This study protocol adheres to the ethical principles set forth in the Declaration of Helsinki and has been approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Approval No.: SG-2025-091; date of approval: August 5, 2025). The Ethics Committee formally waived the requirement for informed consent because the study was retrospective and analyzed only archived clinical data, with all patient-identifiable information strictly anonymized. The approval covers the full data-collection window of the study (January 2022 to July 2025). The details of all the equipment and software used are listed in the Table of Materials.
Study design and participants
This retrospective cohort study included patients with renal failure complicated by malignancy who received maintenance hemodialysis at our hospital from January 2022 to January 2024. The data cut-off date for all follow-up assessments was July 31, 2025, ensuring that every enrolled patient had a minimum observational window of 18 months from baseline. Based on electronic medical records and nursing notes, patients were assigned to a control group (conventional hemodialysis nursing) or an observation group (conventional plus multimodal psychological nursing). Negative emotions, treatment compliance, quality of life, and psychological resources were compared at three time points: baseline (before psychological nursing), at 6 months (end of intervention), and at 18 months (12 months post-intervention) to assess long-term effects. A total of 431 patients were initially screened. Of these, 69 were excluded at baseline based on the predefined exclusion criteria, including severe cardiac, cerebral, or pulmonary insufficiency or other severe somatic diseases (n = 16), history of psychiatric disorders or severe cognitive dysfunction (n = 9), speech, hearing, or severe visual impairment (n = 7), participation in other psychological nursing studies or systematic psychotherapy within the past 3 months (n = 15), terminal stage of cancer or severe cachexia (n = 12), and irregular hemodialysis treatment or undergoing peritoneal dialysis or kidney transplantation (n = 10). The remaining 362 eligible patients were followed for 18 months, during which 87 were further excluded due to incomplete clinical records or missing questionnaire data at any time point (n = 48), loss to follow-up before the 18-month assessment (n = 22), or death during the observation period (n = 17). Exclusion rates were similar between the two groups. The final analytic cohort consisted of 275 patients (132 in the control group and 143 in the observation group) with complete data at all three time points. The assignment to groups was determined by the temporal implementation of a revised clinical nursing protocol: patients enrolled between January 2022 and March 2023 received conventional care (control group), while those enrolled between April 2023 and January 2024, following the hospital-wide rollout of the multimodal psychological nursing program, received the combined intervention (observation group). The study flow chart is shown in Figure 1.
Inclusion and exclusion criteria
Inclusion criteria: (1) Age 18-75 years; (2) Diagnosed with chronic renal failure, on regular hemodialysis for ≥3 months (2-3 sessions/week, 4 h each); (3) Confirmed diagnosis of malignant tumor by pathological or cytological examination, or cancer patients with a clear clinical diagnostic basis; (4) Conscious with basic literacy and language communication skills, able to independently complete questionnaire assessments; (5) Expected survival ≥18 months; (6) Complete clinical data, including baseline demographic information, questionnaire data, nursing records, and follow-up data; (7) Patients in the observation group had complete records of the 6-month multimodal psychological nursing, while patients in the control group had concurrent routine nursing records.
Exclusion Criteria: (1) Patients with severe cardiac, cerebral, or pulmonary insufficiency or other severe somatic diseases that preclude cooperation with assessment; (2) Previous history of psychiatric disorders or severe cognitive dysfunction; (3) Presence of speech, hearing, or severe visual impairment affecting questionnaire completion; (4) Participation in other psychological nursing studies or undergoing systematic psychotherapy within the past 3 months; (5) Terminal stage of cancer or severe cachexia; (6) Irregular hemodialysis treatment or undergoing peritoneal dialysis or kidney transplantation; (7) Incomplete clinical data or incomplete follow-up data.
Sample size calculation
This study is a retrospective cohort study, and the sample size was calculated based on previous literature17. Using the Self-Rating Anxiety Scale (SAS) score, the primary outcome measure, as a reference, an assumed effect size of Cohen's d = 0.4 was used, with a two-sided test was set with α = 0.05 and a power (1 - β) = 0.90. Using power-analysis software, the minimum required sample size was 118 patients per group. Considering the potential for 10%-15% missing data or data quality issues inherent in retrospective studies, it was ultimately determined that each group should have no fewer than 130 patients, with a total sample size of no less than 260 patients. A total of 275 patients were actually enrolled, including 132 in the control group and 143 in the observation group, meeting the sample size requirement. Notably, the observed post-intervention effect size for the SAS score (Cohen's d = 1.741) was larger than the estimate derived from the referenced literature. This discrepancy likely reflects differences in the study population and the intensity of the multimodal intervention. It should be noted that this sample size calculation and the post-hoc power analysis were performed after the data were analyzed, and therefore represent a post hoc justification rather than a prospective sample size estimation. Despite this, the achieved sample size still exceeded the minimum calculated requirement, and post-hoc power analysis confirmed that the final sample provided sufficient statistical power (>0.99) to detect the primary outcome. Therefore, the observed larger effect size does not compromise the validity of the sample size estimation.
Grouping method
Data were collected through medical record review at baseline (admission), at the 6-month time point (upon completion of the nursing intervention as documented in nursing records), and at the final follow-up (12 months post-intervention). The control group (n = 132) received routine hemodialysis nursing care, including assistance with dialysis treatment, vital signs monitoring, vascular access care, dietary guidance, medication education, and complication management. Nursing staff provided health education and psychological counseling according to standard procedures, without a systematic psychological nursing program. The observation group (n = 143) received, in addition to the routine care provided to the control group, a 6-month multimodal psychological nursing program. This program integrated three components: cognitive behavioral nursing, MBSR, and family support system construction.
Routine nursing protocol (both groups)
The control group received routine hospital hemodialysis nursing care, including monitoring of vital signs before, during, and after dialysis; vascular access care; dietary and fluid management guidance; medication guidance; health education and routine psychological comfort measures, such as listening, encouragement, and emotional counseling.
Multimodal psychological nursing protocol (observation group only)
The multimodal psychological nursing program lasted for 6 months (24 weeks) and integrated three components: (1) Cognitive Behavioral Nursing (Weeks 1-24): Based on cognitive behavioral therapy theory, systematic nursing care was provided targeting patients' maladaptive cognitions and negative automatic thoughts. The program comprised four phases delivered through 12 structured individual sessions: cognitive assessment and relationship building (Weeks 1-4, sessions 1-2), cognitive restructuring (Weeks 5-12, sessions 3-6, weekly 45-60 min individualized sessions), behavioral activation and coping training (Weeks 13-20, sessions 7-10), and consolidation and relapse prevention (Weeks 21-24, sessions 11-12). (2) Mindfulness-Based Stress Reduction (Weeks 1-24): Adapted from the classic Kabat-Zinn MBSR protocol, sessions were held twice weekly during dialysis (40 min/session), including mindful breathing (10 min), body scan (15 min), mindful meditation (10 min), and sharing (5 min). Patients were also instructed to practice mindful breathing for 15 min daily at home, with weekly nurse feedback via WeChat. (3) Family Support System Construction (Weeks 1-24): This component included family psychoeducation (Weeks 1-4), communication skills training (Weeks 5-12, monthly 90 min workshops), caregiver support groups (Weeks 13-20, monthly 120 min sessions), and family resource linkage (Weeks 21-24).
Treatment fidelity verification
To retrospectively verify treatment fidelity, we reviewed standardized nursing records and electronic medical records for three core components. A complete intervention was defined as ≥80% adherence across all components-specifically, participation in at least 10 of 12 cognitive sessions, ≥38 of 48 MBSR sessions, and completion of all three family support phases. Of the 187 patients allocated to the observation group, 14 failed to meet this 80% threshold; these patients were excluded from the final analysis and were included among the 48 patients excluded for incomplete records or missing questionnaire data. The program was delivered by five registered nurses (each with ≥5 years of hemodialysis experience) who completed a 40 h certified training in cognitive behavioral nursing and MBSR, under senior clinical psychologist supervision, with quarterly competency reassessments. Fidelity was independently checked by two research assistants against a predefined intervention checklist; disagreements were resolved by a third reviewer.
Clinical outcome measures
Data were collected through the electronic medical record system and nursing assessment records. All outcome measures were assessed at the following three time points: before nursing intervention (baseline), at the end of the nursing intervention (6 months), and 12 months after the end of the nursing intervention (18 months after baseline).
Negative emotions and psychological status
Self-Rating Anxiety Scale (SAS)18: Zung's 20-item, 4-point scale. Standard scores: <50 normal, 50-59 mild, 60-69 moderate, ≥70 severe anxiety.
Self-Rating Depression Scale (SDS)19: Zung's 20-item, 4-point scale. Standard scores: <50 normal, 50-59 mild, 60-69 moderate, ≥70 severe depression.
Distress Thermometer (DT)20: NCCN-recommended single-item 0-10 visual scale (0=no distress, 10=extreme distress).
Treatment adherence and self-management behaviors
Dialysis Treatment Adherence Questionnaire: The Treatment Adherence Scale for Maintenance Hemodialysis Patients21 assesses dietary, fluid, medication, and dialysis regimen adherence (0-100 scale; higher=better adherence).
Hemodialysis Patient Self-Management Behavior Questionnaire: The Chinese version of the Hemodialysis Patient Self-Management Behavior Scale22 has 20 items across four dimensions (problem-solving, self-care, partnership, emotional management), rated 1-4 (never to always). Total score 20-80; higher=stronger self-management.
Quality of life
Kidney Disease Quality of Life Short Form (KDQOL-36)23: Includes SF-12, Burden of Kidney Disease, Symptoms/Problems, and Effects on Daily Life. Each domain scored 0-100; higher=better QoL.
Psychological resources and coping
Herth Hope Index (HHI)24: 12 items, 4-point Likert scale (total score 12-48); higher scores indicate greater hope.
Connor-Davidson Resilience Scale (CD-RISC)25: 25 items across three dimensions (tenacity, strength, optimism), 5-point Likert scale (0-100); higher scores indicate better resilience.
Multidimensional Health Locus of Control Scale (MHLC)26: Only the Internality subscale (6 items, 6-point Likert scale) was used in this study, as it directly assesses the extent to which patients believe their health outcomes are determined by their own behaviors and efforts-a mechanism theoretically central to sustained treatment adherence and self-management. Higher scores indicate a stronger internal health locus of control.
Nursing satisfaction
Nursing satisfaction was assessed at the 6-month time point (end of the intervention) using a single-item, 4-level global rating scale (1 = dissatisfied, 2 = fair, 3 = satisfied, 4 = very satisfied). The scale was designed to be concise and practical for routine clinical use, and its framework was consistent with the approach described by Cheng and Lai27. We acknowledge that this single-item measure lacks formal psychometric validation therefore, these findings should be interpreted with caution, and future studies should use validated instruments to confirm them.
Statistical analysis
Statistical analyses were performed using statistical software. The normality of continuous variables was assessed using the Kolmogorov-Smirnov test combined with visual inspection of Q-Q plots. Normally distributed data are presented as mean ± standard deviation (SD), and non-normally distributed data as median with interquartile range (IQR). Categorical variables are expressed as frequencies and percentages and were compared using the chi-square test or Fisher's exact test, as appropriate. To evaluate longitudinal effects across three time points (baseline, 6 months [end of intervention], and 18 months [12-month follow-up]), we adopted a stratified approach based on data distribution. For normally distributed outcomes, we used repeated-measures ANOVA with group as the between-subjects factor and time as the within-subjects factor, focusing on the group × time interaction; the baseline value of the outcome and key covariates were entered as covariates. For non-normally distributed outcomes, we used generalized estimating equations (GEE). The primary outcome family was negative emotions (SAS, SDS, DT), measured at 6 and 18 months post-baseline, resulting in six between-group comparisons. Bonferroni correction was used for this primary family, with two-sided α = 0.05/6 = 0.0083. The remaining outcomes, including treatment adherence, self-management behaviour, KDQOL-36, psychological resources (HHI, CD-RISC, MHLC-Internality) and nursing satisfaction, were secondary exploratory endpoints. No multiplicity correction was performed for these exploratory outcomes; their p values are hypothesis-generating rather than confirmatory.