Testing a Mammography Decision Intervention in a Rural Setting

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age39-49
SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females

Aged 39-49

Upcoming appointment with a participating primary care provider (within 4 weeks)

English or Spanish-speaking

Disqualifiers

Personal history of breast cancer (including lobular carcinoma in situ and ductal carcinoma in situ or atypical hyperplasia)

Mammogram in the prior 12 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • MyMammogram

    Behavioral

    An online breast cancer screening decision aid

  • Provider communication

    Other intervention

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

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: MyMammogramExperimental treatment 1 intervention
Group C: MyMammogram plus provider communicationExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
within one day of completing the intervention

Secondary outcomes

1

Recruitment feasibility

Measured as the proportion of eligible participants who receive an initial outreach letter and complete the consent process and enroll prior to their clinical visit.

Time frame
4 weeks
2

Retention feasibility

Proportion of participants enrolled who complete all study survey time points, reported per trial arm

Time frame
8 weeks

Other outcomes

1

Knowledge

10-item measure of breast cancer and screening knowledge that is summed for a score from 0-10 (0 indicates lower knowledge, 10 indicates higher knowledge).

Time frame
enrollment and within one day of completing the intervention
2

Decisional Quality

Decisional Quality is measured using the Decisional Conflict Scale for Low Literacy, a 10-item measure. Scores Range 0-100. Lower scores indicate better decisional quality (lower conflict).

Time frame
enrollment, within one day of completing the intervention, within one day of completing a clinical visit
3

Screening Intentions

Screening intentions are using two methods. 1) As the likelihood of obtaining a mammogram in the next year (5-point Likert scale); and 2) Using 2 items to measure age at which someone intends to begin screening (40, 45, 50, other) and interval (annual, biennial, other).

Time frame
enrollment, within one day of completing the intervention, within one day of completing a clinical visit
4

Shared Decision-Making

Shared Decision Making will be assessed with the 3-item, validated CollaboRATE measure. Scored 0-100 (higher scores indicate more shared decision-making).

Time frame
within one day of completing a clinical visit

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Trustees of Dartmouth College

Collaborator