- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07651267
Financial Toxicity, Quality of Life, and Psychological Resources in Breast Cancer Survivors : A Longitudinal Study (FTQoL-BC)
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.
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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).
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: QIAN GUO, MSc
- Puhelinnumero: +8615093061919
- Sähköposti: pvky844k@s.okayama-u.ac.jp
Tutki yhteystietojen varmuuskopiointi
- Nimi: Takashi OHUE, PhD
- Sähköposti: t-ohue@okayama-u.ac.jp
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
-
Women were eligible if they:
- were aged 18 years or older;
- had a histopathologically confirmed diagnosis of breast cancer;
- were aware of their diagnosis;
- had the ability to read and complete the questionnaire;
- were scheduled to undergo a standard chemotherapy regimen.
Exclusion Criteria:
- (a) history of severe psychiatric disorders (e.g., schizophrenia or bipolar disorder); (b) another prior cancer diagnosis; (c) evidence of distant metastasis (stage IV disease); (d) severe comorbid conditions that could interfere with study participation or outcomes (e.g., severe cardiovascular disease or cognitive impairment).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Quality of life
Aikaikkuna: 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.
|
Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Financial Toxicity
Aikaikkuna: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
|
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).
|
Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
|
|
Change in Resilience
Aikaikkuna: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)
|
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.
|
Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and at 4 months (T3, completion of chemotherapy)
|
|
Change in Posttraumatic Growth
Aikaikkuna: Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
|
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.
|
Baseline (T1, prior to first chemotherapy cycle), 2 months (T2, mid-treatment), and 4 months (T3, completion of chemotherapy)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Takashi OHUE, PhD, Okayama University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Qian-Guo-BCs-2026-06
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Rintasyöpä
-
Shanghai Henlius BiotechEi vielä rekrytointiaRintasyöpä (TNBC (Triple Negative Breast Cancer))Kiina
-
Shenzhen Majory Biotechnology Co., Ltd.RekrytointiTriple-negative Breast Cancer (TNBC)Kiina
-
Universidad Europea de MadridEuropean University of Madrid; Hospital Universitario Infanta Leonor; Fundación... ja muut yhteistyökumppanitAktiivinen, ei rekrytointiTriple-negative Breast Cancer (TNBC)Espanja
-
Gangnam Severance HospitalRekrytointiHER2 Rikastettu alatyyppi Breast Cancer, Herzuma, PAM50 -tutkimusKorean tasavalta
-
Xijing HospitalAktiivinen, ei rekrytointiRintasyöpä | Rintasyöpä (TNBC (Triple Negative Breast Cancer))Kiina
-
Novartis PharmaceuticalsValmisMetastaattinen rintasyöpä (MBC) | Locally Advance Breast Cancer (LABC)Yhdistynyt kuningaskunta, Espanja
-
AkesoRekrytointiTriple-negative Breast Cancer (TNBC)Kiina
-
BioNTech SESeventh Framework ProgrammeValmisRintasyöpä (TNBC (Triple Negative Breast Cancer))Ruotsi, Saksa
-
Sun Yat-sen UniversityWest China Hospital; First Affiliated Hospital Xi'an Jiaotong UniversityRekrytointiTriple-negative Breast Cancer (TNBC)Kiina
-
Telomir Pharmaceuticals, Inc.Ei vielä rekrytointiaTriple-negative Breast Cancer (TNBC) | Metastaattinen kolminegatiivinen rintasyöpä | Edistynyt kolminkertaisesti negatiivinen rintasyöpä