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

April 4, 2024 updated by: Xiaoyi Yuan, Fudan University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Financial Navigation

Participants 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
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
Active Comparator: Usual Care
Participants 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eligibility rate
Time Frame: Approximately 1 month
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
Time Frame: Approximately 1 month
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
Retention rate
Time Frame: Through study completion, an average of 3 month
The retention 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
Time Frame: Through study completion, an average of 3 month
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
Time Frame: 1 month after discharge in Financial Navigation Arm
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
Time Frame: 1 month after discharge in Financial Navigation Arm
Participants' experiences will be captured through one-on-one, semi-structured qualitative interviews.
1 month after discharge in Financial Navigation Arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-related health literacy
Time Frame: Baseline, 1 month after discharge
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
Financial toxicity
Time Frame: Baseline, 1 month after discharge
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
Material domain of financial toxicity
Time Frame: Baseline, 1 month after discharge
Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS).
Baseline, 1 month after discharge
Behavioral domain of financial toxicity
Time Frame: Baseline, 1 month after discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2312288-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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