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

The Effect of E-Based Technology to Provide Personalized Decision Aid on Breast Reconstruction for Women With Breast Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Decision Support Technique
• Intervention / Treatment: Other: E-based & personalized breast reconstruction surgery decision aid; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application (APP) group; 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.	Other: E-based & personalized breast reconstruction surgery decision aid; This decision aid contains information regarding surgical options, including breast reconstruction and mastectomy, such as the advantages and disadvantages, the complication probabilities of each option, a value clarification exercise for the patient's self-evaluation, and a summary of the participant's decision-making process.; Other Names: APP decision aid; Other: Usual care; A pamphlet introduce the introduction of types of surgery
Other: Usual care group; After completing the questionnaires at baseline, participants in the control group will only receive a pamphlet as usual care	Other: Usual care; A pamphlet introduce the introduction of types of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body image	The Body Image Scale (BIS) has ten items rated on a four-point Likert scale (0 [not at all] to 3 [very much]), with total scores ranging from 0 to 30. Higher scores indicate greater BI distress.	Pre-surgery, 1 month, 8 month, 12 month post surgery
Decision Regret	Decision Regret Scale (DRS) accesses "distress or remorse after a surgery decision". This instrument contains 5 items. The items were summed, divided by 5, and multiplied by 25. Higher scores indicate greater decision regret.	1 month, 8 month, 12 month post surgery
Decision conflict	Decision Conflict Scale (DCS) accesses the perception of uncertainty in information, values or support for surgery options. This instrument contains 16 items and was developed by O'Connor. The items were summed, divided by 16, and multiplied by 25. Higher scores indicate greater decision conflict.	Pre-surgery, 1 week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	The Hospital Anxiety and Depression Scale (HADS) assesses symptoms of anxiety and depression. The HADS includes 14 items, of which 7 measure anxiety, and 7 measure depression. All items are scored using a 0-3 point scale, with higher scores indicating more depressive symptoms. Cut-off scores are used to categorize anxiety and depressive symptoms, with values of over 8 indicating possible anxiety and depression, and 11 or above indicating probable anxiety.	Pre-surgery, 1 month, 8 month, 12 month post surgery
Depression	The Hospital Anxiety and Depression Scale (HADS) assesses symptoms of anxiety and depression. The HADS includes 14 items, of which 7 measure anxiety, and 7 measure depression. All items are scored using a 0-3 point scale, with higher scores indicating more depressive symptoms. Cut-off scores are used to categorize anxiety and depressive symptoms, with values of over 8 indicating possible anxiety and depression, and 11 or above indicating probable depression.	Pre-surgery, 1 month, 8 month, 12 month post surgery
Involvement in the Breast Reconstruction (BR) decision-making process scale	Involvement in the BR decision-making process was divided into two subscales, one accesses the perception of medical information about surgery obtained with 6 items and the other assesses the perception of partners' involvement in the BR decision-making process with 7 items. The scale used a five-point Likert scale (1 [strongly disagree] to 5 [strongly agree]); the higher the score, the greater the amount of information the participants believed they had obtained and the greater the participants perceived their partner's involvement in the BR decision-making process.	1 week after intervention

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: National Cheng Kung University
• Investigators: Principal Investigator: Su-Ying Fang, PhD, National Cheng Kung University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): July 25, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Breast reconstruction; Decision aid; E-based Technology
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: B-ER-106-072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No