NCT07770243

Brief Summary

This pilot randomized controlled trial will test the feasibility and acceptability of an Artificial Intelligence-based Multidimensional Symptom Management (AIMS) intervention for post-treatment breast cancer survivors. Thirty-six participants will be randomly assigned (1:1) to receive either the AIMS intervention or usual care. Outcomes include feasibility (recruitment and retention), adherence, acceptability, symptom burden, psychological distress, quality of life, and safety of the AIMS intervention.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable breast-cancer

Status
not yet recruiting

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

Study Progress9%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

May 3, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

September 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

May 3, 2026

Last Update Submit

September 17, 2026

Conditions

Cancer SurvivorshipBreast Cancer

Keywords

artificial intelligencesymptom managementbreast cancer survivorsdigital health

Outcome Measures

Primary Outcomes (4)

  • Recruitment rate

    Number and percentage of eligible individuals who provide informed consent and are randomized. Recruitment rate will be calculated as: number randomized ÷ number eligible × 100.

    From recruitment commencement until completion of recruitment.

  • Participant retention at Week 12

    Number and percentage of randomized participants who complete the Week 12 assessment. Retention will be calculated as: number completing the Week 12 assessment ÷ number randomized × 100.

    Week 12

  • Adherence to the AIMS intervention

    Adherence will be assessed using system-generated usage data (e.g., frequency of logins) and supplemented by participant-reported usage logs.

    Weekly during Weeks 1-12, summarized at Weeks 4 and 12.

  • Acceptability and usability of the AIMS platform

    Among intervention-group participants, acceptability and usability will be assessed using the study-specific AIMS feedback questionnaire.

    Weeks 4 and 12.

Secondary Outcomes (6)

  • Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score

    Baseline, Week 4, and Week 12.

  • Kessler Psychological Distress Scale 10-Item Total Score

    Baseline, Week 4, and Week 12.

  • Hospital Anxiety and Depression Scale

    Baseline, Week 4, and Week 12.

  • Functional Assessment of Cancer Therapy-Breast

    Baseline, Week 4, and Week 12.

  • Health-services utilization

    Baseline, Week 4, and Week 12.

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will install and use the AIMS application.

Behavioral: AIMS platform

Control Group

NO INTERVENTION

Usual care

Interventions

AIMS platformBEHAVIORAL

The AIMS intervention is a digital self-management platform that provides personalized symptom monitoring, tailored self-management support, and interactive guidance.

Also known as: Artificial Intelligence-based Multidimensional Symptom Management (AIMS)
Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Female breast cancer survivors aged 18 years or older
  • Experiencing at least one symptom in the past month (e.g., fatigue, pain and insomnia, a score of ≥2 on the 0-10 Numeric Rating Scale (0 = "no fatigue", 10 = "worst fatigue")
  • Completed primary treatment (surgery, chemotherapy, or radiotherapy) within the last 24 months
  • Able to read Chinese and use a smartphone or tablet

You may not qualify if:

  • Unstable medical condition
  • Severe psychiatric disorders or cognitive impairment
  • Participation in another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Xianliang Liu, MD, PhD

CONTACT

(852) 3970 8790dxliu@hkmu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2026

First Posted

August 18, 2026

Study Start

September 16, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09