Breast CancerFTQoL-BCNCT07651267
Financial Toxicity, Quality of Life, and Psychological Resources in Breast Cancer Survivors : A Longitudinal Study
An observational study of Breast Cancer, run by Okayama University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female breast cancer patients receiving chemotherapy at Henan Cancer Hospital, China
Who may be able to join
- Histopathologically confirmed diagnosis of breast cancer
- Aware of their diagnosis
- Able to read and complete the questionnaire
- Scheduled to undergo a standard chemotherapy regimen
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Takashi OHUE, PhD contact
About this study
Official title: Psychological Resources Buffers of the Association Between Financial Toxicity and Quality of Life: A Longitudinal Study of Breast Cancer Survivors
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.
Read more
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.
Read the detailed description
Background:
Breast cancer is the most prevalent malignancy among women worldwide. In China, five-year survival rates have reached approximately 83%, making breast cancer survivors the largest cancer survivor group. Quality of life (QoL) has emerged as a key patient-centered outcome in oncology. Survivors undergoing chemotherapy commonly experience impaired physical function, psychosocial difficulties, and treatment-related symptoms that adversely affect QoL.
Financial toxicity encompasses both the objective financial burden and subjective financial distress arising from cancer-related costs. National survey data indicate that 82.6% of breast cancer survivors in China experience financial toxicity, with 40.9% reporting severe levels. Financial toxicity has been associated with treatment non-adherence, delayed care, and poorer QoL. A meta-analysis of 31 studies found a moderate negative association between financial toxicity and QoL. Survivors undergoing active treatment report higher financial toxicity than those who have completed therapy.
Psychological Resources:
Resilience is conceptualised as the capacity to adapt in the face of adversity, trauma, or significant stressors, which is linked to better QoL in cancer populations. A meta-analysis of 66 studies found that higher resilience was significantly associated with better QoL. Emerging cross-sectional evidence suggests that resilience partially mediates the association between financial toxicity and QoL; however, its longitudinal buffering role remains unclear.
Posttraumatic growth (PTG) refers to positive psychological change that emerges through the process of struggling with highly challenging life circumstances. A systematic review of 37 studies found a positive association between PTG and QoL. Higher financial distress has been associated with greater PTG. Although PTG appears to moderate the relationship between cancer-related stressors and health outcomes, its longitudinal role in buffering financial toxicity on QoL has not been established.
Theoretical Framework:
This study is guided by Conservation of Resources (COR) theory, which conceptualizes financial toxicity as a resource-loss stressor. Within this framework, resilience and PTG are positioned as psychological resources that offset resource loss and may buffer the adverse impact of financial toxicity on QoL.
Study Design:
This is a non-intervention longitudinal observational cohort study. Data will be collected at three time points corresponding to key chemotherapy phases: prior to the first chemotherapy cycle (baseline, T1), at mid-treatment (2 months, T2), and at the completion of chemotherapy (4 months, T3). The study is conducted at Henan Cancer Hospital, China.
Participants:
Sample size: G*Power calculation assuming medium effect size (f² = 0.10), α = 0.05, power = 0.95, and 3 predictors yielded a minimum of 132 participants. Adjusting for 20% attrition, the target sample size is at least 160 participants.
Measures:
Financial toxicity: Comprehensive Score for Financial Toxicity (COST); Quality of life: Functional Assessment of Cancer Therapy - General (FACT-G); Resilience: Resilience-14; Posttraumatic growth: Posttraumatic Growth Inventory (PTGI) Sociodemographic and clinical characteristics collected at baseline (age, menopausal status, histological grade, occupational status, medical insurance type, monthly household income, treatment type.
Statistical Analysis:
Primary analysis: Linear mixed-effects models (LMM) will examine longitudinal changes in QoL and the moderating effects of resilience and PTG on the financial toxicity-QoL relationship. Interaction terms (financial toxicity × resilience, financial toxicity × PTG, and time interactions) will be included to evaluate whether buffering effects vary across treatment phases.
Supplementary analysis: Cross-lagged panel models within a structural equation modeling (SEM) framework will examine temporal and directional relationships among financial toxicity, psychological resources, and QoL (e.g., financial toxicity at T1 predicting resilience or PTG at T2, and subsequently QoL at T3).
- Conditions
- Breast Cancer
- Keywords
- Breast cancer survivors, Quality of life, Financial toxicity, Resilience, Posttraumatic growth, Longitudinal study, Women
- Medical subject headings
- Breast Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
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.
Measured: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)
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.
Measured: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start10 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Cancer Hospital
- Responsible party
- Principal investigator, Qian Guo, Okayama University
- Investigators
- Takashi OHUE, PhD, Study chair, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651267
- Sponsor's protocol ID
- Qian-Guo-BCs-2026-06
- Acronym
- FTQoL-BC
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Resources Buffers of the Association Between Financial Toxicity and Quality of Life: A Longitudinal Study of Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07651267
- Acronym / sponsor ID
- FTQoL-BC / Qian-Guo-BCs-2026-06
- Conditions
- Breast Cancer
- Keywords
- Breast cancer survivors, Quality of life, Financial toxicity, Resilience, Posttraumatic growth, Longitudinal study, Women
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Collaborators
- Henan Cancer Hospital
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Breast cancer is the most prevalent malignancy among women worldwide. In China, five-year survival rates have reached approximately 83%, making breast cancer survivors the largest cancer survivor group. Quality of life (QoL) has emerged as a key patient-centered outcome in oncology. Survivors undergoing chemotherapy commonly experience impaired physical function, psychosocial difficulties, and treatment-related symptoms that adversely affect QoL.
Financial toxicity encompasses both the objective financial burden and subjective financial distress arising from cancer-related costs. National survey data indicate that 82.6% of breast cancer survivors in China experience financial toxicity, with 40.9% reporting severe levels. Financial toxicity has been associated with treatment non-adherence, delayed care, and poorer QoL. A meta-analysis of 31 studies found a moderate negative association between financial toxicity and QoL. Survivors undergoing active treatment report higher financial toxicity than those who have completed therapy.
Psychological Resources:
Resilience is conceptualised as the capacity to adapt in the face of adversity, trauma, or significant stressors, which is linked to better QoL in cancer populations. A meta-analysis of 66 studies found that higher resilience was significantly associated with better QoL. Emerging cross-sectional evidence suggests that resilience partially mediates the association between financial toxicity and QoL; however, its longitudinal buffering role remains unclear.
Posttraumatic growth (PTG) refers to positive psychological change that emerges through the process of struggling with highly challenging life circumstances. A systematic review of 37 studies found a positive association between PTG and QoL. Higher financial distress has been associated with greater PTG. Although PTG appears to moderate the relationship between cancer-related stressors and health outcomes, its longitudinal role in buffering financial toxicity on QoL has not been established.
Theoretical Framework:
This study is guided by Conservation of Resources (COR) theory, which conceptualizes financial toxicity as a resource-loss stressor. Within this framework, resilience and PTG are positioned as psychological resources that offset resource loss and may buffer the adverse impact of financial toxicity on QoL.
Study Design:
This is a non-intervention longitudinal observational cohort study. Data will be collected at three time points corresponding to key chemotherapy phases: prior to the first chemotherapy cycle (baseline, T1), at mid-treatment (2 months, T2), and at the completion of chemotherapy (4 months, T3). The study is conducted at Henan Cancer Hospital, China.
Participants:
Sample size: G*Power calculation assuming medium effect size (f² = 0.10), α = 0.05, power = 0.95, and 3 predictors yielded a minimum of 132 participants. Adjusting for 20% attrition, the target sample size is at least 160 participants.
Measures:
Financial toxicity: Comprehensive Score for Financial Toxicity (COST); Quality of life: Functional Assessment of Cancer Therapy - General (FACT-G); Resilience: Resilience-14; Posttraumatic growth: Posttraumatic Growth Inventory (PTGI) Sociodemographic and clinical characteristics collected at baseline (age, menopausal status, histological grade, occupational status, medical insurance type, monthly household income, treatment type.
Statistical Analysis:
Primary analysis: Linear mixed-effects models (LMM) will examine longitudinal changes in QoL and the moderating effects of resilience and PTG on the financial toxicity-QoL relationship. Interaction terms (financial toxicity × resilience, financial toxicity × PTG, and time interactions) will be included to evaluate whether buffering effects vary across treatment phases.
Supplementary analysis: Cross-lagged panel models within a structural equation modeling (SEM) framework will examine temporal and directional relationships among financial toxicity, psychological resources, and QoL (e.g., financial toxicity at T1 predicting resilience or PTG at T2, and subsequently QoL at T3).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female breast cancer patients receiving chemotherapy at Henan Cancer Hospital, China
Key inclusion criteria (4 listed)
- Histopathologically confirmed diagnosis of breast cancer
- Aware of their diagnosis
- Able to read and complete the questionnaire
- Scheduled to undergo a standard chemotherapy regimen
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in 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)
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.
3 secondary outcomes
Change in Financial Toxicity
Time frame: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
Change in Resilience
Time frame: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)
Change in Posttraumatic Growth
Time frame: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Takashi OHUE, PhD contact
Takashi OHUE, PhD study chair
Okayama University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Okayama University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QIAN GUO, MSc (+8615093061919, pvky844k@s.okayama-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.