Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
1 other identifier
interventional
26
1 country
1
Brief Summary
The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China. The main questions it aims to answer are:
- Is the intervention feasible and acceptable among participants?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention reduce participants' financial toxicity? Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness. Participants will receive comprehensive information support, including:
- Strategies on patient-physician costs discussion
- Skills for inquiring and tracking treatment-related costs
- Basic knowledge about health insurance
- Guidance on accessing and applying for financial assistance
- Suggestions for returning to normal life and work
- Strategies for holding a financial-related family meeting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
February 18, 2024
CompletedFirst Submitted
Initial submission to the registry
March 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2024
CompletedSeptember 25, 2024
June 1, 2024
1 month
March 28, 2024
September 23, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Eligibility rate
The eligibility rate will be calculated as the proportion of participants who meet the eligibility criteria among the total number of participants who will be assessed for eligibility. Reasons for participants' ineligibility will be recorded.
Approximately 1 month
Consent rate
The consent rate will be calculated as the proportion of eligible participants who consent to participate among those who will be approached and eligible for participation. Reasons for participants' refusal to participate will be recorded.
Approximately 1 month
Attrition rate
The attrition rate will be calculated as the percentage of participants who withdraw from or drop out of the study after enrolment. Reasons for participants' withdrawal or dropout will be recorded.
Through study completion, an average of 3 month
Adherence rate
The adherence rate will be calculated as the proportion of participants completing the entire program. Reasons for participants' nonadherence to the intervention will be recorded.
Through study completion, an average of 3 month
Patient-reported satisfaction
Participants' satisfaction will be measured with homemade 5 item questionnaire, with higher scores indicating higher satisfaction.
1 month after discharge in Financial Navigation Arm
Qualitative assessment of the intervention
Participants' experiences will be captured through one-on-one, semi-structured qualitative interviews.
1 month after discharge in Financial Navigation Arm
Secondary Outcomes (4)
Cost-related health literacy
Baseline, 1st month since baseline
Financial toxicity
Baseline, 1st month since baseline
Material domain of financial toxicity
1st month since baseline
Behavioral domain of financial toxicity
1st month since baseline
Study Arms (2)
Financial Navigation
EXPERIMENTALParticipants will receive financial navigation service. During their hospitalization, participants will receive face-to-face information support with material booklets. Following discharge, weekly financial navigation information will be sent via WeChat for 1 month. The financial navigation encompasses comprehensive information support: * Strategies on patient-physician costs discussion * Skills for inquiring and tracking treatment-related costs * Basic knowledge about health insurance * Guidance on accessing and applying for financial assistance * Suggestions for returning to normal life and work * Strategies for holding a financial-related family meeting
Usual Care
ACTIVE COMPARATORParticipants will receive usual care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support. When participants actively inquire about cancer treatment-related costs or financial planning strategies, financial navigators will answer their questions.
Interventions
One-on-one information support with material booklets during hospitalization. Weekly financial navigation information will be sent via WeChat after discharge for 1 month. The financial navigation encompasses comprehensive information support: * Strategies on patient-physician costs discussion * Skills for inquiring and tracking treatment-related costs * Basic knowledge about health insurance * Guidance on accessing and applying for financial assistance * Suggestions for returning to normal life and work * Strategies for holding a financial-related family meeting
Participants will receive usual oncology care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support.
Eligibility Criteria
You may qualify if:
- (1) Newly diagnosed with breast cancer and undergoing surgery during this admission;
- (2) Female, age 18 years or older;
- (3) Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- (4) Eastern Cooperative Oncology Group Performance Status 0-2;
- (5) Provided informed consent to participate in this study.
You may not qualify if:
- (1) Diagnosed with ductal carcinoma in situ (DCIS)
- (2) Presence of any serious psychiatric disorders;
- (3) Cognitive impairments;
- (4) Difficulty in reading, writing, or communicating in Chinese.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Yuan X, Chen L, Sun Y, Kuang Y, Ruan J, Tang L, Qiu J, Xing W. The development and preliminary evaluation of a financial navigation program among patients with breast cancer in China. Asia Pac J Oncol Nurs. 2025 Feb 17;12:100668. doi: 10.1016/j.apjon.2025.100668. eCollection 2025 Dec.
PMID: 40124659DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 9, 2024
Study Start
February 18, 2024
Primary Completion
March 28, 2024
Study Completion
May 7, 2024
Last Updated
September 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.