Evidence map›Paper›PMID 38365704›Full record

ArticleTrials2024

Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol.

Ying Liang, Pengyu Jing, Zhongping Gu, Lei Shang, Peng Ge, Yong Zhang, Lv Wang, Chun Qiu, Ximing Zhu, Zhijun Tan

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Ying LiangDepartment of Health Statistics, Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, Airforce Military Medical University (Fourth Military Medical University), Xi'an, 710032, Shaanxi Province, China.
Pengyu JingDepartment of Thoracic Surgery, Tangdu Hospital, Xi'an, 710000, Shaanxi Province, China.
Zhongping GuDepartment of Thoracic Surgery, Tangdu Hospital, Xi'an, 710000, Shaanxi Province, China. gu-zhong-ping@163.com.
Lei ShangDepartment of Health Statistics, Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, Airforce Military Medical University (Fourth Military Medical University), Xi'an, 710032, Shaanxi Province, China. shanglei@fmmu.edu.cn.
Peng GeDepartment of Thoracic Surgery, The Second Affiliated Hospital of Xi'an Medical College, Xi'an, 710038, Shaanxi Province, China.
Yong ZhangDepartment of Thoracic Surgery, The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, XianYang, 712000, Shaanxi Province, China.
Lv WangDepartment of Thoracic Surgery, Daxing Hospital, Xi'an, 710000, Shaanxi Province, China.
Chun QiuDepartment of cerebral Surgery, Tangdu Hospital, Xi'an, Shaanxi Province, 710000, China.
Ximing ZhuDepartment of Thoracic Surgery, Tangdu Hospital, Xi'an, 710000, Shaanxi Province, China.
Zhijun TanDepartment of Health Statistics, Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, Airforce Military Medical University (Fourth Military Medical University), Xi'an, 710032, Shaanxi Province, China.
Tang Du Hospital · CNAir Force Medical University · CNAffiliated Hospital of Shaanxi University of Chinese Medicine · CNThe Second Affiliated Hospital of Xiamen Medical College

Funding

Tangdu Hospital discipline innovation development plan 2021LCYJ038Young Scientists Fund 82204151
6 · The paper itself

Abstract

introductionLung cancer is the most common cancer in China, with the highest mortality rate. Surgery is the primary treatment for early lung cancer. However, patients with lung cancer have a heavy burden of symptoms within 3 months after surgery, which seriously affects their quality of life (QOL). The symptom management model based on the patient-reported outcome (PRO) is considered the best caregiving model. The clinical evidence about the symptom management of lung cancer within 3 months after the operation is very limited. Herein, we propose a randomized controlled trial to evaluate the PRO score-based monitoring and alert system for follow-up on psychological and physiological symptoms of lung cancer patients within 3 months after surgery and further investigate the effect of intervention measures based on this PRO score-based system. METHODS AND ANALYSIS: This multicenter, open-label, randomized, parallel superiority trial will be conducted at four hospitals in China. A total of 440 lung cancer patients will be recruited in this study, who will be randomly assigned to the intervention group or the control group in a ratio of 1:1. Any of the target symptoms reaches the preset threshold (score ≥ 4), the patients will accept the symptom management advices based on the PRO. The patients in the control group will follow the current standard procedure of symptom management. The symptom management system is an electronic management system based on WeChat mini programs. All patients will be evaluated for symptoms through the lung cancer module of the MDASI lung cancer-specific scale on the day before surgery, days 1, 3, 5, and 7 after surgery, and once a week during the 12-week post-discharge period. Simultaneously, the EORTC QLQ-C30 scale will be used to evaluate patients' quality of life at baseline and the fourth and twelfth week after the surgery. The mean number of symptom threshold events of the intervention and the control groups were compared by t-test, and the changes of PRO were compared by a mixed effect model. The primary endpoint has been set as the 12-week post-discharge period. DISCUSSION: This study will test the feasibility of the symptom management system based on the mobile social media applet in postoperative caregiving and the efficacy of psychiatrist-assisted treatment and provide evidence in managing the symptoms of patients in the medium and long term. TRIALS REGISTRATION: Trials registration number: ChiCTR 2200058876, Registered 18 April 2022.

Indexed as

COVID-19Lung NeoplasmsAftercareEquivalence Trials as TopicHumansMulticenter Studies as TopicPatient DischargePatient Reported Outcome MeasuresQuality of LifeRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeLung cancerPatient-reported outcomeRandomized controlled trialSymptom management

Identifiers

PMID38365704
PMCPMC10874066
OpenAlexW4391898644

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.