Breast CancerNCT02296177
Evidence Based Dissemination for Mammography Adherence in Safety Net Communities
A study testing Peace of Mind Program in people with Breast Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Regular screening, early diagnosis, and timely treatment initiation have been shown to reduce breast cancer morbidity and mortality. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Peace of Mind Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,448 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Mar 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Underserved as defined by income <=200% of the federal poverty level for a family of four
- Uninsured
- In need of mammography screening; has received clinical breast exam and referral to screening
- Has upcoming screening appointment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center Houston
Houston, Texas, 77030
About this study
Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Regular screening, early diagnosis, and timely treatment initiation have been shown to reduce breast cancer morbidity and mortality. However, disparities continue to exist across the breast cancer continuum for underserved women, particularly minority women. The reduction of disparities in breast cancer outcomes is a major goal of Healthy People 2020 and the National Cancer Institute. However, the preventable burden of late stage breast cancer will continue until the investigators close the gap between what is known about prevention and what is implemented in the community. Although many sources of information exist about theory and [theory-] and evidence-based interventions (EBIs) to promote mammography screening, their adoption and use in the community has been limited and haphazard at best.
Read the detailed description
In order to effectively reach underserved women and reduce breast cancer disparities, D\&I efforts should target the healthcare delivery system where these women receive service - the so called "safety net". Within the safety net, federally qualified health centers (FQHCs), provide comprehensive primary health care services for underserved communities regardless of ability to pay, including mammography screening. Our team has successfully pilot tested a National Cancer Institute research tested intervention program (RTIP) with underserved women and were able to reduce no-show rates from 44% to 19%. In order to accelerate the adoption and implementation of our EBI within the safety net, the investigators will use a two-step approach based on the consolidated framework for implementation research (CFIR), and intervention mapping. The investigators will actively disseminate the EBI through a unique breast health collaborative with a wide membership of FQHCs, support implementation through training and evaluate the adoption, implementation, sustainment and effectiveness of the EBI. The investigators will use a clinic clustered stepped wedge design for implementation in FQHCs.
- Conditions
- Breast Cancer
- Being tested
- Peace of Mind Program
- Keywords
- evidence-based intervention, mammography, underserved population
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peace of Mind ProgramBehavioural
The Peace of Mind Program (PMP) is a telephone counseling program based on the Transtheoretical Model of Change, with messages matched to readiness (assessed with a stage of change question)and barriers identified by women who are non-adherent to mammography. The program telephone protocol guides counselors to assess a woman's readiness to be screened and counsel her through barriers to increase appointment keeping.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive the standard practice of care related to mammography phone call reminders. If a clinic currently conducts reminders, they will receive that standard call. If no reminders are done, then they will not receive a call during the control period. |
| Intervention | Active comparator | The intervention group will receive a reminder call about their upcoming appointment that assesses their intent to attend the appointment and counsels them through barriers to attendance. The call is conducted by a trained patient navigator using an adapted NCI RTIP to increase mammography appointment adherence. Receives: Behavioral: Peace of Mind Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammography Appointment Adherence
Appointment attendance will be taken from the electronic health record for both control and intervention patients
Measured: 12 months
Secondary outcomes (1)
Cancellations or rescheduled appointments
Patients who cancelled and rescheduled will be taken from the electronic health record for both control and intervention patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJul 2015
- Primary completionMar 2018
- Study completionMar 2018
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4,448 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Linda Highfield, The University of Texas Health Science Center, Houston
- Investigators
- Linda Highfield, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296177
- Sponsor's protocol ID
- HSC-SPH-14-0269
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2014
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holcomb J, Rajan SS, Ferguson GM, Sun J, Walton GH, Highfield L. Implementation of an Evidence-Based Intervention with Safety Net Clinics to Improve Mammography Appointment Adherence Among Underserved Women. J Cancer Educ. 2023 Feb;38(1):309-318. doi: 10.1007/s13187-021-02116-w. Epub 2021 Nov 25.
PubMed 34822118Highfield L, Valerio MA, Fernandez ME, Eldridge-Bartholomew LK. Development of an Implementation Intervention Using Intervention Mapping to Increase Mammography Among Low Income Women. Front Public Health. 2018 Oct 26;6:300. doi: 10.3389/fpubh.2018.00300. eCollection 2018.
PubMed 30416992Highfield L, Rajan SS, Valerio MA, Walton G, Fernandez ME, Bartholomew LK. A non-randomized controlled stepped wedge trial to evaluate the effectiveness of a multi-level mammography intervention in improving appointment adherence in underserved women. Implement Sci. 2015 Oct 14;10:143. doi: 10.1186/s13012-015-0334-x.
PubMed 26464110
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Dissemination for Mammography Adherence in Safety Net Communities
- ClinicalTrials.gov ID
- NCT02296177
- Acronym / sponsor ID
- HSC-SPH-14-0269
- Conditions
- Breast Cancer
- Keywords
- evidence-based intervention, mammography, underserved population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,448 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jul 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Nov 2014 (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.
Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Regular screening, early diagnosis, and timely treatment initiation have been shown to reduce breast cancer morbidity and mortality. However, disparities continue to exist across the breast cancer continuum for underserved women, particularly minority women. The reduction of disparities in breast cancer outcomes is a major goal of Healthy People 2020 and the National Cancer Institute. However, the preventable burden of late stage breast cancer will continue until the investigators close the gap between what is known about prevention and what is implemented in the community. Although many sources of information exist about theory and [theory-] and evidence-based interventions (EBIs) to promote mammography screening, their adoption and use in the community has been limited and haphazard at best.
Detailed description
In order to effectively reach underserved women and reduce breast cancer disparities, D\&I efforts should target the healthcare delivery system where these women receive service - the so called "safety net". Within the safety net, federally qualified health centers (FQHCs), provide comprehensive primary health care services for underserved communities regardless of ability to pay, including mammography screening. Our team has successfully pilot tested a National Cancer Institute research tested intervention program (RTIP) with underserved women and were able to reduce no-show rates from 44% to 19%. In order to accelerate the adoption and implementation of our EBI within the safety net, the investigators will use a two-step approach based on the consolidated framework for implementation research (CFIR), and intervention mapping. The investigators will actively disseminate the EBI through a unique breast health collaborative with a wide membership of FQHCs, support implementation through training and evaluate the adoption, implementation, sustainment and effectiveness of the EBI. The investigators will use a clinic clustered stepped wedge design for implementation in FQHCs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive the standard practice of care related to mammography phone call reminders. If a clinic currently conducts reminders, they will receive that standard call. If no reminders are done, then they will not receive a call during the control period. |
| Intervention | Active comparator | Behavioral: Peace of Mind ProgramThe intervention group will receive a reminder call about their upcoming appointment that assesses their intent to attend the appointment and counsels them through barriers to attendance. The call is conducted by a trained patient navigator using an adapted NCI RTIP to increase mammography appointment adherence. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Underserved as defined by income <=200% of the federal poverty level for a family of four
- Uninsured
- In need of mammography screening; has received clinical breast exam and referral to screening
- Has upcoming screening appointment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Peace of Mind ProgramThe Peace of Mind Program (PMP) is a telephone counseling program based on the Transtheoretical Model of Change, with messages matched to readiness (assessed with a stage of change question)and barriers identified by women who are non-adherent to mammography. The program telephone protocol guides counselors to assess a woman's readiness to be screened and counsel her through barriers to increase appointment keeping. | Behavioural | Intervention |
Primary outcome
Mammography Appointment Adherence
Time frame: 12 months
Appointment attendance will be taken from the electronic health record for both control and intervention patients
1 secondary outcome
Cancellations or rescheduled appointments
Time frame: 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 8 Dec 2023.
- Derived from this study: PubMed 34822118Holcomb J, Rajan SS, Ferguson GM, Sun J, Walton GH, Highfield L. Implementation of an Evidence-Based Intervention with Safety Net Clinics to Improve Mammography Appointment Adherence Among Underserved Women. J Cancer Educ. 2023 Feb;38(1):309-318. doi: 10.1007/s13187-021-02116-w. Epub 2021 Nov 25.
- Derived from this study: PubMed 30416992Highfield L, Valerio MA, Fernandez ME, Eldridge-Bartholomew LK. Development of an Implementation Intervention Using Intervention Mapping to Increase Mammography Among Low Income Women. Front Public Health. 2018 Oct 26;6:300. doi: 10.3389/fpubh.2018.00300. eCollection 2018.
- Derived from this study: PubMed 26464110Highfield L, Rajan SS, Valerio MA, Walton G, Fernandez ME, Bartholomew LK. A non-randomized controlled stepped wedge trial to evaluate the effectiveness of a multi-level mammography intervention in improving appointment adherence in underserved women. Implement Sci. 2015 Oct 14;10:143. doi: 10.1186/s13012-015-0334-x.
- Individual participant dataSharing planned: No
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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.
Linda Highfield principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peace of Mind Program in people with Breast Cancer, run by The University of Texas Health Science Center, Houston 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 4 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 8 Dec 2023. 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?
Mammography Appointment Adherence (time frame: 12 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 NCT02296177, 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 8 Dec 2023.