Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05526872
Other study ID # STUDY00004618
Secondary ID NCI-2022-06810ST
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2022
Est. completion date June 1, 2024

Study information

Verified date June 2024
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial evaluates the patient reminders and self-referrals via online patient portals and text messaging (PReVenT) intervention for improving adherence to breast cancer screening. Though no doctor referral is required for mammography, adherence to screening mammograms remains low. Barriers to screening mammography can include things like forgetfulness, low motivation, high cost, or lack of knowledge. Patient reminders and self-scheduling assistance may overcome some of these barriers by increasing patients' awareness, motivating them to schedule their mammogram, and improving access by removing the need for a healthcare provider to order the exam. The PReVenT intervention uses online and text-message based patient-reminders and self-referral assistance to increase adherence to breast cancer screening.


Description:

PRIMARY OBJECTIVES; I. Compare the screening mammogram (SM) completion rates between PReVenT and enhanced usual care (EUC) arms at 6 months. II. Describe patient's experience with the PReVenT intervention using mixed methods stratified by completion of SM. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive usual care as well as a portal message reminder to schedule a SM and a callback link if they need assistance. Participants who have not or do not schedule their SM at the time of the first reminder receive a reminder text-message one week later with a link to receive assistance with scheduling. ARM II: Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating. After completion of study, patients are followed up at 6 months.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date June 1, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 74 Years
Eligibility Inclusion Criteria: - Women aged 50-74 years - Active online patient portal account - Mobile phone number listed in the electronic medical record (EMR) - At least one primary care visit in our healthcare system between 2015 and 2021 - No screening mammography performed in our healthcare system in the last 2 years Exclusion Criteria: - Because of limited research team and patient portal language at this time, non-English speaking patient will be excluded - Personal history of breast cancer or prior mastectomy - Participants who already have an upcoming SM scheduled within or outside of Emory Healthcare - Patients who had a screening mammography at an outside facility within the prior 2 years - Patients with severe comorbidities at the time of the study (in palliative care or hospitalized at the time of the study) - Participants who are cognitively impaired or have with history of Alzheimer's disease or dementia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Best Practice
Receive usual care
Behavioral:
Health Education
Receive educational materials
Other:
Interview
Ancillary studies
Planned Notification
Receive planned reminders to schedule mammogram
Survey Administration
Ancillary studies

Locations

Country Name City State
United States Emory University/Winship Cancer Institute Atlanta Georgia

Sponsors (3)

Lead Sponsor Collaborator
Emory University National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion of Screening Mammogram-Adherence Rate Assessed with self-reported surveys and electronic medical record data extraction. Will use chi-square tests and/or two-sample Z-tests for proportions to compare adherence rates between study arms. Fisher's exact test will be considered where necessary. Within 6 months after enrollment
Primary Completion of Screening Mammogram-Regression Modeling Assessed with self-reported surveys and electronic medical record data extraction.Will perform a multivariable logistic regression modeling to compare screening mammogram completion rates between the intervention and control arms while controlling for prior adherence behavior and sociodemographic variables. Within 6 months after enrollment
Primary Patient Satisfaction-Qualitative Will use a mixed-methods approach using surveys and qualitative interviews to evaluate patient satisfaction with the intervention features, online portal and short message service usability i.e., opening the portal message, clicking the embedded link, and replying to the short message service. the patient satisfaction survey measure the following:
I prefer to get care in person or over the phone instead of using online patient portals, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable. I rarely use online patient portals because I hardly ever need Emory Healthcare services, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.It was difficult to register for Emory's online patient portal, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.
At 6 months
Primary Patient Satisfaction-Quantitative Will use a mixed-methods approach using chi-square tests and/or two-sample Z-tests for proportions to compare adherence rates between study arms. Fisher's exact test will be considered where necessary. At 6 months
Primary Assistance with Self-Referral Scheduling Will use a mixed-methods approach using surveys and qualitative interviews. Arm I patients will receive a single portal message reminder followed by a single text message reminder with an embedded link to receive a callback to get assistance with self-referral screening mammogram scheduling.The survey measures the following:I only became aware that I was due for screening mammography after I received Emory's online patient portal reminder, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.I only became aware that I was due for screening mammography after I received Emory's text message reminder, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.I was more willing to schedule a screening mammography after receiving Emory's online patient portal reminder, where1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable. At 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT04996316 - MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
Enrolling by invitation NCT05558917 - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery N/A
Not yet recruiting NCT05178498 - Impact of Dietary Inflammatory Potential on Breast Cancer Risk
Recruiting NCT05544123 - The Treatment Situation of Chinese County Population With Breast Cancer
Withdrawn NCT05191004 - Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC Phase 1/Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Recruiting NCT01462903 - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors Phase 1
Completed NCT01422408 - Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy Phase 2
Terminated NCT00770354 - Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer Phase 2
Terminated NCT02810873 - Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer N/A
Withdrawn NCT03185871 - Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses Phase 2
Completed NCT02983279 - Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer N/A
Active, not recruiting NCT02194387 - Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members N/A
Recruiting NCT05406232 - Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Recruiting NCT03408353 - Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
Completed NCT01641068 - Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms N/A
Withdrawn NCT04190433 - Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial Phase 2
Recruiting NCT04799535 - Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A
Not yet recruiting NCT05941520 - Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer Phase 2