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| Name | Class |
|---|---|
| National Cheng Kung University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application (APP) group | Experimental | 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. |
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| Usual care group | Other | After completing the questionnaires at baseline, participants in the control group will only receive a pamphlet as usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-based & personalized breast reconstruction surgery decision aid | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Su-Ying Fang, PhD | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34890354 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Usual care | Other | A pamphlet introduce the introduction of types of surgery |
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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |