Breast Cancer Stage 0NCT03766009
Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
A study testing Web-based decision aid in people with Breast Cancer Stage 0 and Breast Cancer Stage I, run by Alliance for Clinical Trials in Oncology at 58 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage 0, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- Web-based decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 58 sitesin 3 countries
- Study dates
- 5 Jun 2019to 30 May 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with stage 0-III breast cancer
- Eligible patients must be planning breast surgery as a component of their definitive treatment
- Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
- Patients with hearing impairment requiring the use of an interpreter are not eligible for this study
- Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
- CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer
- INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study
- INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation
Who cannot join
None listed.
Trial locations and contacts
58 sites in 3 countries.
58 sites in 3 countries
United States56 sites
Hawaii Cancer Care - Savio
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Community Hospital of Anaconda
Anaconda, Montana, 59711
Augusta University Medical Center
Augusta, Georgia, 30912
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Medical University of South Carolina
Charleston, South Carolina, 29425
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Billings Clinic-Cody
Cody, Wyoming, 82414
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Carle on Vermilion
Danville, Illinois, 61832
Epic Care-Dublin
Dublin, California, 94568
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Saint Peter's Community Hospital
Helena, Montana, 59601
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Island Urology
Honolulu, Hawaii, 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
Kuakini Medical Center
Honolulu, Hawaii, 96817
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
Community Medical Hospital
Missoula, Montana, 59804
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, 83686
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
Bay Area Tumor Institute
Oakland, California, 94609
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864
Welch Cancer Center
Sheridan, Wyoming, 82801
Carle Cancer Center
Urbana, Illinois, 61801
The Carle Foundation Hospital
Urbana, Illinois, 61801
Epic Care Cyberknife Center
Walnut Creek, California, 94597
Puerto Rico1 site
Pan American Center for Oncology Trials LLC
San Juan, 00902
About this study
Official title: Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
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.
Read the detailed description
The primary and secondary objectives of the study:
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Breast Cancer Stage 0, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- Usual Care, Web-based decision aid
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Usual Care
Web-based decision aidOther
Web-based decision aid received prior to the surgical consultation
| Study group | Role | What they receive |
|---|---|---|
| Arm I (surgical consultation) | Active comparator | Prior to institutional crossover, participants receive care as per usual care. Receives: Other: Usual Care |
| Arm II (web-based breast cancer surgery decision aid) | Experimental | 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.. Receives: Other: Usual Care; Other: Web-based decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start5 Jun 2019
- Primary completion26 Jan 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Stage 0Studies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Institutional cross-over
- Masking
- None (open label)
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Heather B. Neuman,, MD, MS, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766009
- Sponsor's protocol ID
- A231701CD
- Other IDs
- NCI-2018-00643
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2018
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Saucke MC, Jacobson N, Chow S, McKinney G, Neuman HB. Providing information to prepare breast cancer patients for their surgical consultation: barriers and recommendations (an analysis from Alliance A231701CD). Support Care Cancer. 2026 May 14;34(6):537. doi: 10.1007/s00520-026-10726-7.
PubMed 42128956Schumacher JR, Hanlon BM, Zahrieh D, Rathouz PJ, Tucholka JL, McKinney G, Tan AD, Breuer CR, Bailey L, Higham AM, Wecsler JS, Arnold AH, Froix AJ, Dull S, Abbott AM, Fine SG, McGuire KP, Seydel AS, McNamara P, Chow S, Neuman HB. Impact of a Web-Based Decision Aid on Socioeconomically Disadvantaged Patients' Engagement in Breast Surgery Decision-Making: Stepped-Wedge Clinical Trial (Alliance-A231701CD). Ann Surg Oncol. 2025 Aug;32(8):5540-5550. doi: 10.1245/s10434-025-17452-0. Epub 2025 May 17.
PubMed 40382452Saucke MC, Jacobson N, McKinney G, Neuman HB. Role of the Surgeon in De-Escalating Emotion During a Breast Cancer Surgery Consultation: A Qualitative Study of Patients' Experiences in Alliance A231701CD. Ann Surg Oncol. 2024 Dec;31(13):8873-8881. doi: 10.1245/s10434-024-16156-1. Epub 2024 Sep 25.
PubMed 39320397Zahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019.
PubMed 37923529Schumacher JR, Zahrieh D, Chow S, Taylor J, Wills R, Hanlon BM, Rathouz PJ, Tucholka JL, Neuman HB. Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial. BMJ Open. 2022 Nov 17;12(11):e063895. doi: 10.1136/bmjopen-2022-063895.
PubMed 36396308