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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-24

Study Completion Date

2018-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction

NCT03791138

Breast Cancer

COMPLETED NA

A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer

NCT06813053

Breast Cancer

RECRUITING NA

Patient-Specific Decision Aid System for Shared Decision Making About Breast Reconstruction

NCT05130580

Breast Carcinoma

ACTIVE_NOT_RECRUITING NA

Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

NCT03346161

Breast Cancer

COMPLETED PHASE1

Development of a Patient Decision Aid for Women Considering Breast Reconstruction

NCT04817709

Breast Carcinoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Receive web-based CPM-DA

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (Usual Care)

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

Group Type EXPERIMENTAL

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Internet-Based Intervention

Receive web-based CPM-DA

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No