Financial Toxicity, Quality of Life, and Psychological Resources in Breast Cancer Survivors : A Longitudinal Study

NCT07651267 | Not Yet Recruiting

• 1 other identifier: Qian-Guo-BCs-2026-06
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Breast cancer survivors face significant financial stress (also called financial toxicity) due to the high costs of cancer treatment. This financial stress can worsen quality of life. Previous studies have demonstrated that breast cancer survivors may draw on inner psychological strengths to cope effectively. This study aims to examine whether psychological resources, specifically resilience and posttraumatic growth (PTG), buffer the longitudinal association between financial toxicity and quality of life (QoL) among breast cancer survivors. Hypotheses: H1: Financial toxicity is negatively associated with QoL over time. H2: Resilience moderates the association between financial toxicity and QoL, such that higher resilience attenuates the negative impact of financial toxicity. H3: Posttraumatic growth (PTG) moderates the association between financial toxicity and QoL, such that moderate to high levels of PTG attenuate the negative impact of financial toxicity. Participants will complete questionnaires at three time points: before their first chemotherapy cycle, at two months (mid-treatment), and at four months (end of chemotherapy). The questionnaires measure financial stress, quality of life, resilience, and posttraumatic growth. The study plans to enroll at least 160 participants. Data will be analyzed using statistical methods that track changes across time and test whether resilience and posttraumatic growth buffer the impact of financial stress on quality of life. All data will be de-identified and stored securely.

Conditions

Breast Cancer

Keywords

Breast cancer survivors; Quality of life; Financial toxicity; Resilience; Posttraumatic growth; Longitudinal study; Women

Outcome Measures

Primary Outcomes (1)

• Change in Quality of life

  The Chinese version of the Functional Assessment of Cancer Therapy-General (FACT-G) is a validated 27-item instrument used to assess health-related quality of life. It comprises four domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The instrument has demonstrated good reliability, with Cronbach's α coefficients exceeding 0.80 for all domains. Total scores range from 0 to 108, with higher scores indicating better quality of life.

  Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)

Secondary Outcomes (3)

• Change in Financial Toxicity

  Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)

• Change in Resilience

  Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)

• Change in Posttraumatic Growth

  Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)

Study Arms (1)

Breast Cancer Survivors Undergoing Chemotherapy

Breast cancer survivors receiving chemotherapy at Henan Cancer Hospital are assessed by questionnaire at three time points during chemotherapy to examine the relationships among financial toxicity, psychological resources (resilience and posttraumatic growth), and quality of life.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female breast cancer patients receiving chemotherapy at Henan Cancer Hospital, China

You may qualify if:

• Histopathologically confirmed diagnosis of breast cancer
• Aware of their diagnosis
• Able to read and complete the questionnaire
• Scheduled to undergo a standard chemotherapy regimen

You may not qualify if:

• History of severe psychiatric disorders (e.g., schizophrenia or bipolar disorder)
• Another prior cancer diagnosis
• Evidence of distant metastasis (stage IV disease)
• Severe comorbid conditions that could interfere with study participation or outcomes (e.g., severe cardiovascular disease or cognitive impairment)

Sponsors & Collaborators

• Okayama University: lead
• Henan Cancer Hospital: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Takashi OHUE, PhD

  Okayama University

  STUDY CHAIR

Central Study Contacts

QIAN GUO, MSc

CONTACT

+8615093061919; pvky844k@s.okayama-u.ac.jp

Takashi OHUE, PhD

CONTACT

t-ohue@okayama-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06