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Patients with esophageal cancer often experience clinically relevant deterioration of quality of life (QOL) after esophagectomy owing to malnutrition, lack of physical exercise, and psychological symptoms.
This study aimed to evaluate the feasibility, safety, and efficacy of a comprehensive intervention model using a mobile health system (CIMmH) in patients with esophageal cancer after esophagectomy.
Twenty patients with esophageal cancer undergoing the modified McKeown surgical procedure were invited to join the CIMmH program with both online and offline components for 12 weeks. The participants were assessed before surgery and again at 1 and 3 months after esophagectomy. QOL, depressive symptoms, anxiety, stress, nutrition, and physical fitness were measured.
Of the 20 patients, 16 (80%) completed the program. One month after esophagectomy, patients showed significant deterioration in overall QOL (
The CIMmH was feasible and safe and demonstrated encouraging efficacy testing with a control group for enhancing recovery after surgery among patients with esophageal cancer in China.
Chinese Clinical Trial Registry (ChiCTR-IPR-1800019900); http://www.chictr.org.cn/showprojen.aspx?proj=32811.
Esophageal cancer is the third most common cancer and the fourth most common cause of cancer death in China [
Enhanced recovery after surgery (ERAS) is a patient-centered, evidence-based multimodal and multidisciplinary approach for promoting early recovery and reducing complications among patients after surgery [
In addition, effective information delivery and adherence to follow-up with health care professionals are of high priority in cancer care and are key elements of successful implementation of ERAS. In the past, most interventions were delivered face-to-face in either individual or group settings [
Therefore, we designed the first comprehensive intervention model supported by mHealth (CIMmH) delivered on the WeChat platform, providing nutrition, exercise, and psychological support for patients with esophageal cancer after esophagectomy. This prospective pilot study aimed to examine the feasibility and safety of a 12-week CIMmH. The study will support the development of future programs for those patients with cancer who may not be able to visit the hospital frequently or who live in rural areas in China.
This prospective, single-arm, nonrandomized pilot study was conducted at the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China, which has 2850 beds serving 4.9 million patients each year. The Department of Thoracic Surgery cares for more than 300 patients with esophageal cancer each year. The study was registered at the Chinese Clinical Trial Registry (ChiCTR-IPR-1800019900) and was approved by the ethics committee of the First Affiliated Hospital of Sun Yat-sen University according to the Declaration of Helsinki.
Patients diagnosed with esophageal cancer and scheduled for esophageal radical resection were referred by thoracic oncologists in the inpatient department of the hospital from December 2018 to October 2019. Those who met the eligibility criteria were invited to join the study. The inclusion criteria of the study were a diagnosis of esophageal cancer, suitability for the modified McKeown procedure (thoracoscopic esophageal mobilization three-incision esophagectomy) [
CONSORT flow chart of the study.
A 3-month CIMmH program was delivered to participants after surgery by specialists in the hospital (offline) and through the enhanced WeChat platform (online). The program included general guidelines on postsurgery recovery, strategies to cope with postoperative complications, nutrition guidelines, physical exercise promotion, and psychological support courses. Details of the CIMmH are provided in
Components of the 3-month CIMmH program.
Category | Presurgery | Postsurgerya | |||
Week 1-2 | Week 1 (before discharge) | Week 2-3 (nasogastric tube removed) | Week 4-6 (nasogastric tube feeding tube removed) | Week 7-12 | |
General introduction | Introduction of the CIMmHb program (video by a doctor) | Introduction of the strategies to cope with common postoperative complications | Introduction of the strategies to cope with common postoperative complications | Introduction of the strategies to cope with common postoperative complications | Introduction of the strategies to cope with common postoperative complications |
Nutrition | N/Ac | Standard postoperative nutrition support in the hospital | Rehabilitation guidance of the jejunostomy feeding enteral nutrition period (video by a doctor and nurse) |
Rehabilitation guidance of the transitional period between enteral nutrition and ONSd (video by a doctor and nurse) |
Rehabilitation guidance of ONS and oral intake (video by a doctor and nurse) |
Physical exercise | Inspiratory muscle training | Walk promotion | Walk promotion | Walk promotion |
Walk promotion |
Psychological courses | N/A | N/A | N/A | Adapted MBCRe courses (articles and audio) | Adapted MBCR courses (articles and audio) |
Data collection | Data collection at baseline (ie, about 1 week before surgery) | N/A | N/A | Data collection at 1 month after surgery | Data collection at 3 months after surgery |
aPostoperative day (POD) 1: commence 20 mL/h water via jejunostomy feeding; POD 2: commence 20 mL/h jejunostomy feed enteral nutrition suspension; POD 3 to the date of discharge: gradually increase jejunostomy feed to the rate that meets the individual daily energy plan.
bCIMmH: comprehensive intervention model using the mobile health system.
cN/A: not applicable.
dONS: oral nutrition supply.
eMBCR: mindfulness-based cancer recovery.
Individual nutrition plans were developed by clinical nutritionists and cardiothoracic surgeons based on European Society of Clinical Nutrition and Metabolism guidelines (energy, 30 kcal/kg; protein, 1.5 g/kg ideal body weight) [
The physical exercise protocol consisted of inspiratory muscle training (chest mobilization exercise, flow-oriented incentive spirometry, deep breathing, and coughing exercise), walking exercise [
Baduanjin qigong has been shown to have positive effects on patients with cancer, including alleviating sleep disturbances, strengthening immune function, and improving QOL [
A psychological support program was adapted from mindfulness-based cancer recovery (MBCR) courses [
The enhanced WeChat platform was developed by the research team, with three enhanced functions, including automatic intervention delivery, progress monitoring of patient engagement, and personalized feedback with community support.
Through the enhanced WeChat platform, intervention materials were delivered to the participants and their family caregivers. In order to deliver the targeted intervention at different stages of recovery, the 3-month intervention was divided into the following five stages: (1) enrollment to presurgery; (2) after surgery and before discharge (POD 8); (3) after discharge until before removal of the nasogastric tube (POD 21); (4) before removal of the feeding tube (POD 42); and (5) after removal of the feeding tube until completion (POD 84). Researchers preset the stages for each patient on the online platform, and the corresponding intervention materials for each stage were automatically sent to the users.
Patient engagement was tracked and monitored by the enhanced mHealth system, which showed whether the participants had switched on the program and the length of time they stayed on it. In addition, the participants were asked to report their nutrition intake, duration of walking, frequency of practicing Baduanjin qigong exercise, and mood every day on WeChat. The patients received instant and automatic feedback through WeChat and phone calls when needed, to discuss how they had completed the CIMmH program and whether their intake met the nutrition needs.
An online support community was developed to offer social support through a chat feature. All participants were invited to join, and they were able to post their questions or comments on the WeChat group or via private chat to seek help or share their experiences. Researchers could also respond to messages instantly.
The participants were assessed at the following three time points: baseline (about 1 week before surgery) and 1 month and 3 months after surgery. The assessments were conducted in the hospital with the use of tablets and were assisted by trained research staff. Sociodemographic characteristics were collected, and they included age, gender, marital status, education, employment, and income. For measuring patient QOL, the European Organization for Research and Treatment of Cancer-Quality of life Question-Core (EORTC-QLQ-C30, version 3.0) and Oesophageal Cancer Module (EORTC-QLQ-OES-18) questionnaires [
EORTC-QLQ-OES-18 is a supplement of the disease-specific module for patients with esophageal cancer [
Descriptive analyses of the sociodemographic characteristics and health outcomes were conducted. Means and SDs were used to describe normally distributed continuous variables, while medians and IQRs were used for continuous variables that were not normally distributed, and proportions were used for categorical variables. Pre-post comparisons of outcomes between baseline and the 1-month follow-up and between baseline and the 3-month follow-up were conducted. Paired Student
In total, 95% (19/20) of the participants used the online program. Moreover, participants used the online program for an average of 71 minutes in total during the study period. Participants viewed on average 84% (3.38/4) of the online video intervention content and completed on average 14% (3.20/23) and 34% (9.44/28) of the online audio and article content, respectively. Participants completed on average 63% (5.01/8), 100.00% (1/1), and 24% (10.89/46) of the online nutrition, physical exercise, and psychological intervention content, respectively. There was no serious adverse event in any of the participants.
Participants’ sociodemographic and clinical characteristics are summarized in
Demographic and clinical characteristics of the study participants.
Characteristic | Participants (N=20), mean (SD) or n (%) | |
Age, years | 62.20 (7.10) | |
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Male | 18 (90) |
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Female | 2 (10) |
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City | 8 (40) |
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Rural | 12 (60) |
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Less than high school | 11 (55) |
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High school or greater | 9 (45) |
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Married | 20 (100) |
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Unmarried | 0 (0) |
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Yes | 19 (95) |
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No | 1 (5) |
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Retired | 12 (60) |
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Employed | 8 (40) |
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<3000 | 11 (55) |
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≥3000 | 9 (45) |
Smoking | 17 (85) | |
Drinking | 9 (45) | |
Kungfu tea drinking | 10 (50) | |
Regular exercise | 10 (50) | |
Cancer history | 9 (45) | |
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Not performed | 13 (65) |
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Performed | 7 (35) |
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Upper thoracic area | 4 (20) |
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Middle thoracic area | 10 (50) |
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Lower thoracic area | 6 (30) |
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I | 4 (20) |
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II | 6 (30) |
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III | 9 (45) |
a¥1 = US $0.14.
Overall QOL decreased significantly (
Participants’ nutrition status worsened after esophagectomy. Analyses of pre-post changes showed a significant decrease in weight (
There was no significant change in the 6MWD between baseline and the 1-month follow-up (
There was a significant increase in depressive symptoms from baseline to the 1-month follow-up (
Results of the outcome variables.
Outcome variables | Baseline score or valuea (N=20) | 1-month follow-up score or valuea (N=20) | 3-month follow-up score or valuea (N=16) | |||
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Overall quality of life scalec | 76.70 (17.40) | 65.40 (16.10)d | 69.80 (12.10) | |
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Physical functioning | 93.70 (12.30) | 84.00 (17.30) | 90.80 (8.20) |
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Role functioning | 80.00 (29.80) | 72.50 (23.70) | 74.00 (20.60) |
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Emotional Functioning | 86.70 (13.20) | 76.70 (26.00) | 85.40 (20.70) |
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Cognitive functioning | 94.20 (11.80) | 90.00 (18.10) | 92.70 (11.40) |
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Social functioning | 71.70 (25.80) | 70.80 (22.90) | 65.60 (25.90) |
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Fatigue | 10.00 (12.30) | 36.10 (19.70)g | 20.80 (23.10) |
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Nausea and vomiting scale | 5.00 (11.60) | 12.50 (22.90) | 5.20 (15.90) |
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Pain | 3.30 (6.50) | 15.80 (18.20)g | 12.50 (15.70)d |
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Dyspnea | 3.30 (14.20) | 25.00 (17.40)g | 20.80 (27.70) |
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Insomnia | 23.30 (32.70) | 30.00 (32.40) | 22.90 (35.60) |
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Appetite loss | 6.70 (22.10) | 20.00 (26.00) | 20.80 (27.70) |
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Constipation | 11.70 (21.30) | 13.30 (21.60) | 16.70 (28.00) |
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Diarrhea | 6.70 (13.00) | 13.30 (19.00) | 12.50 (15.70) |
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Financial difficulties | 36.70 (28.90) | 28.30 (33.00) | 29.20 (25.20) |
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Dysphagia | 68.30 (33.80) | 62.80 (27.50) | 68.10 (29.60) |
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Trouble swallowing saliva | 36.70 (44.70) | 31.70 (39.10) | 26.70 (37.60) |
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Choked when swallowing | 16.70 (28.20) | 23.30 (25.40) | 28.90 (33.10) |
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Eating | 6.70 (14.70) | 25.80 (18.20)g | 21.70 (16.40)d |
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Dry mouth | 20.00 (28.00) | 23.30 (25.40) | 6.70 (12.90)d |
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Trouble with taste | 5.00 (21.30) | 11.70 (23.60) | 2.20 (8.10) |
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Trouble with coughing | 11.70 (18.60) | 38.30 (33.00)d | 15.60 (20.00) |
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Trouble talking | 0.00 (0.00) | 43.30 (29.30)g | 17.80 (20.00)g |
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Reflux | 5.00 (14.60) | 23.30 (26.90)d | 25.60 (31.70) |
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Pain | 8.30 (14.10) | 10.60 (12.10) | 10.40 (13.30) |
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Weight (kg) | 60.00 (8.70) | 56.30 (7.80)g | 55.00 (8.00)g | ||
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BMI (kg/m2) | 21.50 (3.30) | 20.50 (2.60)d | 20.00 (2.60)d | ||
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6MWDi (m) | 506 (330.00-558.00) | 469 (276.00-612.00) | 486 (343.00-682.00) | ||
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6MWD changej | N/Ak | 0.95 (0.67-1.43) | 1.03 (0.83-1.24) | ||
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PHQ-9l | 1.11 (1.33) | 5.00 (4.61)d | 2.81 (3.56) | ||
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GAD-7m | 3.50 (4.16) | 4.20 (4.54) | 2.65 (3.52) | ||
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PSS-10n | 10.30 (4.54) | 12.60 (6.61) | 10.65 (7.03) | ||
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Depressed, n (%) | 0 (0) | 3 (15) | 1 (6) | ||
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Anxiety, n (%) | 4 (20) | 4 (20) | 2 (12) |
aData are presented as mean (SD), n (%), or median (range).
bEORTC-QLQ-C30: European Organization for Research and Treatment of Cancer-Quality of life Question-Core-30.
cHigher scores indicate better health.
d
eHigher scores indicate better function.
fHigher scores indicate worse symptoms.
g
hEORTC-QLQ-OES-18: European Organization for Research and Treatment of Cancer-Quality of life Question-Oesophageal Cancer Module-18.
i6MWD: 6-minute walk distance.
j6MWD change was calculated using follow-up 6MWD values divided by baseline 6MWD values.
kN/A: not applicable.
lPHQ-9: Patient Health Questionnaire-9.
mGAD-7: General Anxiety Disorder-7.
nPSS-10: Perceived Stress Scale-10.
At the end of the study, participants were asked about their experiences of the intervention through the WeChat platform. Of the 20 participants, 18 (90%) reported that they were satisfied with the intervention program. Some suggested that the intervention interface and content could be designed in a more interesting and attractive way. One patient suggested that more intervention programs should be delivered in video format. Eight patients reported that they would like to receive more information about effective strategies to cope with postoperative complications.
To the best of our knowledge, this prospective pilot study is the first attempt to develop and test the feasibility of an mHealth-based comprehensive intervention with nutrition, exercise, and psychological support through an online platform to help promote the ERAS program for patients with esophageal cancer.
For patients with cancer, ERAS is critical and challenging, as they experience both physical and mental complications. Tailor-made comprehensive interventions are needed for patients with specific cancers, as different types of cancers have different needs. Patients with esophageal cancer, for example, need special attention for nutrition intake and rehabilitation of respiratory movement after esophagectomy. The CIMmH is a comprehensive intervention addressing poor nutrition, physical inactivity, and intensified mental health symptoms within a single program for patients with esophageal cancer after surgery. The findings from this study indicate that the CIMmH is feasible and safe with no serious adverse effects for patients. The relevant decrease in overall QOL and increases in symptoms like fatigue, pain, dyspnea, difficulty with eating, trouble with coughing, trouble with talking, and reflux at the 1-month follow-up were expected, as patients were still in the recovery period after the surgery and were using feeding tubes. The results indicated that at the 3-month follow-up, except for pain, difficulty with eating, dry mouth, and trouble with talking, most of the QOL measures returned to the levels at the preoperative stage, indicating that recovery in these dimensions occurred 3 months after surgery. Compared with this study, previous studies that used traditional postoperative rehabilitation programs reported greater decreases in most functional dimensions of QOL and more serious deterioration of symptoms at 1 month and 3 months after surgery [
As surgical injury often worsens the nutritional status of patients with esophagectomy, decreases in body weight and BMI are expected and have been well documented [
Results of the 6MWD test at the 3-month follow-up demonstrated physical status comparable to that at baseline, indicating the effects of the CIMmH with regard to buffering the deterioration of physical fitness in patients after esophagectomy. Previous studies involving traditional postoperative rehabilitation showed a greater decrease in the 6MWD in the third month after surgery when compared with the finding in this study [
In this study, the mHealth system yielded a unique opportunity to provide much needed postsurgical care for the included patients. The functions of automatic monitoring, timely interventions, and feedback through the online mHealth system helped improve intervention adherence, as 80% (16/20) of participants completed the intervention. Although no formal qualitative data were collected in this study, some participants reported that they liked the video talks given by the medical doctors on how to take care of themselves and found the information on nutrition, exercise, and symptom management useful and helpful. In addition, professionals in the hospital reflected that the comprehensive intervention model of combining online (mHealth) and offline (face-to-face) services in this study was cost-effective and easier to incorporate into existing clinical practice and health care services, as less professional time was required and patients could receive tailor-made and timely interventions at home [
Patient engagement data indicated that online intervention content in video format was more popular than audio or written materials. One possible reason might be that most participants in this study were elderly people who might have found it easier to understand vivid videos compared with audio content and articles. Future interventions may consider using more intervention materials in video format. Moreover, the completed proportions of the online nutrition and exercise intervention content were much higher than the completed proportion of the psychological intervention content. One possible explanation could be that the mental health status of the participants at baseline was better than that during follow-ups, so it was very likely that participants paid more attention to coping with postoperative complications than mental health–related issues. Another reason might be that there was insufficient emphasis on the importance of mental health at the beginning of the program. Mental health is an important problem in patients with esophageal cancer, as many of these patients experience depressive symptoms and anxiety after surgery [
The CIMmH has yielded a unique opportunity to provide much needed postsurgical care in patients with esophageal cancer for the likely improvement of postoperative nutrition and the physical and mental status. This pilot study has shown that the CIMmH approach is a feasible and well-received option for ERAS in patients with esophageal cancer. Experiences of the CIMmH pilot study may help future development of a large randomized controlled trial or similar programs for patients with esophageal cancer or other cancers, especially those who are not able to visit the hospital frequently or who reside in rural areas. For example, patient adherence to the program needs to be enhanced in future interventions for better treatment effects, especially in the component of psychological intervention. More intervention programs should be delivered in video format, as video talks by medical doctors on patient self-care are particularly well received by patients.
Despite the positive outcomes, there were several limitations in this study. First, the sample size was small and there was no comparison group; thus, caution is needed to avoid over interpreting the findings. Second, some outcome data were missing owing to the drop-out of several patients at follow-up assessments. Third, effects of the CIMmH might be influenced by adherence and complications after surgery, which differ from patient to patient. Future studies should adopt a larger sample size and preferably use a randomized controlled trial design. The subjective experience of the participants should also be explored by collecting qualitative feedback throughout the study.
The CIMmH is the first mHealth-based comprehensive intervention developed and tested in patients with esophageal cancer after esophagectomy. Our results show that the CIMmH is usable, feasible, and safe among patients with esophageal cancer after surgery in China. Future studies with a more rigorous design and larger samples are needed to establish efficacy in patients with esophageal cancer and those with other types of cancers.
6-minute walk distance
comprehensive intervention model using the mobile health system
European Organization for Research and Treatment of Cancer-Quality of life Question-Core-30
European Organization for Research and Treatment of Cancer-Quality of life Question-Oesophageal Cancer Module-18
enhanced recovery after surgery
General Anxiety Disorder-7
mindfulness-based cancer recovery
mobile health
oral nutrition supply
partial enteral nutrition
Patient Health Questionnaire-9
postoperative day
Perceived Stress Scale-10
quality of life
total enteral nutrition
The authors would like to thank the patients, their family members, and the research staff at the hospital and research sites involved.
None declared.