A multidisciplinary comfort-enhanced recovery after surgery program improves perioperative patient-reported outcomes after lung cancer surgery: a randomized controlled trial.

Introduction
Lung cancer is one of the most prevalent and deadly types of tumors worldwide (1). Surgical resection remains the primary treatment for early-stage lung cancer (2). A single high-volume thoracic center in China reported exceeding 20,000 annual surgeries in 2021 (3). Enhanced recovery after surgery (ERAS) has been implemented in China for more than two decades, effectively reducing perioperative risk and facilitating early recovery (4). European Society of Thoracic Surgeons (ESTS) and the ERAS Society jointly published guidelines in 2019, recommending evidence-based elements to minimize surgical stress and maintain physiological function (5). Numerous studies and meta-analyses have confirmed that adherence to ERAS pathways in lung surgery significantly reduces the length of hospital stay (LOS) and postoperative pulmonary complications (PPCs) without increasing readmission rates (6-9). However, while traditional ERAS protocols excel in improving objective clinical outcomes, such as complication rates, LOS, and costs (10,11), they often prioritize physiological recovery and healthcare efficiency over patient-reported experiences, particularly perioperative comfort.
Perioperative lung cancer patients may experience a range of discomfort. Studies indicate that 50–70% of patients report moderate to severe postoperative pain (12), approximately 27% develop adverse emotional states such as anxiety (13), and nearly 90% are troubled by symptoms such as coughing after surgery (14). These discomforts directly undermine patients’ confidence in recovery and diminish their perioperative quality of life (QoL) (15). The World Health Organization (WHO) recognizes that in assessing healthcare quality, patient-perceived quality of care is equally important to clinical effectiveness and patient safety (16). Patient comfort, as one of the important outcomes of a positive patient experience, should be prioritized in the ongoing development of ERAS protocols.
Comfort is commonly defined as a self-perceived state of ease, satisfaction, and freedom from anxiety and pain, reflecting holistic well-being (17-19). Kolcaba’s theory of comfort conceptualizes this state across four domains: physical, psychospiritual, sociocultural, and environmental (20). Therefore, efforts to increase perioperative comfort in lung cancer patients should extend beyond the management of physical discomfort, such as pain, to include active interventions targeting psychospiritual well-being and the provision of sociocultural support.
Perioperative comfort has gained increasing recognition in clinical practice. Evidence indicates that increased comfort not only reduces negative emotional states such as postoperative anxiety and depression but also contributes to lower complication rates, accelerated recovery, shortened hospital stays, and improved patient satisfaction (21,22). Furthermore, as perioperative comfort is a subjective experience reported by patients themselves, it necessitates multidimensional interventions tailored to individual needs such as pain management, nutritional support, rehabilitation, and psychological well-being throughout the surgical journey (23). To ensure the effectiveness of comfort management measures, it is essential to establish multidisciplinary team collaboration with clearly defined roles and responsibilities while also optimizing the perioperative patient management process (24).
Currently, perioperative comfort is seldom designated as a primary outcome in lung cancer research. Moreover, intervention protocols are frequently implemented unilaterally by nursing staff (25,26), with limited integrated multidisciplinary participation, which constrains the effectiveness of these interventions. Therefore, this study aims to design and implement a comfort-enhanced recovery after surgery (ComERAS) protocol for patients undergoing lung cancer surgery and to evaluate its efficacy through a randomized controlled trial (RCT). This approach aims to increase perioperative comfort and satisfaction, thus strengthening the “patient-centered” dimension of the ERAS framework and generating evidence to inform broader clinical implementation. We present this article in accordance with the CONSORT reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-aw-2170/rc).

Methods

Study design and ethics
This study was designed as a single-center, two-arm, single-blind RCT. Participants were patients scheduled to undergo lung cancer resection at a tertiary hospital in Sichuan, China. Subjects in the intervention group received a ComERAS Program, whereas those in the control group received standard perioperative care according to ERAS guidelines. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the ethics committee of West China Hospital, Sichuan University (No. 20231730, approval date: November 2, 2023) and informed consent was obtained from all individual participants. The study protocol was retrospectively registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2500109153, registration date: September 12, 2025).
Patients were involved in the development of the outcome measures. Specifically, the items of the self-designed satisfaction questionnaire were derived from a preliminary survey of lung cancer patients to ensure relevance and clarity. However, patients were not involved in the recruitment or conduct of the study. Results will be disseminated to participants upon request.

Participants
Participants were recruited from West China Hospital, Sichuan University from January to August 2024, with follow-up concluding in September 2024. The inclusion criteria were as follows: (I) scheduled to undergo video-assisted thoracoscopic surgery (VATS) or open lung resection for lung cancer; (II) aged 18–80 years; and (III) voluntary participation with signed informed consent.
The exclusion criteria were as follows: (I) severe cognitive impairment, defined as a Short Portable Mental Status Questionnaire (SPMSQ) score ≥8 (27,28); (II) current participation in other interventional clinical trials; and (III) significant comorbidities, including a history of other malignancies within the past 5 years or angina pectoris, myocardial infarction, or stroke within the previous 6 months.

Randomization and blinding
Researcher A assessed patient eligibility and obtained written informed consent. Researcher B generated the random allocation sequence at a 1:1 ratio via a computer-generated random sequence created via an online randomization service (https://www.randomizer.org/) and prepared sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. Researcher A opened the envelopes sequentially after baseline assessment. Upon allocation, the recruitment staff (Researcher A) and intervention providers were aware of group assignments, whereas the outcome assessors and data analysts remained blinded to allocation. The outcome data were collected by two researchers who were not involved in clinical care and were blinded to group assignment.

Intervention

Intervention group
Guided by Kolcaba’s comfort theory, we enhanced a conventional ERAS protocol into a comprehensive ComERAS program. A multidisciplinary team—comprising thoracic surgeons, advanced practice nurses, physical therapists, nutritionists, traditional Chinese medicine (TCM) practitioners, and “Sunshine Angel” mental health nurses—collaboratively delivered the intervention. The ComERAS program incorporated several structured components, including preemptive multimodal analgesia (PMA), a “minimal-tube” strategy, early postoperative feeding and mobilization, and TCM-based supportive therapies. To ensure consistency and reproducibility, the specific procedures, timing, and technical details of each component (e.g., the intraoperative intercostal nerve block used in PMA) are provided in Table 1, which outlines the full standardized ComERAS protocol. These integrated strategies were designed to increase patient comfort across the physiological, psychospiritual, sociocultural, and environmental domains throughout the perioperative period.

Control group
The control group received standard ERAS care, which aligned with the core principles of the Guidelines for enhanced recovery after lung surgery recommended by the ERAS® Society and ESTS (5), with institutional adaptations consistent with routine clinical practice at the Lung Cancer Center of West China Hospital, Sichuan University. This included preadmission education, standard perioperative management, predischarge guidance, and follow-up via either outpatient visits or telephone calls one month after discharge. Patients in both the intervention and control groups were managed by the same medical team to ensure consistency. Detailed interventions for both groups are presented in Table 1.

Standardization, quality control, and adherence
To ensure the reproducibility and strict definition of the intervention, a comprehensive Manual of Operations (MOP) was established prior to the study. This manual detailed the standard operating procedures (SOPs) for all core components of the ComERAS strategy. To monitor adherence to the protocols, specific checklists designed for each group were completed daily. To ensure objectivity, this process was conducted by a research nurse who was not involved in the direct clinical care of the participants. Key performance indicators (e.g., timing of mobilization, adherence to analgesic schedules, and tube management) were recorded. Any deviations from the protocol were documented and reviewed by the principal investigator to ensure the fidelity of the intervention.

Measurements

Clinical characteristics
A self-designed questionnaire was used to gather sociodemographic data, including sex, age, profession, educational level, and clinical characteristics, such as the type of surgery, LOS, and hospitalization costs.

Comfort
The General Comfort Questionnaire (GCQ), adapted by Jiang et al. and based on the Kolcaba General Comfort Questionnaire, was specifically designed to estimate the comfort levels of postoperative lung cancer patients (29,30). The scale consists of three dimensions, self-care ability, postoperative symptoms, and psychological state, encompassing a total of 10 items. It involves various aspects, including eating, dressing, early ambulation, bowel movements, coughing, pain, sleep, fatigue, dizziness, and negative emotions. Each item was rated on a scale from 0 to 2 points, with a higher cumulative score indicating a greater level of comfort.

Satisfaction
A self-developed satisfaction questionnaire consisting of six items was used to assess overall satisfaction, pain control, mobility, psychological support, the medical environment, and symptom management. Each item was rated on a 0–10 numerical rating scale, where ‘0’ indicated “not at all satisfied” and ‘10’ indicated “extremely satisfied”. Higher scores reflected greater satisfaction in each respective area.

Psychological status
The Hospital Anxiety and Depression Scale (HADS) was adopted, which includes two subscales for anxiety and depression, each with seven items, for a total of 14 items (31). subscale score of 8 or higher illustrates the presence of anxiety or depression, with higher scores corresponding to more severe symptoms (32).

QoL
QoL was assessed via the Quality of Life Questionnaire-Core 30 (QLQ-C30) core questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC) (33). The EORTC QLQ-C30 consists of 30 items that cover symptomatology, functional status, and overall QoL dimensions. Scores were standardized and transformed to a scale ranging from 0 to 100, where higher scores in the symptom dimension indicated more severe symptoms, and higher scores in the functional dimension represented better functioning (34).

Primary and secondary outcomes
In our study, the primary outcome was comfort score. The secondary outcomes included (I) postoperative outcomes: complications, intensive care unit (ICU) admits, hospital length of stays, and chesttube time; (II) the EORTC QLQ-C30 score for QoL; (III) the HADS score for psychological status; (IV) self-developed satisfaction questionnaire score for intervention satisfaction.

Sample size estimation
The sample size was determined for the primary endpoint of postoperative comfort, using a two-sample, two-sided t-test with 1:1 allocation. Based on previous study in cancer patients undergoing surgery (35,36), we assumed a within-group standard deviation (SD) of 19 points and targeted a clinically relevant between-group difference of 10 points (Cohen’s d ≈0.52, i.e., a moderate effect). With a two-sided alpha level of 0.05 and 80% power, the required size was 56 participants per group (112 total), as computed in G*Power 3.1. Allowing for an anticipated 20% attrition, the planned enrollment was 140 participants (70 per group).

Data collection
Data collection was conducted by two qualified research assistants who were unaware of the group assignments. Baseline data (T0) were collected prior to the intervention. Comfort, satisfaction, psychological state, and QoL were assessed on the day of discharge (T1). Comfort, psychological state, and QoL were reassessed 30 days post-discharge (T2). In-hospital assessments were conducted face-to-face, while the 30-day follow-up comprised both in-person outpatient visits and telephone interviews. During telephone follow-ups, research assistants asked each question sequentially and recorded the responses. Immediately after completing the questionnaire, they verified and corrected any errors or omissions.

Statistical analysis
All randomized participants were included in the intention-to-treat (ITT) analysis, and mixed-effects models accommodated missing data under a missing-at-random assumption. The Shapiro-Wilk test was used to assess the normality of continuous variables. Continuous variables are presented as the mean ± SD for normally distributed data or as the median and interquartile range (IQR) for nonnormally distributed data. Baseline characteristics were summarized via descriptive statistics. GCQ is postoperative only and was therefore not assessed preoperatively. For GCQ, we fitted a linear mixed-effects model with fixed effects for group (ComERAS vs. ERAS), time (T1, T2) and group × time, plus a random intercept for participants. To verify the robustness of the findings against the influence of surgical approach, a sensitivity analysis was performed by repeating the mixed-effects model in the subgroup of patients restricted to VATS (excluding those who underwent open thoracotomy or conversion to open surgery). For multi-timepoint scales assessed pre- and postoperatively (e.g., EORTC QLQ-C30, HADS), we analyzed changes from baseline using linear mixed-effects models with fixed effects for group, time (T1, T2), and group-by-time interaction, along with a random intercept. We reported the between-group differences in change with 95% confidence intervals (CIs). Missing data were minimal and handled under the missing-at-random assumption inherent to mixed models. Analysis of covariance (ANCOVA) at each time point served as sensitivity analyses. All tests were two tailed, with statistical significance defined as P<0.05. Analyses were performed in Stata 18.0 with maximum likelihood and robust standard errors.

Results

Patient demographics
From February to September 2024, a total of 141 patients scheduled for lung cancer surgery were assessed for eligibility. Of these, seven were excluded owing to refusal to participate (n=3), not meeting inclusion criteria (n=3) or cancellation of surgery (n=1). Accordingly, 134 patients were enrolled and randomly assigned to either the ERAS group or the ComERAS group (Figure 1). In total, 121 patients completed 1-month follow-up. The baseline characteristics are summarized in Table 2, with no significant between-group differences, confirming balanced randomization.

Surgical characteristics and postoperative outcomes
Surgical procedures were well-balanced between the two groups (Table 3). The majority of patients underwent anatomic resections (lobectomy or segmentectomy), accounting for 81.7% of the ERAS group and 82.0% of the ComERAS group.
Intraoperative characteristics were comparable: the median operative time was 75.0 (IQR, 58.0–115.0) min in the ComERAS group vs. 72.0 (IQR, 52.0–106.0) min in the ERAS group (P=0.38). Intraoperative blood loss was similar in both groups (P=0.69).
Regarding postoperative recovery, the ComERAS group demonstrated a significantly shorter duration of chest tube drainage compared to the ERAS group [34.0 (IQR, 25.0–45.0) vs. 47.0 (IQR, 29.0–68.0) h; P=0.002]. However, no statistically significant differences were observed in the LOS (P=0.06), ICU admission rates (P=0.56), or postoperative complications (P=0.10).

Effects on comfort scores
Patient partner feedback led to adopting comfort (GCQ) as the prespecified primary endpoint, streamlining chest tube removal criteria, and revising patient education materials; these changes were implemented before enrollment. The ComERAS group showed significantly higher adjusted comfort at discharge [+1.05; 95% confidence interval (CI): 0.26–1.84; P=0.01] and at 1-month follow-up (+0.57; 95% CI: 0.16–0.98; P=0.006) vs. the ERAS group, indicating better overall comfort (Table 4; Figure 2A). To verify the robustness of these findings against the influence of surgical approach, a sensitivity analysis was performed by excluding patients who underwent open thoracotomy. The results confirmed the efficacy of the intervention: in the VATS-only cohort, the ComERAS group demonstrated a significant improvement in comfort at discharge compared to the control group (+1.39; 95% CI: 0.78–1.99; P<0.001). In terms of self-care ability, the ComERAS group scored higher than the ERAS group did at discharge, indicating milder functional impairment and earlier recovery, although no differences were observed between the two groups at 1 month (Figure 2B). In terms of symptoms, including defecation, coughing, pain, sleep, fatigue, and dizziness, the ComERAS group scored higher than the ERAS group did at discharge, indicating a lighter symptom burden (Figure 2C-2H). At 1 month, differences in defecation and dizziness were no longer observed, but the ComERAS group continued to show higher scores for coughing, pain, sleep, and fatigue, suggesting sustained advantages in these domains. For negative emotions, where higher scores represent better mood, the ComERAS group scored higher than the ERAS group did at both discharge and 1 month (Figure 2I).

Effects on QoL, anxiety and depression
Most participants completed preoperative, discharge, and 1-month assessments of QoL anxiety and depression; mixed-effects models used all available observations under a missing-at-random assumption. At baseline, the QoL and HADS scores did not differ significantly between the two groups (Table 1, Table S1). In mixed-effects models of change from baseline, ComERAS produced clinically and statistically meaningful gains in emotional functioning at discharge (7.624; 95% CI: 3.054–12.194) and at 1 month (9.581; 95% CI: 5.307–13.855). Statistical differences in QoL, anxiety and depression between groups were assessed via mixed-effects repeated measures analysis, as shown in Table 5. At discharge and at the 1-month follow-up, ComERAS was associated with significant improvements in emotional functioning, with scores of 8 points and 10 points, respectively. Global health status/overall QoL favored ComERAS at 1 month (5.917; 95% CI: 0.677–11.157). Anxiety (HADS-A) decreased more under ComERAS at both discharge (−5.18; 95% CI: −8.290 to −2.070) and 1-month (−7.541; 95% CI: −10.997 to −4.085), whereas depression (HADS-D) changes were not significant. All other between-group differences were not statistically or clinically significant.

Effects on satisfaction
Compared with the ERAS group, the ComERAS group demonstrated significantly higher overall satisfaction, pain control, mobility, psychological support, and symptom management scores during hospitalization (P<0.05), as detailed in Table 6. The findings were robust to ordinal/nonparametric analyses accounting for ceiling effects.

Discussion

Key findings
This randomized, single-blind trial shows that a comfort-enhanced, multidisciplinary ERAS bundle (ComERAS) leads to consistently better patient-reported outcomes than standard ERAS for lung cancer surgery. Benefits were evident at discharge and persisted to 1 month, covering overall perioperative comfort (primary endpoint) and extending to pain control, sleep quality, emotional functioning, health-related QoL, and satisfaction. Importantly, the observed benefits carried substantial clinical relevance. Analysis of the primary outcome yielded a medium effect size (Cohen’s d ≈0.48) (37,38), indicating a meaningful shift in patient comfort beyond mere statistical significance. This is further corroborated by the reduction in anxiety scores (5.18–7.54 points), which exceeded the established minimal clinically important difference (MCID) of 1.5–2 points typically derived from distribution-based estimates for the HADS (39). These findings support positioning “comfort” as a prespecified clinical goal capable of delivering broad, patient-important gains early after surgery.

Strengths and limitations
There are several notable strengths in this study. The multidisciplinary design ensured close coordination among surgical, anesthetic, nursing, and rehabilitation teams, thereby enhancing the fidelity of intervention delivery. Moreover, the inclusion of culturally adapted adjuncts, such as TCM-based symptom management, provides practical insight for patient-centered adaptation in Chinese clinical settings.
However, certain limitations warrant caution. First, the single-center design and modest sample size may limit the generalizability of findings. Second, the single-blind procedure introduces potential performance bias. Third, as ComERAS represents a bundled intervention, it is difficult to isolate the contribution of individual components. Finally, the multiple secondary endpoints increase the risk of type I error, and the results should thus be interpreted as exploratory and hypothesis-generating.

Comparison with similar research
These results align with and extend prior thoracic ERAS literature. The existing recommendations emphasize multimodal, opioid-sparing analgesia, early chest tube removal, early mobilization, and respiratory training as contributors to faster recovery and fewer complications (40). Compared with systemic regimens, trials and reviews of regional techniques (e.g., intercostal or paravertebral blocks) have reported superior analgesia and fewer opioid-related adverse effects, and structured mobilization and breathing exercises are associated with better pulmonary recovery and patient-reported outcomes (41,42). The present research advances the field by placing perioperative comfort as the prespecified primary endpoint within a randomized design and by operationalizing a bundle that integrates comfort-sensitive processes (analgesia, tubing, mobilization/airway care) with psychological and educational support under explicit multidisciplinary governance.

Explanations of findings
Optimized analgesia—including a preemptive, multimodal regimen with a regional component—likely enables more effective coughing and adherence to airway-clearance techniques, reduces movement-related pain, and facilitates earlier mobilization; these behavioral changes plausibly mitigate discomfort, sleep disruption, and negative affect, thereby increasing perceived comfort and QoL (43). In parallel, a minimal-tube strategy reduces restraint-related discomfort and physical barriers to activity, whereas structured education, psychological support, and family involvement address cognitive-emotional needs that are tightly coupled with patients’ subjective experience of recovery (44,45). In our study, adjunctive TCM-based symptom management, such as ointments and herbal compresses, was integrated as a culturally acceptable option to address nausea, cough, constipation, and other bothersome symptoms (46); although the evidence base for specific components is heterogeneous, the directional consistency of improvements across multiple patient-important outcomes suggests that a comfort-prioritized bundle can be effective when it is delivered with multidisciplinary coordination.

Implications and actions needed
From an implementation standpoint, ComERAS offers a replicable operational template: role-defined team responsibilities; daily coordination led by a comfort-focused care manager; and process targets for analgesia, mobilization, respiratory practice, and tubing. For scale-up beyond high-resource centers, attention to reach, fidelity, and maintenance is critical (47). The incorporation of electronic patient-reported outcomes, simple bedside checklists or dashboards, and automated prompts for respiratory practice and ambulation may reduce workflow burden and sustain adherence (48). Site-specific adaptation (e.g., availability of regional anesthesia, rehabilitation and psychological services, or culturally specific adjuncts) should be anticipated. The ComERAS framework is designed as a flexible template rather than a rigid protocol. While our study utilized TCM-based interventions (e.g., herbal compresses) effectively within a Chinese cultural context, these specific components serve as placeholders for ‘comfort-enhancing adjuncts’ and can be substituted in other healthcare settings. For instance, centers in other regions might substitute TCM with culturally congruent alternatives such as mindfulness-based stress reduction, music therapy, or aromatherapy. The core mechanism of ComERAS—prioritizing patient comfort through multidisciplinary governance—is universal and transferable, regardless of the specific local modalities employed to achieve it. Future work should prioritize multicenter pragmatic randomized trials to test their external validity across diverse hospitals and patient demographics. Second, component-dismantling or factorial designs could be employed to identify active ingredients and optimize bundle efficiency. Moreover, longer-term follow-up is needed to determine the persistence of comfort gains and potential downstream effects on complications, readmissions, functional recovery, and return to normal activities. From a policy perspective, we recommend integrating “comfort” as a key indicator in hospital quality assessment systems to facilitate a shift in perioperative care from emphasizing “medical safety” to truly prioritizing “patient experience” (49).

Conclusions
This study demonstrated that a comfort-enhanced multidisciplinary protocol significantly improved perioperative comfort, emotional function, QoL, and satisfaction among patients who underwent lung cancer surgery during the first postoperative month. The proposed model not only expands the core principles of ERAS but also offers empirical evidence and a practical framework for shifting perioperative care from a “medicine-centered” approach to a “patient-experience-centered” approach. The current findings support the immediate value of prioritizing patient comfort. More clinical studies on extended follow-up, multicenter validation, identification of active components and economic evaluations are needed.

Supplementary
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