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

NCT ID: NCT04190992

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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

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Decision Support Technique Breast Cancer

Keywords

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Decision aid Breast reconstruction E-based Technology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

E-based & personalized breast reconstruction surgery decision aid

Intervention Type 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.

Usual care

Intervention Type OTHER

A pamphlet introduce the introduction of types of surgery

Usual care group

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

Group Type OTHER

Usual care

Intervention Type OTHER

A pamphlet introduce the introduction of types of surgery

Interventions

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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.

Intervention Type OTHER

Usual care

A pamphlet introduce the introduction of types of surgery

Intervention Type OTHER

Other Intervention Names

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APP decision aid

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Su-Ying Fang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Su-Ying Fang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 34890354 (View on PubMed)

Other Identifiers

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B-ER-106-072

Identifier Type: -

Identifier Source: org_study_id