Skip to main content
OpenTrials
Completed

NCT Number: NCT06484140

Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasm Female Behavior Behavioral Symptoms Financial Navigation Financial Stress Financial Toxicity Stress, Psychological

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Financial navigation

Behavioral

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.

Usual Care

Other

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.

Primary outcomes

  1. Financial toxicity

    Time frame: Baseline, 1st month and 3rd month since baseline

    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.

  2. Material domain of financial toxicity

    Time frame: 1st month and 3rd month since baseline

    Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS).

  3. Behavioral domain of financial toxicity

    Time frame: 1st month and 3rd month since baseline

    Behavioral domain of financial toxicity will be measured by employment changes and cost-related nonadherence with 6 items adapted from MEPS and previous literature.

Secondary outcomes

  1. Cost-related health literacy

    Time frame: Baseline, 1st month and 3rd month since baseline

    The cost-related health literacy will be measured with homemade 10-item questionnaire, with higher scores indicating higher cost-related health literacy.

  2. Shared decision-making

    Time frame: Baseline, 1st month and 3rd month since baseline

    The shared decision-making ability will be measured with 9-item shared decision-making questionnaire (SDM-Q-9); higher scores (range, 0-45) indicating a greater degree of participants' involvement in shared decision-making.

  3. Perceived stress

    Time frame: Baseline, 1st month and 3rd month since baseline

    The perceived stress will be measured with Perceived Stress Scale (PSS); higher scores (range, 0-56) indicating greater perceived stress.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Evaluation of the Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.