Clinical trial NCT04190992: E-Based Technology to Provide Decision Aid on Breast Reconstruction for Women With Breast Cance
Official title: The Effect of E-Based Technology to Provide Personalized Decision Aid on Breast Reconstruction for Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decision Support Technique
Breast Cancer
Keywords: Decision aid
Breast reconstruction
E-based Technology
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: National Cheng Kung University
First posted: 2019-12-09
Enrollment: 176
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body image
timeFrame: Pre-surgery, 1 month, 8 month, 12 month post surgery
measure: Decision Regret
timeFrame: 1 month, 8 month, 12 month post surgery
measure: Decision conflict
timeFrame: Pre-surgery, 1 week after intervention
Secondary outcomes:
measure: Anxiety
timeFrame: Pre-surgery, 1 month, 8 month, 12 month post surgery
measure: Depression
timeFrame: Pre-surgery, 1 month, 8 month, 12 month post surgery
measure: Involvement in the Breast Reconstruction (BR) decision-making process scale
timeFrame: 1 week after intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Su-Ying Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fang SY, Lin PJ, Kuo YL. Long-Term Effectiveness of a Decision Support App (Pink Journey) for Women Considering Breast Reconstruction Surgery: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 10;9(12):e31092. doi: 10.2196/31092.