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The Breast Reconstruction Decision Aid (RECONJOINT) to Improve Shared Decision-Making in Breast Cancer Patients or those at High Risk who are Considering Breast Reconstruction Surgery after a Mastectomy
Trial Status: active
This clinical trial studies whether the Breast Reconstruction Decision Aid (RECONJOINT) can be used to improve shared decision-making in breast cancer patients, or those who are at high risk of developing breast cancer and are considering breast reconstruction surgery after surgical removal of the breast (mastectomy). Patients who have breast reconstruction surgery often experience dissatisfaction when the outcomes of that surgery do not reflect their individual preferences or desired outcomes. Before-surgery consultations (or “pre-operative consultations”) with a surgeon often center around the reconstructive surgery itself rather than the outcomes of the surgery. There are many things to consider related to the outcomes of different surgical approaches such as surgical complications, recovery time, and scarring that results from the surgery. Patients will have varying opinions on what matters most to them. When making decisions about breast reconstruction surgery, it is important for both the patient and the surgeon to understand the patient’s preferences and desired outcomes. The RECONJOINT decision tool provides information about breast reconstruction treatment options and helps patients decide which breast reconstruction outcomes they feel are most important. By helping the patient and surgeon understand the patient’s individual preferences and desired outcomes, the tool may lead to improved overall satisfaction with the breast reconstruction surgery. This may be an effective way to improve shared decision-making between the patient and the surgeon before breast reconstruction surgery after a mastectomy.
Inclusion Criteria
FOCUS GROUP PARTICIPANTS: A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record
FOCUS GROUP PARTICIPANTS: ≥ 18 years old
FOCUS GROUP PARTICIPANTS: Considering post-mastectomy breast reconstruction
RCT PARTICIPANTS (PATIENTS): A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record
RCT PARTICIPANTS (PATIENTS): ≥ 18 years old
RCT PARTICIPANTS (PATIENTS): Considering post-mastectomy breast reconstruction
RCT PARTICIPANTS (PATIENTS): Have an appointment scheduled for consultation with a plastic surgery provider
RCT PARTICIPANTS (PHYSICIANS): Provides breast reconstruction care ≥ 50% of the time. This is defined as over half of the surgeon’s cases in the preceding calendar year being related to breast reconstruction surgery
Exclusion Criteria
FOCUS GROUP PARTICIPANTS: Not considering post-mastectomy breast reconstruction
FOCUS GROUP PARTICIPANTS: Non-English proficiency
RCT PARTICIPANTS (PATIENTS): Not considering postmastectomy breast reconstruction
RCT PARTICIPANTS (PATIENTS): Recurrent or metastatic breast cancer
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07335354.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Evan Matros
Phone: 646-608-8044
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Evan Matros
Phone: 646-608-8044
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Evan Matros
Phone: 646-608-8044
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Evan Matros
Phone: 646-608-8044
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Evan Matros
Phone: 646-608-8044
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Evan Matros
Phone: 646-608-8044
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Evan Matros
Phone: 646-608-8044
PRIMARY OBJECTIVE:
I. Determine the feasibility of a hybrid effectiveness-implementation study that investigates the effectiveness and implementation potential of a decision aid to improve shared decision-making in breast reconstruction.
SECONDARY OBJECTIVES:
I. Determine the intervention usability.
II. Determine the feasibility of intervention using the Feasibility of Intervention Measure (FIM) scores.
III. Determine the acceptability of the intervention.
IV. Evaluate preliminary efficacy by estimating and comparing measures of shared decision-making, decisional conflict, and knowledge, and decision satisfaction between groups.
V. Examine the potential for implementing the RECONJOINT decision tool into clinical care by the use of semi-structured interviews with patients and surgeons who participate in the intervention arm.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I (FOCUS GROUPS): Patients complete a focus group to inform the finalization of the interview guides needed for the second qualitative component of the study (interviews) on study.
GROUP II (RANDOMIZED CONTROLLED TRIAL [RCT]): Reconstructive surgeons are randomized to 1 of 2 arms and patients are assigned to the arm to which their reconstructive surgeon was randomized.
ARM I: Patients complete the RECONJOINT decision tool over 25 minutes within 60 days of consent and before initial reconstructive surgery consult visit. Patients then receive an electronic (e)-mail with the results of their preferences from completing the tool as well as an explanation of their results and more information pertaining to breast reconstruction. Reconstructive surgeons also receive a copy of the patient's treatment preferences. The reconstructive surgeon and patient then review results, discuss the importance of treatment attributes, and make a joint treatment decision with active consideration of the patient's preferences for reconstruction during reconstructive surgery consult visit. Patients also receive an American Society of Plastic Surgeons Brochure about breast reconstruction, access to institutional websites about breast reconstruction, and routine preoperative counseling on study.
ARM II: Patients receive an American Society of Plastic Surgeons Brochure about breast reconstruction, access to institutional websites about breast reconstruction, and routine preoperative counseling within 60 days of consent and before initial reconstructive surgery consult visit.
After completion of study intervention, RCT patients are followed for up to 60 days after initial reconstructive surgery consult.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
