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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorOkayama University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathologically confirmed diagnosis of breast cancer

Aware of their diagnosis

Able to read and complete the questionnaire

Scheduled to undergo a standard chemotherapy regimen

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 1 trial group
Group A: Breast Cancer Survivors Undergoing Chemotherapy

Trial outcomes

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.

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

Secondary outcomes

1

Change in Financial Toxicity

Financial toxicity will be measured using the Comprehensive Score for Financial Toxicity (COST; version 1), an 11-item self-report instrument to quantify patients' perceptions of financial distress related to cancer treatment. The Chinese version of the COST was translated and validated among cancer survivors in mainland China, demonstrating good reliability and validity, with a Cronbach's alpha coefficient of 0.85. Items are rated on a 5-point Likert scale ranging from 0 to 4, with items 2, 3, 4, 5, 8, 9, and 10 reverse-scored, yielding total scores ranging from 0 to 44. Higher total scores indicate lower levels of financial toxicity. Based on established criteria, financial toxicity severity is categorized into four grades: no financial toxicity (COST ≥ 26), mild (14-25), moderate (1-13), and severe (0).

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

Change in Resilience

Resilience will be measured using the 14-item Resilience Scale (RS-14), a shortened version of the original 25-item RS, which is highly correlated with the original RS-25 (r = .97). The Chinese version of the RS-14 was validated among cancer survivors in mainland China, demonstrating excellent internal consistency (Cronbach's α = .93 for the total scale). Items are rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), yielding total scores from 14 to 98, with higher scores indicating greater resilience. A cut-off score of 64 has been proposed for distinguishing high versus low resilience among Chinese cancer survivors.

Time frame
Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)
3

Change in Posttraumatic Growth

Posttraumatic growth will be measured using the Posttraumatic Growth Inventory (PTGI), a 21-item self-report instrument. The Simplified Chinese version (PTGI-SC) was validated among breast cancer survivors in mainland China, demonstrating good internal consistency, with a Cronbach's alpha coefficient of 0.90 for the total score. Each item is rated on a 6-point Likert scale ranging from 0 ("I did not experience this change as a result of my crisis") to 5 ("I experienced this change to a very great degree as a result of my crisis"), yielding total scores ranging from 0 to 105, with higher scores indicating greater posttraumatic growth.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Okayama University

Lead sponsor

Henan Cancer Hospital

Collaborator

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