E-Based Technology to Provide Decision Aid on Breast Reconstruction for Women With Breast Cance

National Cheng-Kung University

Status: Unknown

Conditions: Decision Support Technique; Breast Cancer

Treatments: Other: E-based & personalized breast reconstruction surgery decision aid; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04190992

B-ER-106-072

Details and patient eligibility

About

Using decision aids has been demonstrated to support women to make treatment decision effectively. However, these studies focused on the decision of receiving breast conservative surgery or mastectomy, had short term follow-ups on decision satisfaction.The aims of this study were: Evaluate the effect of E-based & personalized breast reconstruction surgery decision aid on women's decision satisfaction and mental health.

Full description

Randomized controlled trial will be used to examine the effect of E-based & personalized breast reconstruction surgery decision aid on decision satisfaction, body image, anxiety and depression. Participants will be randomly assigned into either experimental or control groups with 88 women in each group. After completing the questionnaires at baseline, participants in the experimental group will be asked to receive a E-based & personalized breast reconstruction surgery decision aid at clinic. Control group will only receive pamphlet and usual care. All participants will be followed up 1 week after consultation, and 1 month, 8 month and 12 month after surgery.

Enrollment: 176 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age of at least 20 years or under 20 years but married
• females newly diagnosed with breast cancer who are candidates for mastectomy
• ability to read and speak Taiwanese or Mandarin

Exclusion criteria

• Women with cancer recurrence
• poor cognitive function
• diagnosed with psychiatric disease

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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176 participants in 2 patient groups

Application (APP) group

Experimental group

Description:

After completing the questionnaires at baseline, participants in the experimental group will be asked to receive a pamphlet and an E-based \& personalized breast reconstruction surgery decision aid at clinic.

Treatment:

Other: Usual care

Other: E-based & personalized breast reconstruction surgery decision aid

Usual care group

Other group

Description:

After completing the questionnaires at baseline, participants in the control group will only receive a pamphlet as usual care

Treatment:

Other: Usual care