A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening

NCT ID: NCT05526872

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-06-01

Brief 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.

Detailed 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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Arm I (PReVenT intervention)

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.

Group Type: EXPERIMENTAL

Best Practice

Intervention Type: OTHER

Receive usual care

Interview

Intervention Type: OTHER

Ancillary studies

Planned Notification

Intervention Type: OTHER

Receive planned reminders to schedule mammogram

Survey Administration

Intervention Type: OTHER

Ancillary studies

Arm II (enhanced usual care)

Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive usual care

Health Education

Intervention Type: BEHAVIORAL

Receive educational materials

Interview

Intervention Type: OTHER

Ancillary studies

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive usual care

Intervention Type: OTHER

Health Education

Receive educational materials

Intervention Type: BEHAVIORAL

Interview

Ancillary studies

Intervention Type: OTHER

Planned Notification

Receive planned reminders to schedule mammogram

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; PlannedNotification

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Patricia Balthazar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Balthazar, MD,CIIP

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2022-06810

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00004618

Identifier Type: OTHER

Identifier Source: secondary_id

RAD5676-22

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004618

Identifier Type: -

Identifier Source: org_study_id