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Trial Title:
Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
NCT ID:
NCT06484140
Condition:
Breast Neoplasm Female
Financial Toxicity
Financial Navigation
Conditions: Official terms:
Breast Neoplasms
Financial Stress
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Financial Navigation
Description:
During hospitalization, participants will receive needs assessment, and one-on-one
cost-related health education with a material booklet. Resource and service referral will
be delivered face-to-face or by phone when the navigator identifies unaddressed problems.
Within three months after discharge, participants will receive monthly follow-up phone
calls and personalized counseling via WeChat.
Arm group label:
Financial Navigation
Intervention type:
Other
Intervention name:
Usual Care
Description:
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.
Arm group label:
Usual Care
Summary:
The goal of this study is to access the 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:
- Does the intervention alleviate participants' financial toxicity?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention improve participants' shared decision-making?
- Does the intervention reduce participants' perceived stress?
Researchers will compare the financial navigation program with usual oncology care to
evaluate its effectiveness.
Participants will receive the comprehensive financial navigation, including:
- Needs assessment;
- Cost-related health education, mainly including topics regarding communication of
cost, treatment-related cost, health insurance policies, and family support;
- Resource and service referral;
- Personalized counseling.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Newly diagnosed with breast cancer and undergoing surgery during this admission;
- Female, age 18 years or older;
- Receiving or expected to receive one or more of the following therapies:
chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- Eastern Cooperative Oncology Group Performance Status 0-2;
- Provided informed consent to participate in this study.
Exclusion Criteria:
- Diagnosed with ductal carcinoma in situ (DCIS)
- Presence of any serious psychiatric disorders;
- Cognitive impairments;
- Difficulty in reading, writing, or communicating in Chinese.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
June 17, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06484140
