Clinical trial NCT03834532: Living Well After Breast Surgery
Official title: Living Well After Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Ductal Carcinoma in Situ
Ductal Breast Carcinoma
Lobular Breast Carcinoma
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Washington University School of Medicine
First posted: 2019-02-08
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer.

Participants will complete up to three surveys; a baseline survey before viewing the decision aid or website, a second survey immediately after viewing the decision aid or website, and a third survey six months after surgery. Tablets will be made available to participants at the study site through which they can complete the surveys and view the decision aid or website. Participants will have the options of viewing the decision aid or website outside of the study site, and completing the three surveys electronically or on paper.

The baseline survey and second survey will each take approximately 45 minutes for participants to complete. The third survey will take approximately 30 minutes for participants to complete.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients enrolled per month
timeFrame: 12 months
measure: Proportion of patients retained at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: How a patient decision aid about breast reconstruction affects knowledge about reconstruction.
timeFrame: 6 months
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
timeFrame: 6 months
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
timeFrame: 6 months
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
timeFrame: 6 months
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
timeFrame: 6 months
measure: How a patient decision aid about breast reconstruction affects decision making outcomes.
timeFrame: 6 months
measure: How a patient decision aid about breast reconstruction affects decision making outcomes.
timeFrame: 6 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Oncology
state: Texas
Study officials:
References: