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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04190992
• Other study ID #: B-ER-106-072
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: December 31, 2020
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Decision Support Technique

Intervention

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.
• Usual care
A pamphlet introduce the introduction of types of surgery

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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