Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy

Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy

This pilot randomized clinical trial studies how well a web-based decision aid works in improving informed decisions in patients with stage 0-IIIA breast cancer considering contralateral prophylactic mastectomy (CPM). A web-based decision aid (DA) may help doctors determine how patients make decisions about whether or not to have contralateral prophylactic mastectomy.

Study Overview

• Status: Completed
• Conditions: Stage 0 Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer
• Intervention / Treatment: Other: Survey Administration; Other: Internet-Based Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. To develop a feasible web-based decision aid (DA).

SECONDARY OBJECTIVES:

I. To provide preliminary data on the impact of the contralateral prophylactic mastectomy (CPM)-DA on preparedness to make the CPM decision, decisional conflict, CPM knowledge, psychosocial factors, perceived risk for cancer in the healthy/breast/metastatic disease, cancer recurrence/metastasis worry, cancer distress and intention to have CPM.

OUTLINE:

PHASE I (PROTOTYPE DEVELOPMENT AND TESTING): Patients attend an interview and are asked questions about experiences with CPM, reasons they chose and did not choose CPM, and CPM satisfaction for 60 minutes. Patients then receive access to web-based CPM-DA and attend an interview over 90 minutes to provide feedback on module and to complete a prototype evaluation.

PHASE II (CPM-DA FEASIBILITY TRIAL): Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo usual care (UC) available to patients considering CPM and receive information from a medical oncologist about CPM.

ARM II: Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.

After completion of study treatment, patients are followed up at 2-4 weeks and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)
• PHASE I: Speaks and reads English
• PHASE I: Women with sporadic cancers (WSC) (does not have hereditary breast/ovarian cancer syndrome [BReast CAncer gene (BRCA) carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; the Tyrer-Cuzick model calculates a personal lifetime risk of breast cancer based on multiple factors; it has become the standard model because it incorporates not only factors such as estrogen exposure and first degree relatives, but also second degree relatives and paternal lineage; a lifetime risk of 20% or greater is considered high risk and would necessitate increased screening methods to the traditional annual mammogram; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation
• PHASE I: Able to provide meaningful informed consent
• PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy)
• PHASE II: Has home internet access
• PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer
• PHASE II: Speaks and reads English
• PHASE II: WSC (does not have hereditary breast/ovarian cancer syndrome [BRCA carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation
• PHASE II: Able to provide meaningful informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA); Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)- Decision Aid (DA).	Other: Survey Administration; Ancillary studies; Other: Internet-Based Intervention; Receive web-based CPM-DA
Experimental: Arm II (Usual Care); Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.	Other: Survey Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants	CPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.	2-4 week follow up
Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys	Preparedness for the CPM decision was assessed using a 16-item scale adapted from the Ottawa Preparation for Decision Making scale modified to address the CPM decision. Items evaluated the amount of and satisfaction with information about CPM. Scores were reported as a mean across the items and ranged from 1-4 with 1 = Strongly Disagree; 2= Moderately Disagree; 3 = Moderately Agree; 4= Strongly Agree Higher scores = more prepared. Outcomes reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions.	2-4 week follow up
Decisional Conflict Assessed by the Decisional Conflict Scale	The Ottawa Decisional Conflict scale has 16 items and five subscales: support for the decision, uncertainty about the decision, level of relevant information, clarity of relevant values, and effective decision. Items are rated on a 5-point Likert scale (0= Strongly Disagree to 4 = Strongly Agree). Scores for the five subscales were calculated by an average that was multiplied by 25, which is recommended by the scale's developers. Thus, scores can range from 0 (no decision conflict) to 100 (high decision conflict). Higher scores indicate more decisional conflict.	2-4 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy at 2-4 Week Follow up Survey	Self-efficacy was a 3-item measure of confidence in the ability to manage worries and uncertainty about a possible recurrence of breast cancer, concerns about future surveillance, and worries about undergoing future surveillance. Results reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions. Scores were reported as the mean across the 3 items and ranged from 1 = Not at all confident; 2 = Somewhat confident; 3 = Moderately confident; 4 = Very confident; 5 = Extremely confident. Higher scores indicate more self-efficacy.	2-4 week follow up
Cancer Worry Assessed by 2-4 Week Follow-up Surveys	Worry is measured by a single item that asks how worried the participant is about having another form of breast cancer on a four-point Likert scale 1= not at all worried and 4 = very worried. Higher scores indicate more worry. Results reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions	2-4 week follow-up
CPM Motivations Assessed by Surveys	Reasons for CPM were measured by an 11-item scale developed after a review of the qualitative and quantitative literature on motivations for CPM and interviews with women who chose or did not choose CPM. Scored were reported as a mean score across the 11 items. The scale was scored on a 1-4 scale from not at all important to Yes, extremely important and Higher score = more reasons/motivations. Outcomes reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions	2-4 week follow up
Perceived Risk of Recurrence Assessed by 2 Items on Surveys	Perceived risk was measured by two items. One item assessed contralateral breast cancer risk risk after unilateral mastectomy and radiation. The second item assessed perceived risk for chest wall recurrence after CPM. The first item asked "Out of 100 women with early breast cancer are treated with a single mastectomy or lumpectomy and radiation, about how many will develop breast cancer in the "other breast" in the 5 years after treatment? ___ women out of 100". The second item assessed risk for chest wall recurrence after bilateral mastectomy using the same scale 2. "If 100 women with early breast cancer have both breasts removed, how many will have breast cancer come back in the chest wall area of the "other breast" in the five years after treatment?". Outcomes reported as Estimated marginal means and standard errors for usual care and B-Sure decision aid conditions of the # out of 100 that women reported.	2-4 week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Interface Satisfaction Survey	The scale has 27 items and four subscales: usefulness, ease of use, ease of learning, and satisfaction. Scales ranged from 1-7 with 1 being not at all or strongly disagree up to 7 being definitely or strongly agree.	2-4 week follow up
B-Sure Use- Time	Basic descriptive information will be gathered regarding the length of time modules are viewed. B-Sure use will be assessed by average time spent in B-Sure	2-4 week follow up

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2015
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma In Situ
• Other Study ID Numbers: Pro20150001914; P30CA072720 (U.S. NIH Grant/Contract); NCI-2017-00173 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 131504 (Other Identifier: Rutgers Cancer Institute of New Jersey); R21CA187643 (U.S. NIH Grant/Contract)