Testing a Mammography Decision Intervention in a Rural Setting

NCT06522568 | Recruiting

• 1 other identifier: STUDY02002381
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention. This will be accomplished through two aims: (1) Refine, with community partner input, a clinical trial protocol to optimize engagement among patients and primary care providers (PCPs) practicing in rural settings. In consultation with patients, PCPs, and informatics experts, the study team will refine site selection, randomization, patient and PCP recruitment, and data collection protocols to meet the needs of the rural health care delivery system and participants. The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners. (2) Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence. The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit, relative to usual care. Implementing the trial in two phases (n=15 each) will systematically identify barriers and facilitators to trial participation to refine protocols. Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives.

Conditions

Breast Cancer

Keywords

Screening

Outcome Measures

Primary Outcomes (1)

• Intervention acceptability

  The acceptability e-scale is a 6-item measure for electronically-delivered interventions, where higher scores indicate greater acceptability. Scores range from 6-30.

  within one day of completing the intervention

Secondary Outcomes (2)

• Recruitment feasibility

  4 weeks

• Retention feasibility

  8 weeks

Other Outcomes (5)

• Knowledge

  enrollment and within one day of completing the intervention

• Decisional Quality

  enrollment, within one day of completing the intervention, within one day of completing a clinical visit

• Screening Intentions

  enrollment, within one day of completing the intervention, within one day of completing a clinical visit

Study Arms (3)

Usual Care

NO INTERVENTION

Usual care.

MyMammogram

EXPERIMENTAL

Patient uses MyMammogram prior to appointment.

Behavioral: MyMammogram

MyMammogram plus provider communication

EXPERIMENTAL

Patient uses MyMammogram prior to appointment. Provider receives a summary from MyMammogram prior to appointment.

Behavioral: MyMammogram; Other: Provider communication

Interventions

MyMammogram BEHAVIORAL

An online breast cancer screening decision aid

MyMammogram; MyMammogram plus provider communication

Provider communication OTHER

Provider will be provided with information from MyMammogram that includes patient's breast cancer risk and preferences for mammograms prior to the appointment

MyMammogram plus provider communication

Eligibility Criteria

• Age: 39 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females
• Aged 39-49
• Upcoming appointment with a participating primary care provider (within 4 weeks)
• English or Spanish-speaking

You may not qualify if:

• Personal history of breast cancer (including lobular carcinoma in situ and ductal carcinoma in situ or atypical hyperplasia)
• Mammogram in the prior 12 months

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Trustees of Dartmouth College: collaborator

Study Sites (1)

Cheshire Medical Center

Keene, New Hampshire, 03431, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Christine M Gunn, PhD

CONTACT

603-646-5430; Christine.M.Gunn@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Geisel School of Medicine, Dartmouth; Professor of Surgery, Geisel School of Medicine, Dartmouth

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)