Effects of a Large Language Model-Driven Chatbot on Reproductive Concerns After Cancer

NCT07741266 | Not Yet Recruiting

• 1 other identifier: HSEARS20260512015
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

Reproductive health has emerged as a critical yet overlooked concern among Adolescent and Young Adult (AYA) cancer survivors, given their compromised potential for biological parenthood in prime childbearing years. Large language models (LLMs) offer a promising solution to bridge onco-fertility service gaps by integrating evidence-based knowledge and therapeutic frameworks. This pilot randomized controlled trial aims to assess the feasibility and preliminary effectiveness of an LLM-driven chatbot versus electronic brochure in addressing reproductive concerns among AYA cancer survivors.

Conditions

Chatbot; Adolescent and Young Adult Cancer Survivors; Large Language Model; Reproductive Health

Outcome Measures

Primary Outcomes (3)

• Total interaction time

  The cumulative time spent interacting with the chatbot or reading the electronic brochure during the study period.

  At 4 weeks, 8 weeks

• Number of active days

  The total number of distinct days on which a participant actively engaged with the chatbot or accessed the electronic brochure.

  At 4 weeks, 8 weeks

• Dropout rate

  The proportion of randomized participants who do not complete the intervention or outcome measures.

  At 4 weeks, 8 weeks

Secondary Outcomes (5)

• Reproductive concerns

  At baseline, 4 weeks, 8 weeks

• Psychological flexibility

  At baseline, 4 weeks, 8 weeks

• Depression

  At baseline, 4 weeks, 8 weeks

• Life quality

  At baseline, 4 weeks, 8 weeks

• Decisional conflict

  At baseline, 4 weeks, 8 weeks

Study Arms (2)

Chatbot

EXPERIMENTAL

Other: Chatbot

Electronic brochure

ACTIVE COMPARATOR

Other: Electronic brochure

Interventions

Chatbot OTHER

A large language model-driven chatbot that incorporates acceptance and commitment therapy, a verified onco-fertility knowledge base, and relevant policy information.

Also known as: FLORA

Chatbot

Electronic brochure OTHER

An electronic brochure that contains psychoeducational materials, verified onco-fertility knowledge, and relevant policy information.

Electronic brochure

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (1) 15-39-year-old females; (2) cancer diagnosis between ages 15-39; (3) current or prior concerns regarding fertility; (4) proficiency in Mandarin Chinese; and (5) access to a mobile device for intervention delivery.

You may not qualify if:

• (1) Involvement in the chatbot co-design phases; (2) inability to provide informed consent; (3) significant sensory, cognitive, or psychological impairments precluding meaningful participation; and (4) acute illness at the time of recruitment.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Science and Technology of China: collaborator

Study Sites (2)

The University of Science and Technology of China

Hefei, Anhui, 230026, China

Location

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Central Study Contacts

Xinyu Feng

CONTACT

852 56144565; xinyu211.feng@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)