Skip to main content
OpenTrials
Completed

NCT Number: NCT06355440

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

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

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

  • (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.

Treatment and study plan

Financial navigation

Behavioral

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

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. 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.

  2. 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.

  3. Attrition rate

    Time frame: Through study completion, an average of 3 month

    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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Cost-related health literacy

    Time frame: Baseline, 1st 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. Financial toxicity

    Time frame: Baseline, 1st 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.

  3. Material domain of financial toxicity

    Time frame: 1st month since baseline

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

  4. Behavioral domain of financial toxicity

    Time frame: 1st 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Sep 25, 2024

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.