Abstract
Background
Increasing research has linked mental health to reduced adherence in chronic diseases, yet this interplay remains insufficiently explored in chronic myeloid leukemia (CML).
Methods
We conducted a cross-sectional online survey to analyze the critical role of non-treatment factors among Chinese CML patients receiving tyrosine kinase inhibitor (TKI) therapy. Anxiety and depression were assessed with the GAD-7/PHQ-9, quality of life (QoL) with the SF-12. Medication adherence was assessed using the Medication Possession Ratio (MPR), calculated as the percentage of actual medication possession days relative to the theoretical medication possession days. Binary logistic regression was used to identify factors associated with psychological burden and adherence.
Results
Of 486 patients included, 52.5% reported anxiety (mild: 45.3%; moderate-severe: 7.2%) and 40.5% reported depression (mild: 29.8%; moderate-severe: 10.7%). QoL was impaired in both physical and mental domains (mean SF-12 PCS 46.22; MCS 45.62). Employment status and higher SF-12 PCS scores were significantly associated with lower psychological burden. Compared with patients reporting medium or high adherence, those with low adherence had higher rates of anxiety (20.2% vs 3.5% and 3.3%, P < 0.001) and depression (17.4% vs 8.8% and 8.7%, P=0.007) and lower MCS scores (43.72 vs 46.45 and 45.75, P=0.021). Binary logistic regression analysis showed that therapy duration, line of treatment, and psychological burden were significantly associated with adherence, patients with elevated psychological burden had 76.0% lower adherence odds (OR=0.24; 95% CI: 0.13–0.44; P<0.001), the strongest influencing factor.
Conclusion
Psychological burden is the strongest determinant of impaired medication adherence in Chinese patients with CML on TKI therapy. Interventions that reduce psychological burden, particularly by promoting social-role participation and improving perceptions of physical health, may offer a new dimension for optimizing long-term outcomes in CML.
Keywords: chronic myeloid leukemia, psychological issues, quality of life, medication adherence, tyrosine kinase inhibitors, anxiety, depression
Introduction
Tyrosine kinase inhibitors (TKI) have fundamentally transformed the trajectory of chronic myeloid leukemia (CML), turning it from a rapidly fatal disease into a chronic condition with a near-normal life expectancy.1,2 With a 10-year survival rate exceeding 90%, the clinical focus has shifted significantly toward optimizing patients’ quality of life (QoL) as a primary objective.3,4 However, drug-related adverse events (AEs) and psychological stress caused by prolonged treatment often result in self-discontinuation, negatively impacting clinical efficacy.5 Traditional treatment approaches have typically emphasized physiological metrics while neglecting critical issues such as emotional distress, cognitive biases, and strained family relationships, all of which can influence treatment adherence and diminish therapeutic outcomes. Research suggests that integrated psychological interventions can enhance treatment confidence, alleviate psychosomatic symptoms, and prolong survival in similar cancers, such as breast cancer6,7 and other solid tumors,8–10 whether such benefits extend to CML, where the pathway from psychological burden to outcomes may be mediated by adherence remains unknown.
Emerging evidence reveals a concerning paradox: while TKI can sustain physical survival, they may inadvertently compromise mental health. Up to 60% of patients with CML experience clinically significant anxiety or depression during long-term treatment,11 a proportion that surpasses that observed in many patients with solid tumors. This mental health burden is not merely secondary, it directly threatens treatment sustainability and functional recovery. Increasing research has linked mental health to reduced adherence in chronic diseases,12,13 yet the interplay of these factors remains insufficiently explored within the context of CML.
Several mechanisms may explain how psychological distress undermines adherence in CML. Depression and anxiety can erode motivation for preventive therapy, particularly in asymptomatic disease, where the perceived benefit of daily medication remains abstract.14 Anxiety regarding TKI AEs—gastrointestinal toxicity, hematologic abnormalities, or long-term sequelae—may drive intentional dose reduction or medication avoidance as a coping strategy.15 In addition, cognitive symptoms of depression, such as impaired memory and reduced executive function, together with social withdrawal associated with anxiety, can disrupt the behavioral routines necessary for consistent dosing.16 These psychological barriers may be particularly pronounced in CML, where asymptomatic remission is frequently achievable: patients may rationalize discontinuation based on perceived wellness, with psychological burden amplifying this risk. Whether psychological burden serves as a primary driver of non-adherence or as a marker of broader treatment disengagement remains unclear, yet this distinction is essential for designing targeted interventions to sustain long-term TKI therapy and prevent treatment failure.
China carries one of the largest CML burdens worldwide, and Chinese patients are diagnosed at a substantially younger median age (approximately 45–50 years) than their Western counterparts,17 implying longer lifetime exposure to TKI therapy and a longer window during which psychological burden may erode adherence. Furthermore, the financial and healthcare context in China is distinctive: the transition from originator imatinib to domestic generic TKIs, tiered reimbursement under the national medical insurance schemes, and the national centralized drug-procurement policy have produced marked regional and socioeconomic disparities in out-of-pocket treatment costs,18,19 which are closely intertwined with both mental well-being and treatment persistence. Psychological distress among Chinese patients is frequently under-recognized and under-treated, owing to the stigma attached to mental illness and the limited integration of psychological screening into hematology care pathways. Existing evidence on psychological burden and medication adherence in CML derives predominantly from Western populations, large-scale data from China remain scarce.
Therefore, this study developed a structured questionnaire to collect comprehensive baseline data (including medication adherence, psychological status, and QoL)—from CML patients nationwide, coupled with data obtained from clinical records. We hypothesized that psychological burden, manifested as anxiety and depression, is independently and inversely associated with medication adherence and QoL among Chinese patients with CML receiving TKI therapy, after adjustment for demographic and clinical characteristics. This research aims to analyze the critical role of non-treatment factors in CML management, providing evidence-based support for incorporating psychological screening into CML care pathways, with the ultimate goal of enhancing patients’ QoL. This research aims to analyze the critical role of non-treatment factors in the management of CML among the Chinese population, providing evidence-based support for incorporating psychological screening into the diagnostic and treatment pathways for CML, with the ultimate goal of enhancing patients’ QoL.
Methods
Patients
This was a single-center, cross-sectional study conducted at a leading regional CML treatment center in China. The cross-sectional online survey was administered via Wenjuanxing, a widely used online survey platform in China, between m February 10, 2025, to March 10, 2025. Physicians introduced the study during scheduled visits, and research coordinators provided electronic consent forms and the electronic questionnaire via WeChat. Each IP address was allowed to complete the questionnaire only once. Inclusion criteria for analysis: ① diagnosed as CML-CP; ② ≥1 year of ongoing TKI therapy; ③ age ≥18 years; and ④ regular follow-up and complete diagnosis and treatment data. The study received approval from the Institutional Ethics Committee and was conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent prior to completing the questionnaire.
Survey Design
We developed a cross-sectional survey to assess the mental health, QoL, and medication adherence of CML patients using an electronic questionnaire. The questionnaire consists of five sections: (1) patient informed consent, (2) demographic and treatment characteristics, (3) medication status, (4) self-reported outcomes, including QoL, mental health, and medication adherence, and (5) psychological assessment. The second section gathers fundamental patient information, including name, age, gender, comorbidities, and date of diagnosis. The third section addresses medication status, detailing first-line therapies, current medication regimens, and adherence (medication adherence was comprehensively assessed using a dual-method approach: ① a structured self-report questionnaire, completed by patients at follow-up visit, to capture subjective information including dosing frequency, missed doses, and deviations from scheduled administration times; and ② Medication adherence was assessed using the Medication Possession Ratio (MPR), calculated as the percentage of actual medication possession days relative to the theoretical medication possession days. Adherence classification was based primarily on MPR. Self-reported dosing information was used complementarily. In addition, therapeutic drug monitoring (TDM) results, where available from routine clinical care, were cross-referenced with self-reports and MPR as a verification tool to identify discrepancies, patients with significant inconsistencies underwent further evaluation to verify actual dosing practices. Adherence was stratified into three categories: high adherence (≥90%), moderate adherence (80–89%), and low adherence (<80%). The fourth section evaluates patient QoL using the SF-12 scale,20 which comprises eight dimensions: overall health, physical functioning, role-physical, bodily pain, vitality, social functioning, role-emotional, and mental health. Each item has an associated score, with reverse scoring applied to items 1, 8, 9, and 10. The first four dimensions constitute the physical component summary (PCS), while the latter four create the mental component summary (MCS). Scores are first converted to percentages, then subjected to Z transformation to generate standardized scores. These scores are multiplied by factor score coefficients to compute initial PCS and MCS scores, subsequently transformed into T-scores with a mean of 50 and a standard deviation of 10, where higher values indicate better QoL. The fifth section assesses psychological conditions using the GAD-721 and the PHQ-9.22 The GAD-7 scale includes seven self-reported questions on anxiety, with a maximum score of 21, higher scores reflect greater anxiety severity. Anxiety levels based on the total GAD-7 score are categorized into four groups: normal (0–4), mild (5–9), and moderate to severe (≥10). The PHQ-9 consists of nine self-reported questions on depression, with a maximum score of 27, higher scores indicate greater depression severity. Depression symptoms are classified into four levels based on the total PHQ-9 score: normal (0–4), mild (5–9), and moderate to severe (≥10). It should be pointed out that reference values for GAD-7, and PHQ-9 specific to Chinese CML patients are currently unavailable, thus, cutoffs were based on international validation studies.
Statistical Analyses
The sample size was determined by the number of eligible patients under follow-up during the study period (convenience sampling), no a priori power calculation was performed. Post-hoc assessment indicated that outcome events per candidate predictor exceeded the conventional threshold of 10 supporting model stability. All variables used in the analyses were complete for the 486 participants, no imputation or case deletion was required. Categorical variables were expressed as frequency and percentage. For normally distributed continuous data, means and standard deviations (SD) were reported; otherwise, medians and interquartile ranges (IQR) were presented. Comparisons of categorical variables employed Pearson chi-squared or Fisher’s exact test, while continuous variables were evaluated using the Kruskal–Wallis test. In analyzing the factors influencing psychological burden, patients were divided into two groups: those well-adjusted psychologically (with anxiety and depression scores <10) and those with elevated clinical psychological burden (with anxiety or depression scores≥10). Participants were categorized as non-adherent (<80%) or adherent (≥80%) to enable analysis of adherence-related determinants. Variables demonstrating a P. value <0.2 in univariate analyses were incorporated into binary logistic regression analysis. Statistical analyses were conducted using IBM SPSS Statistics version 26.0 (IBM Corp., Armonk, NY, USA), with statistical significance defined as P.value < 0.05.
Results
Baseline Co-Variates
During the study period, approximately 700 CML patients were under routine follow-up at our center. 520 completed the survey (response rate: 74.3%), and 486 were included in the final analysis (excluding 12 invalid responses,10 less than 18 years and 12 questionnaires from patients who had been on medication for less than one year, Figure 1). Baseline co-variates are presented in Table 1. Among the participants, 276 (56.8%) were male. The median age of respondents was 45 years (IQR 34–55 years), and the median duration of TKI therapy was 5.94 years (IQR 3.60–9.79 years). A total of 95 participants (19.5%) reported having at least one comorbidity, with hypertension (9.9%) and diabetes (4.9%) being the most common. Imatinib was the most common initial TKI (328, 67.5%), and 309 (63.6%) patients remained on first-line therapy at the time of survey. Specifically, 178 (36.6%) are taking imatinib, 116 (23.9%) are on dasatinib, 73 (15.0%) are using nilotinib, 110 (22.6%) are prescribed flumatinib, and 9 (1.9%) are receiving olverembatinib. Notably, 396 (81.5%) patients reported having a job prior to diagnosis, but only 321 (66.0%) were employed after diagnosis, representing a net decline of 75 patients (15.4%) in employment after diagnosis.
Figure 1.
Flow diagram of participant recruitment and adherence classification. Adherence was assessed by MPR and categorized as low (<80%), medium (80–89%), or high (≥90%).
Table 1.
Demographic and Clinical Characteristics of Patients with Chronic Myeloid Leukemia
| Variables | Number of Patients (N=486) |
|---|---|
| Sex (male), n (%) | 276 (56.8) |
| Age (years), median (IQR) | 45 (34–55) |
| TKI therapy duration (years), median (IQR) | 5.94 (3.60–9.79) |
| Comorbiditya, n (%) | 95 (19.5) |
| Hypertension | 48 (9.9) |
| Diabetes | 24 (4.9) |
| Coronary heart disease | 8 (1.6) |
| Hepatitis B | 11 (2.3) |
| Others | 24 (4.9) |
| Initial TKI therapy, n (%) | |
| Imatinib | 328 (67.5) |
| Dasatinib | 36 (7.4) |
| Nilotinib | 42 (8.6) |
| Flumatinib | 80 (16.5) |
| Current treatment lines, n (%) | |
| 1st line | 309 (63.6) |
| 2nd line | 103 (21.2) |
| 3rd line or above | 74 (15.2) |
| Current TKI treatment, n (%) | |
| Imatinib | 178 (36.6) |
| Dasatinib | 116 (23.9) |
| Nilotinib | 73 (15.0) |
| Flumatinib | 110 (22.6) |
| Olverembatinib | 9 (1.9) |
| Working status, n (%) | |
| Working before diagnosis | 396 (81.5) |
| Working after diagnosis | 321 (66.0) |
Notes: aComorbidity categories were not mutually exclusive, 115 comorbidity events were recorded among 95 patients.
Abbreviations: TKI, tyrosine kinase inhibitor; IQR, interquartile range.
Psychological Burden and QoL
Among the 486 patients diagnosed with CML, 52.5% reported experiencing anxiety (mild: 45.3%, moderate-severe: 7.2%), while 40.5% exhibited signs of depression (mild: 29.8%, moderate-severe: 10.7%). Concurrently, patients demonstrated a dual decline in QoL across both physical and mental health domains, as evidenced by the SF-12 scores: the PCS score was 46.22±6.55 and the MCS score was 45.62±9.18. Both scores were lower than the normative reference value of 50 points, indicating a synchronous impairment in psychosomatic functioning (Table 2).
Table 2.
Psychological Burden and Quality of Life of Patients with Chronic Myeloid Leukemia
| Variables | Number of Patients (N=486) |
|---|---|
| Anxiety (GAD-7) | |
| Score, mean±SD | 4.43±3.46 |
| None, n (%) | 231 (47.5) |
| Mild, n (%) | 220 (45.3) |
| Moderate to severe, n (%) | 35 (7.2) |
| Depressive (PHQ-9) | |
| Score, mean±SD | 4.23±4.34 |
| None, n (%) | 289 (59.5) |
| Mild, n (%) | 145 (29.8) |
| Moderate to severe, n (%) | 52 (10.7) |
| Quality of life (SF-12) | |
| PCS score, mean±SD | 46.22±6.55 |
| MCS score, mean±SD | 45.62±9.18 |
Abbreviations: SD, standard deviation; GAD-7, 7-item Generalized Anxiety Disorder scale; PHQ-9, 9-item Patient Health Questionnaire; SF-12, 12-item Short Form Health Survey; PCS, physical component summary; MCS, mental component summary.
Association Between Psychological Burden and Medication Adherence
As shown in Table 3, significant associations were observed between psychological burden and medication adherence. Patients with low adherence exhibited markedly higher rates of moderate-to-severe anxiety (20.2% compared to 3.3–3.5% in the medium/high adherence groups, P < 0.001) and depression (17.4% vs 8.7–8.8%, P = 0.007). Additionally, the score for the SF-12 MCS was substantially lower in the low-adherence cohort (mean=43.72) compared to the medium/high adherence groups (mean= 46.45 and 45.75, P=0.021), while no significant intergroup differences were noted in the PCS scores (P=0.156). These findings suggest that psychological distress, particularly impaired mental health, is a critical predictor of suboptimal medication adherence among CML patients.
Table 3.
Association Between Psychological Burden, Quality of Life and Medication Adherence
| Variables | Lowa (n=109) | Medium (n=227) | High (n=150) | P valueb |
|---|---|---|---|---|
| Anxiety (GAD-7) | <0.001 | |||
| None, n (%) | 36 (33.0) | 120 (52.9) | 75 (50.0) | |
| Mild, n (%) | 51 (46.8) | 99 (43.6) | 70 (46.7) | |
| Moderate to severe, n (%) | 22 (20.2) | 8 (3.5) | 5 (3.3) | |
| Depression (PHQ-9) | 0.007 | |||
| None, n (%) | 49 (45.0) | 147 (64.8) | 93 (62.0) | |
| Mild, n (%) | 41 (37.6) | 60 (26.4) | 44 (29.3) | |
| Moderate to severe, n (%) | 19 (17.4) | 20 (8.8) | 13 (8.7) | |
| Quality of life (SF-12) | ||||
| PCS score, mean±SD | 45.43±6.34 | 46.87±6.87 | 45.81±6.11 | 0.156c |
| MCS score, mean±SD | 43.72±8.09 | 46.45±9.72 | 45.75±8.93 | 0.021c |
Notes: aAdherence was assessed by MPR: low <80%, medium 80–89%, high ≥90%. bChi-square test for categorical variables. cKruskal–Wallis test.
Abbreviations: GAD-7, 7-item Generalized Anxiety Disorder scale; PHQ-9, 9-item Patient Health Questionnaire; SF-12, 12-item Short Form Health Survey; PCS, physical component summary; MCS, mental component summary; IQR, interquartile range.
Influencing Factors of Psychological Burden
Multivariate logistic regression analysis indicated that employment status significantly reduced the risk of psychological burden by 51.0% (odds ratio [OR] = 0.49, 95% confidence interval [CI]: 0.28–0.87; P=0.014). In addition, each 5-point increase in the SF-12 PCS score was associated with 51% lower odds of psychological burden (OR=0.49, 95% CI: 0.38–0.62, P<0.001). No significant associations were identified with resistance, and treatment failure (Figure 2A). These findings suggest that functional status and physical well-being are more influential factors in psychological burden than treatment-related factors (Univariate analysis was presented in Table S1).
Figure 2.
Forest plots of the multivariable logistic regression models. (A) Factors associated with psychological burden. (B) Factors associated with medication adherence. Squares indicate odds ratios (ORs) and horizontal lines indicate 95% confidence intervals (CIs), the dashed red line marks or = 1. ORs for TKI therapy duration and physical component summary (PCS) score are scaled per 5 years and per 5 points, respectively. Blue denotes associations whose 95% CI excludes 1.
Influencing Factors of Medication Adherence
Therapy duration, line of treatment, and psychological burden demonstrated significant associations with medication adherence (Figure 2B). Specifically, each additional 5 years of TKI therapy was associated with 32% lower odds of adequate adherence (OR=0.68, 95%CI: 0.53–0.86, P=0.001). Patients receiving second-line therapy exhibited significantly poorer adherence compared to first-line counterparts (OR=0.55; 95% CI: 0.32–0.93; P=0.025). Though reduced adherence was observed in third-line therapy, this difference lacked statistical significance (OR=0.66; 95% CI: 0.35–1.21; P= 0.178). Patients with elevated psychological burden had 76.0% lower adherence odds (OR=0.24; 95% CI: 0.13–0.44; P<0.001, univariate analysis was presented in Table S2).
Discussion
This study provides a comprehensive exploration of the psychological health status of patients with CML and its relationship with treatment adherence and efficacy, revealing important findings that have significant implications for the management of CML.
Anxiety and depression are prevalent among patients with hematologic malignancies,23–25 and the rates in our cohort far exceed those of the Chinese general population: a 2023 multi-city survey (N=32,365) reported an 8.29% prevalence of moderate-to-severe depression (PHQ-9≥10),26 and a Guangdong study of 16,377 residents documented a 5.2% 12-month prevalence of generalized anxiety disorder (GAD-7≥10).27 This excess is consistent with the disproportionate psychological burden of chronic cancer populations, driven by disease chronicity, treatment-related stressors, and uncertainty about long-term outcomes. QoL showed a parallel pattern. Relative to US general population norms (50±10),28 the PCS and MCS deficits did not reach the conventional 5-point minimal clinically important difference (MCID), however, compared with the general adult population of Shanghai29—a more appropriate same-culture reference—both the PCS (5.5-point deficit) and MCS (7.7–8.2-point deficit) gaps exceeded the MCID, with mental health more impaired than physical health. Comparisons with Chinese adolescents20 are limited by age-structure disparities, but the contrast with HIV patients on lifelong efavirenz-based therapy30 is striking: CML patients reported inferior physical and mental health, challenging the entrenched perception of CML as a readily “manageable” condition in the TKI era. Together with the high psychological comorbidity, these findings consistent with a growing literature,31,32 suggest that the psychosocial needs of CML patients may be systematically underestimated, and they provide baseline data to inform psychological screening protocols in Chinese CML programs.
The central finding is the strong inverse association between psychological burden and adherence: affected patients had 75.9% lower odds of adequate adherence, and the association persisted after adjustment for treatment duration and line, suggesting that burden is an independent correlate rather than an epiphenomenon of treatment history. Clinically, efforts to improve adherence should therefore incorporate patients’ psychological well-being: individuals with significant burden could be offered individualized and accessible support, such as medication reminders, peer-support programs, adherence education combined with psychological counseling, and more frequent follow-up assessments. Because good adherence is central to achieving optimal treatment goals,33,34 addressing psychological burden may indirectly protect treatment outcomes.
Several findings indicate where such support should be targeted. Psychological burden did not differ between imatinib and second-generation TKIs, notably patients receiving the newer agents flumatinib (22.6%) or olverembatinib (1.9%) showed no lower burden than those on earlier-generation drugs. Advances in TKI design, which have progressively reduced physical toxicity, have not necessarily relieved the psychological weight of living with CML: fear of relapse or progression, the financial strain of ongoing and often costlier therapy, and the burden of a lifelong cancer diagnosis appear to persist independently of pharmacological refinement. Likewise, treatment duration was not correlated with burden, indicating little cumulative psychological wear from prolonged therapy per se. In contrast, employment and better physical health (higher SF-12 PCS) were protective. Employment supports economic security, social identity, and daily structure, helping to preserve self-worth,35 yet 75 patients in our cohort reported losing job opportunities because of their diagnosis. For patients willing and physically able to work, healthcare institutions, employers, and social security systems should explore collaborative models that provide workplace flexibility and medical support. Higher PCS scores reflect less pain and fewer physical limitations—an important buffer against psychological distress36—making physical-health management and vocational stability the two most actionable levers identified in this cohort. The observed associations should also be interpreted in light of potential bidirectionality and common-cause confounding. Poor perceived physical health (lower SF-12 PCS) and job loss were themselves associated with greater psychological burden in our cohort, and either could independently impair adherence—through physical incapacity, financial strain, or disrupted daily routines—rather than acting solely upstream of psychological distress. Conversely, non-adherence and the anxiety of anticipated disease progression may in turn aggravate psychological burden. Our cross-sectional data cannot disentangle these pathways; prospective studies with serial assessments are needed to establish whether treating psychological burden alone improves adherence, or whether effective interventions must simultaneously target physical health, vocational stability, and social support.
Longer TKI duration was cross-sectionally associated with poorer adherence, a pattern consistent with, though not proof of, medication fatigue, as widely reported in chronic diseases:37 asymptomatic patients on lifelong therapy gradually relax their vigilance. Adherence also deteriorated across treatment lines, plausibly reflecting diminished therapeutic confidence after prior failures and cumulative AEs, the non-significant third-line estimate likely reflects limited subgroup power. Notably, although burden was strongly associated with non-adherence, it showed no significant association with treatment failure or resistance. Three explanations may account for this dissociation. First, the adherence level required to maintain molecular control may exceed the ≥80% cutoff used here, so the non-adherence captured may not have been severe enough to produce measurable failure within the observation window. Second, molecular outcomes in this cohort were predominantly favorable, limiting statistical power for outcome comparisons. Third, current psychological status may reflect recent adherence behavior rather than the cumulative adherence history that determines molecular response. This dissociation cautions against claiming that psychological intervention will directly improve molecular outcomes, such a link, while biologically plausible and supported by indirect evidence from other cancers, remains to be demonstrated in CML.
This study has several limitations. Its cross-sectional design precludes causal inference and cannot capture longitudinal adherence trajectories, medication-fatigue dynamics, or the temporal direction of the burden–adherence association, the findings should be considered hypothesis-generating. Recruitment through an online single-center survey likely over-represents urban, digitally literate, follow-up-adherent patients, limiting generalizability to rural or digitally underserved populations. Self-reported psychological scales are subject to recall and social-desirability bias, future work should incorporate objective measures such as electronic monitoring. Unmeasured confounders—TKI toxicity severity, economic burden, and social support—may partly account for the burden–adherence association, for example, severe AEs could simultaneously increase distress and reduce adherence, generating a spurious link. Most importantly, whether treating psychological burden improves adherence can only be established by randomized or pragmatic interventional studies evaluating routine GAD-7/PHQ-9 screening coupled with psychological referral, a necessary step before such screening can enter guidelines. Finally, TDM was used only to adjudicate discrepant cases rather than systematically, routine TDM in future studies would provide an objective pharmacokinetic benchmark for adherence classification and further validate the dual-method approach.
Conclusion
This study shows that psychological burden is prevalent among Chinese patients with CML on TKI therapy and is strongly associated with impaired QoL and reduced medication adherence, but not with treatment failure or resistance, whether reducing burden improves molecular outcomes requires prospective confirmation. Employment status and perceived physical health emerged as key protective factors against psychological burden, suggesting that vocational support and proactive symptom management are no less important than psychological intervention itself. We therefore support integrating routine psychosocial screening with multidimensional support into CML follow-up, to be evaluated in prospective controlled studies. As treatment-free remission (TFR) is increasingly pursued, future studies incorporating TFR cohorts are warranted to disentangle disease-related distress from therapy-specific burden and to inform tailored psychosocial support across the full spectrum of CML management.
Funding Statement
There is no funding to report.
Data Sharing Statement
All data relevant to the study are included in the article or uploaded as supplementary information.
Ethics Approval and Consent to Participate
The study received approval from the Institutional Ethics Committee of Tongji Medical College (Wuhan, China; Approval No. 20250236). All participants provided written informed consent prior to completing the questionnaire.
Disclosure
The authors declare that there is no conflict of interest.
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Data Availability Statement
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