Decision Aid for Women Newly Diagnosed With Breast Cancer

NCT07497256 | Not Yet Recruiting

• 2 other identifiers: KY-2024-049-H017231101009
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this multi-center randomized controlled trial is to determine if the clinical decision aid (BCT Aid) works to help breast cancer patients participate in decision-making and make high-quality decisions, thereby improving the rate of breast-conserving surgery and quality of life. The main questions it aims to answer are: Does the BCT Aid significantly increase the rate of breast-conserving surgery compared to usual care? Does the BCT Aid reduce decision conflict and decision regret, while improving shared decision-making and quality of life? Does the BCT Aid demonstrate better cost-effectiveness in terms of health resource utilization? Researchers will compare the BCT Aid to usual care (standard clinical consultation) to evaluate the effectiveness and cost-effectiveness of BCT Aid. Participants will: Be randomly assigned to either the intervention group (receiving the BCT Aid intervention for 6 months) or the control group (usual care). Complete assessments including decision conflict and shared decision-making at baseline (T0), post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention), decision regret at T2 and T3, and quality of life at T0, T2, and T3, with additional EQ-5D-5L measurements at baseline, 3, 6, 9, and 12 months for cost-effectiveness analysis. Have clinical outcomes (breast-conserving surgery rate) and health resource utilization data collected from medical records.

Conditions

Breast Cancer; Decision Aid; Shared Decision Making; Cost Effectiveness; Quality of Life

Keywords

breast cancer; decision aid; decision conflict; shared decision making; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• Decision conflict

  Decision conflict is measured using the Decisional Conflict Scale (DCS), a 16-item instrument that assesses uncertainty in decision-making, factors contributing to uncertainty, and perceived effectiveness of decision-making. Higher scores indicate greater decisional conflict.

  At baseline (T0), post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).

Secondary Outcomes (5)

• Decision regret

  At 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).

• Shared Decision-Making

  At post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).

• Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)

  At baseline (T0), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).

• Health-related quality of life

  At baseline (T0), 3 months, 6 months (T2, post-intervention), 9 months, and 12 months (T3, 6 months post-intervention).

• Breast-conserving surgery rate

  At 6 months (post-intervention)

Study Arms (2)

BCT Aid Intervention Group

EXPERIMENTAL

Participants in this arm will receive a multimodal shared decision-making decision aid (BCT Aid) for 6 months. The BCT Aid includes three module: value model, personalized survival prediction module, and information module.

Behavioral: BCT Aid

Usual Care Group

ACTIVE COMPARATOR

Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice.

Behavioral: Usual Care

Interventions

BCT Aid BEHAVIORAL

The BCT Aid is a multimodal shared decision-making decision aid for newly diagnosed breast cancer patients, designed to support patient participation in clinical decision-making and to improve the quality of decisions regarding surgical treatment. It consists of three core components: (1) a values module to elicit patient preferences for surgical options; (2) a personalized survival prediction module to provide individualized prognostic information; and (3) an information module offering evidence-based knowledge on breast cancer treatment, recovery, and rehabilitation. The intervention will be delivered to the BCT Aid intervention group for 6 months, with breast cancer patients receiving the tool at diagnosis and having access to it throughout the decision-making process.

Also known as: decision aid

BCT Aid Intervention Group

Usual Care BEHAVIORAL

Usual care consists of standard clinical consultation and routine information provision as per hospital practice. Patients receive standard care from their healthcare providers, including routine discussions regarding diagnosis, treatment options, and follow-up plans. No additional decision aid or structured shared decision-making intervention will be provided.

Also known as: Standard Care

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Newly diagnosed with breast cancer, with clinical stage 0-II, or stage III eligible for breast-conserving surgery after neoadjuvant chemotherapy.
• Clinically eligible for breast-conserving surgery and considering one of the following surgical options: breast-conserving surgery, mastectomy, or mastectomy with reconstruction.
• Clinically eligible for adjuvant therapy after surgery.
• Able to access the internet via smartphone.
• Able to read, speak, and understand Mandarin.

You may not qualify if:

• Male breast cancer patients.
• Clinically eligible for only one surgical option or not candidates for surgery.
• Have a history of other malignancies, except adequately treated cervical carcinoma in situ and basal cell carcinoma of the skin.
• Presence of psychiatric disorders, visual or hearing impairments, or cognitive impairment.

Sponsors & Collaborators

• Xiamen University: lead

Study Sites (3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Women and Children's Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361003, China

Location

Xiang'an Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361102, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jiemin Zhu

CONTACT

+86 15960212649; jieminzhu@xmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)