An interventional study of Usual Care and Web-based decision aid in Breast Cancer Stage 0, Breast Cancer Stage I and Breast Cancer Stage II, sponsored by Alliance for Clinical Trials in Oncology. Completed at 58 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Alliance for Clinical Trials in Oncology · Not applicable, Interventional, and Health services research
This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.
The primary and secondary objectives of the study:
PRIMARY OBJECTIVES:
I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.
II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.
SECONDARY OBJECTIVES:
I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.
Trial Design:
OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks.
ARM I: usual care
ARM II: decision aid intervention
The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.
190 studies on the registry are indexed under Breast Carcinoma In Situ; 25 are open to participants now.
This study's enrollment of 627 is above the median of 80 across 144 interventional studies indexed under Breast Carcinoma In Situ.
Browse Breast Carcinoma In Situ studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Prior to institutional crossover, participants receive care as per usual care.
Other: Usual Care
Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
Other: Usual Care · Other: Web-based decision aid
Usual Care
Web-based decision aid received prior to the surgical consultation
Patient Power: Self-efficacy in Patient Physician Interactions
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
Time frame: 3 weeks
Patient Power: Active Patient Participation
Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
Time frame: 1 day
Patient Knowledge
Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.
Time frame: Up to 3 weeks
Percentage of Concordant Between Surgery Received and Patient Treatment Preference
This binary outcome indicates whether the surgery received (mastectomy or lumpectomy) was concordant with the patient's treatment preference. Patient's goals/concerns (keep the breast, remove the breast for peace of mind, avoid radiation), rated from 0 (not at all important) to 10 (extremely important), and treatment preference (lumpectomy only, lumpectomy and radiation, mastectomy, other surgery, or not sure) are measured with the Decision Quality Instrument (DQI)-Breast Surgery survey, completed within 3 weeks post-consultation. Concordance is derived using the method of Sepucha et al. (2012): (1) estimate a predicted probability (pp) of surgery preference from a multivariable logistic regression model with patient's goals/concerns and stage as independent variables; (2) classify patients as concordant if pp \>= 0.5 and mastectomy was received, or pp \< 0.5 and lumpectomy was received; and (3) calculate the percentage of concordant.
Time frame: Up to 3 weeks
A total of 627 participants were enrolled. Five-hundred and ninety-eight patients (265 UC, 333 DA) were enrolled between June 2019 to December 2021 with 576 (265 UC, 311 DA) during stepped wedge design and 22 extended enrollment beyond Wave 7 (all DA). Twenty-nine surgeons were enrolled between April 2019 to October 2021 with the majority enrolled at the start of the study, while a few additional surgeons were enrolled as they joined the clinic.
| Milestone | Site 1 and 2 | Sites 3 and 4 | Sites 5 and 6 | Sites 7 and 8 | Sites 9 and 10 | Surgeons |
|---|---|---|---|---|---|---|
| Started | 26 | 54 | 34 | 74 | 77 | 28 |
| Completed | 26 | 51 | 32 | 68 | 76 | 26 |
| Not completed | 0 | 3 | 2 | 6 | 1 | 2 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Treatment goals changed due to metastatic disease | 0 | 0 | 2 | 0 | 1 | 0 |
| Withdrew: Transferred care/moved out of state, limited information on chart review | 0 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: No treatment or declined surgery | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: No surgery but had lymph node dissection instead | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: No surgery since patient had a good response to endocrine therapy | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Ineligible | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Other: staff turnover | 0 | 0 | 0 | 0 | 0 | 2 |
| Milestone | Site 1 and 2 | Sites 3 and 4 | Sites 5 and 6 | Sites 7 and 8 | Sites 9 and 10 | Surgeons |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 26 |
| Completed | 0 | 0 | 0 | 0 | 0 | 26 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Site 1 and 2 | Sites 3 and 4 | Sites 5 and 6 | Sites 7 and 8 | Sites 9 and 10 | Surgeons |
|---|---|---|---|---|---|---|
| Started | 124 | 109 | 32 | 32 | 14 | 27 |
| Completed | 118 | 101 | 31 | 25 | 14 | 27 |
| Not completed | 6 | 8 | 1 | 7 | 0 | 0 |
| Milestone | Site 1 and 2 | Sites 3 and 4 | Sites 5 and 6 | Sites 7 and 8 | Sites 9 and 10 | Surgeons |
|---|---|---|---|---|---|---|
| Started | 0 | 16 | 0 | 0 | 6 | 18 |
| Completed | 0 | 12 | 0 | 0 | 6 | 18 |
| Not completed | 0 | 4 | 0 | 0 | 0 | 0 |
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
| score on a scale | UC (Usual Care) | DA (Decision Aid Intervention) |
|---|---|---|
| Patient Power: Self-efficacy in Patient Physician Interactions | 22 (7 to 25) | 22 (5 to 25) |
Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
| count of patient communicative behaviors | UC (Usual Care) | DA (Decision Aid Intervention) |
|---|---|---|
| Patient Power: Active Patient Participation | 17.5 (0 to 114) | 19 (0 to 112) |
Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.
| score on a scale | UC (Usual Care) | DA (Decision Aid Intervention) |
|---|---|---|
| Patient Knowledge | 66.1 ± 21.8 | 69.6 ± 21.4 |
This binary outcome indicates whether the surgery received (mastectomy or lumpectomy) was concordant with the patient's treatment preference. Patient's goals/concerns (keep the breast, remove the breast for peace of mind, avoid radiation), rated from 0 (not at all important) to 10 (extremely important), and treatment preference (lumpectomy only, lumpectomy and radiation, mastectomy, other surgery, or not sure) are measured with the Decision Quality Instrument (DQI)-Breast Surgery survey, completed within 3 weeks post-consultation. Concordance is derived using the method of Sepucha et al. (2012): (1) estimate a predicted probability (pp) of surgery preference from a multivariable logistic regression model with patient's goals/concerns and stage as independent variables; (2) classify patients as concordant if pp \>= 0.5 and mastectomy was received, or pp \< 0.5 and lumpectomy was received; and (3) calculate the percentage of concordant.
| Percentage of Participants | UC (Usual Care) | DA (Decision Aid Intervention) |
|---|---|---|
| Percentage of Concordant Between Surgery Received and Patient Treatment Preference | 78.3 | 71.4 |
Collected over 827 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UC (Usual Care) | 1/264 (0.4%) | — | — |
| DA (Decision Aid Intervention) | 1/309 (0.3%) | — | — |
All stepped-wedge design participants excluding 1 ineligible in UC and 2 refused follow-up at baseline in DA; all extended enrollment beyond wave 7-DA and all surgeons.
| Age, Continuous(years) | UC (Usual Care) | DA (Decision Aid Intervention) | Extended Enrollment Beyond Wave 7-DA (Decision Aid Intervention) | Surgeons | Total |
|---|---|---|---|---|---|
| Median | 59 (30 to 87) | 61 (27 to 90) | 63.5 (32 to 84) | — | 61 (27 to 90) |
| Sex: Female, Male(Participants) | UC (Usual Care) | DA (Decision Aid Intervention) | Extended Enrollment Beyond Wave 7-DA (Decision Aid Intervention) | Surgeons | Total |
|---|---|---|---|---|---|
| Female | 264 | 309 | 22 | — | 595 |
| Male | 0 | 0 | 0 | — | 0 |
| Race/Ethnicity, Customized(Participants) | UC (Usual Care) | DA (Decision Aid Intervention) | Extended Enrollment Beyond Wave 7-DA (Decision Aid Intervention) | Surgeons | Total |
|---|---|---|---|---|---|
| Race — White | 169 | 207 | 16 | 18 | 410 |
| Race — Black | 60 | 62 | 6 | 0 | 128 |
| Race — Other | 35 | 40 | 0 | 11 | 86 |
| Socioeconomic Disadvantage(Participants) | UC (Usual Care) | DA (Decision Aid Intervention) | Extended Enrollment Beyond Wave 7-DA (Decision Aid Intervention) | Surgeons | Total |
|---|---|---|---|---|---|
| Yes | 73 | 59 | 6 | — | 138 |
| No | 191 | 250 | 16 | — | 457 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 6 to 12 months following article publication.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Data sharing details ↗ · www.allianceforclinicaltrialsinoncology.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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