NCT03105076

Brief Summary

Both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar survival rates in breast cancer. These two treatment strategies have diverted cosmetic outcome and convenience. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. We have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on cancer patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and postsurgical depression. We expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after thier treatment sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

March 29, 2017

Last Update Submit

March 16, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Decisional conflict

    Total score of decisional conflict scale

    1 day before surgery

  • Knowledge

    Total score on knowledge scale

    1 day before surgery

Secondary Outcomes (2)

  • Decision regret

    4 weeks after surgery

  • Postsurgical depression

    4 weeks after surgery

Study Arms (2)

DAs group

EXPERIMENTAL

Shared decision making using decision aids

Other: Decision aids

Control group

NO INTERVENTION

Standard oral explanation guided with booklets

Interventions

Decision aidsOTHER

Shared decision making with decision aids

DAs group

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Taiwanese women newly diagnosed with stage 0 to 3 breast cancer (including patients with ductal carcinoma in situ), who were suitable for breast surgery
  • Patients who were able to give consent and complete the interview

You may not qualify if:

  • Patients were diagnosed with nonmalignant breast disease
  • Patients were offered neoadjuvant chemotherapy
  • Patients had cognitive impairment
  • Patients were physically unfit to be interviewed
  • Patients were non-Mandarin or -Taiwanese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, Taiwan

Location

Related Publications (1)

  • Lin SQ, Su CM, Wu HC, Chou YY, Yen YC, Tam KW. Effect of patient decision aids on decisional conflict and regret associated with breast cancer surgery: a randomized controlled trial. Breast Cancer. 2022 Sep;29(5):880-888. doi: 10.1007/s12282-022-01370-0. Epub 2022 May 19.

    PMID: 35589905DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Shared Decision Making Resource Center

    Shuang Ho Hospital, Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Shared Decision Making Resource Center

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 7, 2017

Study Start

April 1, 2017

Primary Completion

November 30, 2019

Study Completion

January 31, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)