Trials / Unknown
UnknownNCT04190992
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- Sponsor
- National Cheng-Kung University Hospital · Academic / Other
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Usual care | A pamphlet introduce the introduction of types of surgery |
Timeline
- Start date
- 2017-05-05
- Primary completion
- 2019-07-25
- Completion
- 2020-12-31
- First posted
- 2019-12-09
- Last updated
- 2019-12-09
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04190992. Inclusion in this directory is not an endorsement.