NCT03834532

Brief Summary

Decision making about whether to have breast reconstruction after mastectomy can be difficult, and previous studies have found that many women are not well informed about their options. Patient decision aids can improve decision quality for a variety of health conditions. This pilot randomized study seeks to determine how a patient decision aid about breast reconstruction affects the quality of decisions about reconstruction including patient knowledge, concordance between preferences and treatment, and decisional regret.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2021

Completed
Last Updated

November 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

January 28, 2019

Last Update Submit

November 1, 2021

Conditions

Breast Cancer FemaleStage I Breast CancerStage II Breast CancerStage III Breast CancerDuctal Carcinoma in SituDuctal Breast CarcinomaLobular Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Number of patients enrolled per month

    To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the number of patients enrolled per month.

    12 months

  • Proportion of patients retained at 6 months

    To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the proportion of patients retained through the 6 month outcome assessment.

    6 months

Secondary Outcomes (7)

  • How a patient decision aid about breast reconstruction affects knowledge about reconstruction.

    6 months

  • How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.

    6 months

  • How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.

    6 months

  • How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.

    6 months

  • How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomized to the intervention group will receive a breast reconstruction decision aid. Participants will be provided instructions on how to access and navigate the decision aid. Participants will access the decision aid through a website link that is emailed to them or on a tablet at the study site.

Other: Breast reconstruction decision aid

Control

ACTIVE COMPARATOR

Participants randomized to the control group will receive two website pages on healthy living with breast cancer from an educational website. Participants will be provided instructions on how to access and navigate the website pages. Participants will access the website pages through a link that is emailed to them or on a tablet at the study site.

Other: Educational website

Interventions

Breast reconstruction decision aidOTHER

The breast reconstruction decision aid is a web-based, interactive tool that participants will use after the first breast surgery visit and before a plastic surgery visit or surgery. The decision aid provides information about post-mastectomy breast reconstruction and helps the participant clarify their preferences related to the procedure.

Also known as: Web-based tool
Intervention
Educational websiteOTHER

The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.

Also known as: Website
Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Adult (18 years or older)
  • New diagnosis of incident or recurrent Stage I-III ductal or lobular carcinoma, or Ductal Carcinoma in Situ (DCIS)
  • Not yet had mastectomy
  • Considering or planning to have mastectomy
  • Able to read and speak English
  • Competent to make health care decisions

You may not qualify if:

  • Male
  • Age less than 18 years
  • Diagnosis of stage IV breast cancer, inflammatory breast cancer, phyllodes, or sarcoma
  • Already had mastectomy for this diagnosis
  • Planning to have breast conservation therapy
  • Not being treated by a Texas Oncology surgeon or oncologist
  • Not able to read and speak English
  • Not competent to make health care decisions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Oncology

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCarcinoma, Ductal, BreastCarcinoma, Lobular

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, Ductal

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 8, 2019

Study Start

February 18, 2019

Primary Completion

June 11, 2021

Study Completion

June 11, 2021

Last Updated

November 2, 2021

Record last verified: 2021-11

Locations

US(1)