary care physicians how to recognize low health literacy patients and effectively counsel them on cancer screening using risk communication and shared decision making and (2) to assess the impact of training on changes in physician communication behavior and changes in low health literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis that physician training in cancer screening guidelines, health literacy, and communication skills will improve provider-patient interactions during encounters dealing with preventive health maintenance especially cancer screening.
How will the proposed study be implemented? Thirty-two physicians in the New Orleans metropolitan area will be recruited and randomly assigned to one of two groups. The unit of randomization will be the health care organization or clinic. The intervention group will receive training in health literacy, cancer screening, risk communication and shared decision-making. The control group will not receive communication training until the end of the study. Physicians in both groups will undergo three clinic visits with standardized patients (actors trained to portray real patients; mystery shoppers) but they will not be aware that they are conducting visits with actors. The visits will occur at study enrollment and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate the physicians' communication skills. Each physician assigned to the intervention group will receive verbal feedback on communication skills from the standardized patients and complete a web-based tutorial. Physicians in the control group will not have access to the web-based tutorial until the end of the study.
For each physician, 10-15 patients with limited health literacy will be recruited to the study. Each patient will rate his/her perceived involvement with care and global satisfaction with care at study enrollment and annually for three years. Age and gender-appropriate referral rates for breast, cervical and colorectal cancer screening and patients' receipt of such screening will be assessed annually for three years. All study physicians, regardless of group assignment, will receive performance feedback (report cards) on their cancer screening rates among low health literacy patients in their clinic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No communication training | No intervention | –Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making |
| Cancer risk ommunication skills training | Other | Other: Cancer risk communication skills trainingPhysicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physician
- Physicians who practice at these clinic sites at least one half day per week are eligible to participate in this study.
- Patient
- Eligible patients include men and women age 40 to 75, individuals enrolled in the clinic practice for at least one year, and individuals identified as having low or inadequate health literacy via the Rapid Estimate of Adult Literacy in Medicine.
Key exclusion criteria (4 listed)
- Physician
- Any provider planning to leave before the end of 12 months will be excluded.
- Patient
- Patients will be excluded if they plan to change primary care provider or site of health plan, have resided in the United States for less than five years, or do not speak English
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 |
|---|---|---|
| Cancer risk communication skills trainingIntervention physicians receive training in cancer risk communication and shared decision making (SDM). At the end of each visit with intervention physicians, standardized patients (SPs) reveal themselves as actors and give structured verbal feedback. After baseline SP visits, each intervention physician undergoes academic detailing with a communication expert. Intervention physicians are directed to a web-based communication skills tutorial where SP ratings are hyperlinked to key references for supplemental reading. Both study groups will receive annual reports detailing their patients' cancer screening status and aggregate ratings of their communication style. | Other | Cancer risk ommunication skills training |
Primary outcome
Change in cervical, breast and colorectal cancer screening rates
Time frame: 0, 12, 24 months
Cervical/Breast/Colorectal cancer screening rates will be measured at baseline and annually for 2 years to assess whether screening rates improve over time
1 secondary outcome
Change in standardized patient ratings of physician communication behaviors
Time frame: 0, 6, 12 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 10 Mar 2017.
- Background: PubMed 20352506Price-Haywood EG, Roth KG, Shelby K, Cooper LA. Cancer risk communication with low health literacy patients: a continuing medical education program. J Gen Intern Med. 2010 May;25 Suppl 2(Suppl 2):S126-9. doi: 10.1007/s11606-009-1211-6.
- Results publication: PubMed 24590734Price-Haywood EG, Harden-Barrios J, Cooper LA. Comparative effectiveness of audit-feedback versus additional physician communication training to improve cancer screening for patients with limited health literacy. J Gen Intern Med. 2014 Aug;29(8):1113-21. doi: 10.1007/s11606-014-2782-4. Epub 2014 Feb 4.
- Derived from this study: PubMed 38726892Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.
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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.
Eboni Price-Haywood, MD, MPH principal investigator
Tulane University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer risk communication skills training in people with Cervical Cancer and Breast Cancer, run by Tulane University School of Medicine at 5 sites 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 4 inclusion and 4 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Change in cervical, breast and colorectal cancer screening rates (time frame: 0, 12, 24 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 NCT01361035, which also lists 3 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 10 Mar 2017.