Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

Breast Neoplasm Female Clinical Trial

Official title:

Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355440
• Other study ID #: 2312288-16
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Fudan University
• Contact: Xiaoyi Yuan, Master
• Phone: (+86) 18918305439
• Email: 22211170009[@]m.fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Financial Stress
• Financial Toxicity

Intervention

Behavioral:
• Financial Navigation
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

Other:
• Usual Care
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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Cost-related health literacy	The cost-related health literacy will be measured with homemade 10-item questionnaire, with higher scores indicating higher cost-related health literacy.	Baseline, 1 month after discharge
Secondary	Financial toxicity	Financial toxicity will be measured with the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2); lower scores (range, 0-44) indicating greater financial toxicity.	Baseline, 1 month after discharge
Secondary	Material domain of financial toxicity	Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS).	Baseline, 1 month after discharge
Secondary	Behavioral domain of financial toxicity	Behavioral domain of financial toxicity will be measured by employment changes and cost-related nonadherence with 6 items adapted from MEPS and previous literature.	Baseline, 1 month after discharge