NCT04190992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

December 4, 2019

Last Update Submit

December 5, 2019

Conditions

Decision Support TechniqueBreast Cancer

Keywords

Decision aidBreast reconstructionE-based Technology

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • Anxiety

    Pre-surgery, 1 month, 8 month, 12 month post surgery

  • Depression

    Pre-surgery, 1 month, 8 month, 12 month post surgery

  • Involvement in the Breast Reconstruction (BR) decision-making process scale

    1 week after intervention

Study Arms (2)

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.

Other: E-based & personalized breast reconstruction surgery decision aidOther: Usual care

Usual care group

OTHER

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

Other: Usual care

Interventions

E-based & personalized breast reconstruction surgery decision aidOTHER

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.

Also known as: APP decision aid
Application (APP) group
Usual careOTHER

A pamphlet introduce the introduction of types of surgery

Application (APP) groupUsual care group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women with cancer recurrence
  • poor cognitive function
  • diagnosed with psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 34890354DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Su-Ying Fang, PhD

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 9, 2019

Study Start

May 5, 2017

Primary Completion

July 25, 2019

Study Completion

December 31, 2020

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

TW(1)