Breast CancerNCT05275361
Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women
A study testing Social Contact Reminder in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Eliminating racial disparities in breast cancer is a top public health priority. African American (AA) women often present with more advanced and aggressive disease at the time of diagnosis and are more likely to die from breast cancer than any other racial/ethnic group in the United States. 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?
- Social Contact Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 30 Jun 2022
- 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
- Female
- African American
- At least 40 years old
- Scheduled for a screening mammogram within 3 months following initiation of the study
- Willing and able to provide contact information for two adult social contacts (friends or family members)
- At least 18 years old
- Selected by the patient as someone (family member or friend) who would be able to support her in keeping her mammogram appointment
Who cannot join
- -Prior history of breast cancer
- -Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Study Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women
Eliminating racial disparities in breast cancer is a top public health priority. African American (AA) women often present with more advanced and aggressive disease at the time of diagnosis and are more likely to die from breast cancer than any other racial/ethnic group in the United States. Mammogram screening significantly reduces breast cancer mortality by diagnosing cancer at an earlier stage where treatments are more effective. While some AA women do not schedule screening mammograms as recommended by current guidelines, others do not show up for their exams after scheduling them (no-shows). No-shows to cancer screening appointments impose an enormous strain on our limited healthcare resources with negative impact on other patients who could have secured earlier appointments, loss of revenue for hospitals or clinics serving underserved populations and delays in diagnoses and treatment for those who do not have screening. The investigators identified a high no-show rate for screening mammograms at our hospital. AA women were almost three times more likely to no-show for their mammograms compared to White women. Patient's social networks plan an important role in health promotion. In this study, we will pilot an intervention involving patient's social contacts (family, friends, neighbors, etc.) as healthcare facilitators to improve appointment attendance. The investigators seek to determine whether this intervention is feasible and acceptable to patients and whether this intervention will improve attendance rates for screening mammograms among AA women at our institution. If effective, the use of a patient's social contact person as a healthcare facilitator (similar to a patient navigator) would be a readily available and inexpensive resource for other institutions to implement.
- Conditions
- Breast Cancer
- Being tested
- Social Contact Reminder
- Keywords
- Mammogram, Breast Cancer Screening, African American women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Contact ReminderBehavioural
-The social contact will remind patient about screening mammogram appointment
| Study group | Role | What they receive |
|---|---|---|
| Patient: Scheduled for mammogram | Experimental | * Will be asked to choose 2 social contacts (adult family member or friend identified by the participant as someone who could be engaged by the research team to encourage the participant to attend her mammogram appointment)
* Will receive reminder(s) from social contact about the screening mammogram appointment
* Will receive reminder from Breast Health Center about screening mammogram appointment
* Will be contacted to provide experience with the study Receives: Behavioral: Social Contact Reminder |
| Social Contact of Patient | No intervention | * Facilitate enrolled patient to complete the screening mammogram. * Will receive information about screening mammograms and resources available at the Breast Imaging Center. * Will be contacted approximately 3 days prior to the patient's mammogram appointment. * Will be contacted to provide experience with the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting patients' social contacts to serve as healthcare facilitators as measured by number of participants enrolled to the study with a social contact that agrees to participate
-The study is deemed feasible if 80 participants are enrolled to the study and further, if at least 65% of the 80 participants will have a social contact agreeing to participate
Measured: Through completion of enrollment (estimated to be 3 months)
Secondary outcomes (3)
Describe demographic characteristics of the social contacts and any associations with patient appointment attendance
-Use descriptive statistics to present the characteristics of social contacts and regression analysis to determine in association with social contact characteristics and appointment attendance.
Measured: Through mammogram appointment (estimated to be 6 months)
Rate of mammography attendance
Measured: Through mammogram appointment (estimated to be 6 months)
Using a structured survey interview, determine the percentage of patients and their social contacts who respond positively (agree or strongly agree) that the intervention helped them keep their scheduled screening mammogram appointment
-Use descriptive statistics to present response to structured interview questions.
Measured: Through mammogram appointment (estimated to be 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start18 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Sponsor
- Investigators
- Whitney Hensing, M.D., M.S., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275361
- Sponsor's protocol ID
- 202110124
- Status last verified
- Jul 2022
- First submitted
- 4 Feb 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women
- ClinicalTrials.gov ID
- NCT05275361
- Acronym / sponsor ID
- 202110124
- Conditions
- Breast Cancer
- Keywords
- Mammogram, Breast Cancer Screening, African American women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- 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.
Eliminating racial disparities in breast cancer is a top public health priority. African American (AA) women often present with more advanced and aggressive disease at the time of diagnosis and are more likely to die from breast cancer than any other racial/ethnic group in the United States. Mammogram screening significantly reduces breast cancer mortality by diagnosing cancer at an earlier stage where treatments are more effective. While some AA women do not schedule screening mammograms as recommended by current guidelines, others do not show up for their exams after scheduling them (no-shows). No-shows to cancer screening appointments impose an enormous strain on our limited healthcare resources with negative impact on other patients who could have secured earlier appointments, loss of revenue for hospitals or clinics serving underserved populations and delays in diagnoses and treatment for those who do not have screening. The investigators identified a high no-show rate for screening mammograms at our hospital. AA women were almost three times more likely to no-show for their mammograms compared to White women. Patient's social networks plan an important role in health promotion. In this study, we will pilot an intervention involving patient's social contacts (family, friends, neighbors, etc.) as healthcare facilitators to improve appointment attendance. The investigators seek to determine whether this intervention is feasible and acceptable to patients and whether this intervention will improve attendance rates for screening mammograms among AA women at our institution. If effective, the use of a patient's social contact person as a healthcare facilitator (similar to a patient navigator) would be a readily available and inexpensive resource for other institutions to implement.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient: Scheduled for mammogram | Experimental | Behavioral: Social Contact Reminder* Will be asked to choose 2 social contacts (adult family member or friend identified by the participant as someone who could be engaged by the research team to encourage the participant to attend her mammogram appointment) * Will receive reminder(s) from social contact about the screening mammogram appointment * Will receive reminder from Breast Health Center about screening mammogram appointment * Will be contacted to provide experience with the study |
| Social Contact of Patient | No intervention | –* Facilitate enrolled patient to complete the screening mammogram. * Will receive information about screening mammograms and resources available at the Breast Imaging Center. * Will be contacted approximately 3 days prior to the patient's mammogram appointment. * Will be contacted to provide experience with the study |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- African American
- At least 40 years old
- Scheduled for a screening mammogram within 3 months following initiation of the study
- Willing and able to provide contact information for two adult social contacts (friends or family members)
Key exclusion criteria (2 listed)
- -Prior history of breast cancer
- -Less than 18 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 |
|---|---|---|
| Social Contact Reminder-The social contact will remind patient about screening mammogram appointment | Behavioural | Patient: Scheduled for mammogram |
Primary outcome
Feasibility of recruiting patients' social contacts to serve as healthcare facilitators as measured by number of participants enrolled to the study with a social contact that agrees to participate
Time frame: Through completion of enrollment (estimated to be 3 months)
-The study is deemed feasible if 80 participants are enrolled to the study and further, if at least 65% of the 80 participants will have a social contact agreeing to participate
3 secondary outcomes
Describe demographic characteristics of the social contacts and any associations with patient appointment attendance
Time frame: Through mammogram appointment (estimated to be 6 months)
Rate of mammography attendance
Time frame: Through mammogram appointment (estimated to be 6 months)
Using a structured survey interview, determine the percentage of patients and their social contacts who respond positively (agree or strongly agree) that the intervention helped them keep their scheduled screening mammogram appointment
Time frame: Through mammogram appointment (estimated to be 6 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 7 Jul 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Whitney Hensing, M.D., M.S. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Contact Reminder in people with Breast Cancer, run by Washington University School of Medicine 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 7 inclusion and 2 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 7 Jul 2022. 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?
Feasibility of recruiting patients' social contacts to serve as healthcare facilitators as measured by number of participants enrolled to the study with a social contact that agrees to participate (time frame: Through completion of enrollment (estimated to be 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2022.