Impact of Decision Aids on Breast Cancer Surgery Choice: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Decision aids

Detailed Description

Background:

For women with early-stage breast cancer, both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar survival rates, making psychological adjustment and quality-of-life issues pivotal in treatment choice. Using decision aids (DAs) is one way to provide information to patients and to involve them in making decisions about their treatment. We have developed a DAs to be administered after consultation for Taiwanese women deciding on breast surgery, and plan to conduct a randomized controlled trial (RCT) to evaluate the benefit of DAs on breast surgery decision making.

Patients and Methods:

Decision aids are interventions designed to help patients with early breast cancer to make deliberate choices among treatment options by providing information on those options and any potential outcome relevant to different breast cancer surgeries. Women considering breast cancer surgery are randomly assigned to receive a DAs or the standard oral conversation (control condition) after initial consultation, wherein surgeons disclosed the diagnosis and discussed treatment options with patients. Participants complete interview-based questionnaires 1 day before and 4 weeks after surgery. Primary outcome measures 1 day before surgery are decisional conflict and decision-making difficulties after consultation. Secondary outcomes are decision regret and postsurgical depression 1 month after surgery.

Hypothesis:

The DAs group are predicted to lower decisional conflict scores before surgery, and lower decision regret scores and depression scores 1 month after surgery compared with women in the control arm. Our study hopes to support the efficacy of DAs in helping breast cancer women to arrive at their breast surgery decision.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Shuang Ho Hospital, Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAs group; Shared decision making using decision aids	Other: Decision aids; Shared decision making with decision aids
No Intervention: Control group; Standard oral explanation guided with booklets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict	Total score of decisional conflict scale	1 day before surgery
Knowledge	Total score on knowledge scale	1 day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision regret	Total score of decision regret	4 weeks after surgery
Postsurgical depression	Total score of Hospital anxiety and depression scale (HADS)	4 weeks after surgery

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Shared Decision Making Resource Center, Shuang Ho Hospital, Taipei Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: W105HHC-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No