Clinical trial · Interventional
SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
NCT06896474CI-TRIAL-00107458SDMPOSSIBLErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Investigators aim to conduct a type 1 hybrid effectiveness-implementation surgeon-level cluster randomized clinical trial (RCT) of a multi-level intervention, a shared decision making training for surgeons plus patient decision aid vs. usual care (UC), at 7 large health systems across the U.S. to learn the intervention's effectiveness. Decision aids will be mailed and sent via patient portal and/or via email (when portal/email addresses are available) to patients before their first surgical encounter. The central hypothesis is that the novel intervention will be a key resource to support shared decision making leading to higher quality treatment decisions and as result improved care and outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shared Decision-Making Training and Decision Aid | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgeons + SDM/DA
- description
- 22 enrolled surgeon participants will be randomized and will complete: * Baseline questionnaire * Virtual 1 hour training on SDM * 3-month training follow up survey * At Month 12: 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually * End-of-study survey * At end of study 6 surgeon participants will take part in a semi-structured interview with research assistant/PI by phone, in-person, or virtually. Approximately, 153 patients and 17 caregivers will be in this arm. They will complete a survey at 1 week and 6 months. At 12 months investigators will ask 12 patients and 4 caregivers to complete a qualitative interview. At end of study investigators will ask 12 patients and 4 caregivers to complete a qualitative semi-structured interview with research assistant/PI by phone, in-person, or virtually.
- interventionNames
- Behavioral: Shared Decision-Making Training and Decision Aid
- type
- NO_INTERVENTION
- label
- Standard-of-Care
- description
- 22 enrolled surgeons will be randomized to usual care and will complete: * Baseline questionnaire * End-of-study survey * May choose to participat in End-of-study virtual 1 hour training on SDM * 3-month training follow up survey evaluating the training Approximately, 153 patients and 17 care-givers will be in this arm. They will complete a survey at 1 week and 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Surgeon Inclusion Criteria: * Non-resident surgeon \>18 years old * Cares for women \>/= 70 years at one of the recruitment practices. * Ability and willingness to provide verbal consent Aim 1 Participant Inclusion Criteria: Participants whose medical records will be followed for treatments received and survival * Biological female * aged 70 or older * first primary invasive breast cancer * clinically \</=2 cm * clinically lymph node negative * estrogen receptor positive (ER+) -HER2- * scheduled with a participating surgeon for an initial encounter. Females with ER+ breast cancer will be included regardless of their progesterone receptor (PR) status since treatment decisions are similar for ER+/PR+ and ER+/PR- women. Aim 1 Participant Inclusion Criteria: Participants whose medical records will be reviewed retrospectively for treatments received in the year before the participating surgeon completes the baseline questionnaire * Biological female * aged 70 or older * a first primary invasive breast cancer * clinically \</=2 cm * clinically lymph node negative * estrogen receptor positive(ER+) -HER2- * saw a participating surgeon for an initial encounter in the year before the surgeon completed the baseline questionnaire. Aim 2 Participant Inclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes * Biological female * aged 70 or older * first primary invasive breast cancer * clinically \</=2 cm * clinically lymph node negative * estrogen receptor positive (ER+) -HER2- * scheduled with a participating surgeon for an initial encounter. If a patient completes the baseline questionnaire and then is found to have different tumor characteristics (e.g., found to be lymph node positive during surgery), investigators plan to retain the patient in the study and ask them to complete the second survey. Primary caregiver Inclusion Criteria: * primary family, friend, or non-paid caregiver (herein referred to as caregiver) of a patient unable or unwilling to complete study questionnaires due to cognitive decline. The primary family, friend, or non-paid caregiver will be identified by the patient, self-identified, or documented as the decision maker in the medical record. * Age \>18 * English or Spanish speaking * Ability and willingness to provide verbal consent Allied health professionals (Aim 4 at the end of the trial) Inclusion Criteria: * Administrator, social worker, physician assistant, navigator, nurse or other allied health professional in breast surgery * Ability and willingness to provide verbal consent Surgeon Exclusion Criteria: * Resident surgeon * Non-surgeons * Psychiatric illness situations that would limit compliance with study requirements Aim 1 Participant Exclusion criteria: Participants whose medical records will be followed for treatments received and survival * Age \<70 * Biological males: Biological males will be excluded since the data informing the DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer. * Non English or non-Spanish speaking: Women who do not speak English or Spanish will be excluded since these women are not eligible for the DA. * History of invasive breast cancer * History ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment) * Women with Paget's disease because treatment options differ * inflammatory breast cancer because treatment options differ * Phyllodes tumor because treatment options differ. * In hospice * Surgeon not willing to participate Aim 1 Participant Exclusion Criteria: Participants whose medical records will be reviewed retrospectively for treatments received in the year before the participating surgeon completes the baseline questionnaire * Age \<70 * Biological males: Biological males will be excluded since the data informing the DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer. * Non English or non-Spanish speaking: Women who do not speak English or Spanish will be excluded since these women are not eligible for the DA. If the DA is found to be effective in English and Spanish we plan to have the DA professionally translated to other languages at the end of the trial. English and Spanish are the most common languages spoken by older women at our recruitment sites. * History of invasive breast cancer * History ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment) * Paget's disease inflammatory breast cancer * Phyllodes tumor * In hospice * Surgeon not willing to participate Aim 2 Participant Exclusion Criteria: Participants who will be included in Aim 2 participant surveys to learn patient reported outcomes * Age \<70 * Biological males: Biological males will be excluded since the data informing our DA were obtained from studies of biological females and treatment recommendations and outcomes tend to be worse for biological males with breast cancer. * Non English or non-Spanish speaking: Women who do not speak English or Spanish will be excluded since these women are not eligible for the DA. * history of invasive breast cancer * Women with history ductal carcinoma in situ treated with radiation (since these women are generally not be eligible for radiation treatment) * Paget's disease * Inflammatory breast cancer * A phyllodes tumor. * In hospice * Surgeon not willing to participate * Psychiatric illness situations that would limit compliance with study requirements * History of dementia * Incapacity for informed consent * Surgeon not willing to have patient complete study surveys * 19 patients already successfully recruited that month and the patient is non-Hispanic white. Primary Caregiver Exclusion Criteria: * Age \<18 * Non-English and non-Spanish speaking * Psychiatric illness situations that would limit compliance with study requirements Allied health professionals (Aim 4 at the end of the trial) Exclusion Criteria: * A trainee * Psychiatric illness situations that would limit compliance with study requirements
References
Publications (51)
- BACKGROUNDHolmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114. PMID 8717600
- BACKGROUNDMcNaughton CD, Cavanaugh KL, Kripalani S, Rothman RL, Wallston KA. Validation of a Short, 3-Item Version of the Subjective Numeracy Scale. Med Decis Making. 2015 Nov;35(8):932-6. doi: 10.1177/0272989X15581800. Epub 2015 Apr 15. PMID 25878195
- BACKGROUNDDegner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92. PMID 9145723
- BACKGROUNDBrehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. PMID 12926578
- BACKGROUNDGarvelink MM, Boland L, Klein K, Nguyen DV, Menear M, Bekker HL, Eden KB, LeBlanc A, O'Connor AM, Stacey D, Legare F. Decisional Conflict Scale Use over 20 Years: The Anniversary Review. Med Decis Making. 2019 May;39(4):301-314. doi: 10.1177/0272989X19851345. Epub 2019 May 29. PMID 31142194
- BACKGROUNDFowler FJ Jr, Sepucha KR, Stringfellow V, Valentine KD. Validation of the SDM Process Scale to Evaluate Shared Decision-Making at Clinical Sites. J Patient Exp. 2021 Nov 26;8:23743735211060811. doi: 10.1177/23743735211060811. eCollection 2021. PMID 34869847
- BACKGROUNDMcCreight MS, Rabin BA, Glasgow RE, Ayele RA, Leonard CA, Gilmartin HM, Frank JW, Hess PL, Burke RE, Battaglia CT. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs. Transl Behav Med. 2019 Nov 25;9(6):1002-1011. doi: 10.1093/tbm/ibz085.