Clinical trial NCT06355440: Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
Official title: Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Financial Toxicity
Financial Navigation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Eligibility rate
timeFrame: Approximately 1 month
measure: Consent rate
timeFrame: Approximately 1 month
measure: Attrition rate
timeFrame: Through study completion, an average of 3 month
measure: Adherence rate
timeFrame: Through study completion, an average of 3 month
measure: Patient-reported satisfaction
timeFrame: 1 month after discharge in Financial Navigation Arm
measure: Qualitative assessment of the intervention
timeFrame: 1 month after discharge in Financial Navigation Arm
Secondary outcomes:
measure: Cost-related health literacy
timeFrame: Baseline, 1st month since baseline
measure: Financial toxicity
timeFrame: Baseline, 1st month since baseline
measure: Material domain of financial toxicity
timeFrame: 1st month since baseline
measure: Behavioral domain of financial toxicity
timeFrame: 1st month since baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: