Health TrialsbyHealthPanel

Decision Aid for Women Newly Diagnosed With Breast Cancer

ConditionsBreast CancerDecision AidShared Decision MakingCost EffectivenessQuality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorXiamen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: BCT Aid Intervention GroupExperimental treatment 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Decision regret

Decision regret is measured using the Decision Regret Scale (DRS), a 5-item instrument that assesses distress or remorse associated with a healthcare decision. Higher scores indicate greater regret.

Time frame
At 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).
2

Shared Decision-Making

Shared decision-making is measured using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9), which assesses the patient's perceived involvement in the decision-making process. Higher scores indicate a higher level of shared decision-making.

Time frame
At post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).
3

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

Quality of life is measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 37-item instrument that assesses physical, social, emotional, and functional well-being, as well as breast cancer-specific concerns. Higher scores indicate better quality of life.

Time frame
At baseline (T0), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).
4

Health-related quality of life

Health-related quality of life is measured using the EQ-5D-5L, a standardized instrument that assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels. The EQ-5D-5L also includes a visual analog scale (EQ-VAS) for self-rated health. Scores are converted into utility values for cost-effectiveness analysis.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiamen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: