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

Primary Purpose

Decision Support Technique, Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
E-based & personalized breast reconstruction surgery decision aid
Usual care
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Decision Support Technique focused on measuring Decision aid, Breast reconstruction, E-based Technology

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Application (APP) group

Usual care group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 4, 2019
Last Updated
December 5, 2019
Sponsor
National Cheng-Kung University Hospital
Collaborators
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT04190992
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decision Support Technique, Breast Cancer
Keywords
Decision aid, Breast reconstruction, E-based Technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Application (APP) group
Arm Type
Experimental
Arm 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.
Arm Title
Usual care group
Arm Type
Other
Arm Description
After completing the questionnaires at baseline, participants in the control group will only receive a pamphlet as usual care
Intervention Type
Other
Intervention Name(s)
E-based & personalized breast reconstruction surgery decision aid
Other Intervention Name(s)
APP decision aid
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
A pamphlet introduce the introduction of types of surgery
Primary Outcome Measure Information:
Title
Body image
Description
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.
Time Frame
Pre-surgery, 1 month, 8 month, 12 month post surgery
Title
Decision Regret
Description
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.
Time Frame
1 month, 8 month, 12 month post surgery
Title
Decision conflict
Description
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.
Time Frame
Pre-surgery, 1 week after intervention
Secondary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
Pre-surgery, 1 month, 8 month, 12 month post surgery
Title
Depression
Description
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.
Time Frame
Pre-surgery, 1 month, 8 month, 12 month post surgery
Title
Involvement in the Breast Reconstruction (BR) decision-making process scale
Description
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.
Time Frame
1 week after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Ying Fang, PhD
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34890354
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.
Results Reference
derived

Learn more about this trial

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

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