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
Conditions
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.
Interventions
OTHERBreast reconstruction decision aid
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.
OTHEREducational website
The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.
Sponsors
Ohio State University
Washington University School of Medicine
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients enrolled per month | 12 months | 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. |
| Proportion of patients retained at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| How a patient decision aid about breast reconstruction affects knowledge about reconstruction. | 6 months | Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module. |
| How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. | 6 months | Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Rating Scale. |
| How a patient decision aid about breast reconstruction affects decision making outcomes. | 6 months | Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale. |
Countries
United States
Outcome results
None listed