Using AI to predict breast cancer recurrence and guide treatment decisions

Impact of an artificial intelligence-clinical decision support system on patient satisfaction and confidence in treatment decision-making for breast cancer recurrence prediction: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12901516

Enrollment

200

Registered

2025-02-07

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer

Interventions

This randomized controlled trial evaluates the impact of an artificial intelligence-clinical decision support system (AI-CDSS) on breast cancer treatment planning. Participants are randomly assigned u

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 years or older 2. Newly diagnosed with early-stage (Stage 0–II) breast cancer 3. Eligible for multiple treatment options (e.g., surgical and adjuvant therapies)

Exclusion criteria

Exclusion criteria: 1. Previous history of invasive cancer or breast cancer recurrence 2. Patients whose tumors are hormone receptor-negative or show HER2 overexpression on immunohistochemical staining 3. Cognitive or language barriers that preclude completing the surveys 4. Patients who are enrolled in other interventional trials that might interfere with the study outcomes

Design outcomes

Primary

Measure	Time frame
Patient satisfaction and confidence in treatment decision-making will be measured using the Satisfaction with Decision Scale (SWD) at baseline (pre-consultation) and 1, 3, and 6 months after the treatment consultation	—

Secondary

Measure	Time frame
The following secondary outcomes will be evaluated using validated questionnaires administered at baseline, 1, 3, and 6 months after the treatment consultation: 1. Patient understanding of recurrence risk measured using the Fear of Progression Questionnaire-12 (FoP-Q-12), to determine how well patients comprehend their individualized breast cancer recurrence risk 2. Decisional conflict measured using the Decisional Conflict Scale (DCS), which evaluates factors such as clarity of options and ease of decision-making 3. Quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	—

Measure

Time frame

The following secondary outcomes will be evaluated using validated questionnaires administered at baseline, 1, 3, and 6 months after the treatment consultation: 1. Patient understanding of recurrence risk measured using the Fear of Progression Questionnaire-12 (FoP-Q-12), to determine how well patients comprehend their individualized breast cancer recurrence risk 2. Decisional conflict measured using the Decisional Conflict Scale (DCS), which evaluates factors such as clarity of options and ease of decision-making 3. Quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

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Countries

Taiwan

Contacts

Public ContactHung-Sheng Shang

iamkeith@mail.ndmctsgh.edu.tw+886 920713130

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026