Mammogram Mail- and Phone-based Interventions

Breast Cancer Clinical Trial

Official title:

Randomized Comparison of Mail- and Phone-based Interventions Promoting Mammogram Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853848
• Other study ID #: 2022-0369
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Geisinger Clinic
• Contact: Amir Goren, PhD
• Phone: 5702144395
• Email: agoren[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project aims to evaluate four different versions and modalities of interventions encouraging mammogram screening among all eligible women due or overdue for screening. The evaluation will compare among the following forms of outreach to help determine whether (a) live calls are more effective at increasing mammogram screening than other forms of outreach and (b) each form of outreach is more effective than no outreach: (1) a postcard, (2) a letter, (3) an auto-dialer phone message, and (4) a live call from a care gaps team. The interventions will be rolled out over many months, allowing for comparisons of effectiveness against those who have not yet been contacted.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17650
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 51 Years to 74 Years

Eligibility

Inclusion Criteria:

• Female Geisinger Health Plan members between ages 52 and 74 as of December 31, 2023

• Overdue for annual mammogram

• Continuously enrolled with the Geisinger Health Plan as of October 1, 2021

• Can be contacted via both phone and mail

Exclusion Criteria:

• Geisinger Health Plan members on a do-not-contact list

• Had a mammogram as of October 1, 2021

• In hospice, using hospice services, or receiving palliative care as of January 1, 2023

• Medicare members 66 years of age or above at time of outreach, who are institutionalized or have both frailty and advanced illness

• Had a bilateral mastectomy at any time

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Postcard
Postcard with phone number to call for help scheduling a mammogram.
• Letter
Letter with phone number to call for help scheduling a mammogram.
• Auto-dialer
Auto-dialer with option to press button for help scheduling a mammogram.
• Live call
Live call offering help scheduling a mammogram.

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mammogram completed	Record of completed mammogram (yes/no), for comparing across postcards, letters, and auto-dialer messages	In the 180 days following the patient's intervention send date
Other	Breast malignancy risk detected	Record of high malignancy risk (yes/no), for comparing across different modalities of outreach	In the 210 days following the patient's intervention send date
Other	Mammogram appointment scheduled	Appointment scheduled for mammogram, among patients visiting Geisinger clinics (yes/no)	In the 30 days following the patient's intervention send date
Primary	Mammogram completed	Record of completed mammogram (yes/no), for comparing postcards, letters, and auto-dialer messages with live calls	In the 180 days following the patient's intervention send date
Primary	Mammogram completed	Record of completed mammogram (yes/no), for comparing postcards, letters, auto-dialer messages, and live calls with controls	In the 120 days following the patient's intervention send date