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

NCT03061175 | Completed Results DMC

• 5 other identifiers: Pro20150001914NCI-2017-00173131504P30CA072720R21CA187643
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stage 0 Breast Cancer; Stage I Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Self-Efficacy at 2-4 Week Follow up Survey

  2-4 week follow up

• Cancer Worry Assessed by 2-4 Week Follow-up Surveys

  2-4 week follow-up

• CPM Motivations Assessed by Surveys

  2-4 week follow up

• Perceived Risk of Recurrence Assessed by 2 Items on Surveys

  2-4 week follow-up

Other Outcomes (2)

• User Interface Satisfaction Survey

  2-4 week follow up

• B-Sure Use- Time

  2-4 week follow up

Study Arms (2)

Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)

EXPERIMENTAL

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: Internet-Based Intervention; Other: Survey Administration

Arm II (Usual Care)

EXPERIMENTAL

Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.

Other: Survey Administration

Interventions

Internet-Based Intervention OTHER

Receive web-based CPM-DA

Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)

Survey Administration OTHER

Ancillary studies

Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA); Arm II (Usual Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Future studies would benefit from a larger randomized trial including more minorities, lower education \& income, \& patients seen in community-based settings

Results Point of Contact

• Title: Dr. Sharon Manne, Associate Director, Population Science
• Organization: Rutgers Cancer Institute of New Jersey

mannesl@cinj.rutgers.edu

732-235-6759

Study Officials

• Sharon Manne

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: September 24, 2015
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: April 20, 2021
• Results First Posted: July 20, 2020

Record last verified: 2021-04

Locations

US (3)