Living Well After Breast Surgery

The University of Texas System (UT)

Status: Completed

Conditions: Ductal Breast Carcinoma; Breast Cancer Female; Stage II Breast Cancer; Stage I Breast Cancer; Stage III Breast Cancer; Lobular Breast Carcinoma; Ductal Carcinoma in Situ

Treatments: Other: Educational website; Other: Breast reconstruction decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT03834532

2018-05-0009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Breast reconstruction decision aid

Control

Active Comparator group

Description:

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.

Treatment:

Other: Educational website