Condition category
Cancer
Date applied
22/06/2017
Date assigned
27/06/2017
Last edited
26/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Lung cancer is one of the most common cancers worldwide. Routine inpatient care (RIC) for lung cancer consists of a combination of procedures. Each of these procedures not only affects disease outcomes but also incur considerable costs. Due to free selection of hospitals and lack of referral and follow-up mechanisms in China, physicians at individual hospitals cannot link their routine diagnosis and treatment with patients’ mid- and long-term outcomes. This study examines RIC for lung cancer patients and explores paths of combinations of RIC procedures and their contributions to patient outcomes taking costs into consideration.

Who can participate?
Patients aged 18 and over with lung cancer, from rural Anhui province, China

What does the study involve?
The participants’ medical records from all their inpatient care at different hospitals due to cancer are retrieved. The RIC procedures and their costs are extracted from the records and patient outcomes (e.g., survival time, quality of life) are collected through a follow-up survey.

What are the possible benefits and risks of participating?
The results of this study will help to improve treatment by improving outcomes and/or lowering costs.

Where is the study run from?
Anhui Medical University (China)

When is the study starting and how long is it expected to run for?
July 2017 to June 2019

Who is funding the study?
Anhui Provincial Government (China)

Who is the main contact?
Miss Xingrong Shen
xinrongshen@sina.com

Trial website

Contact information

Type

Public

Primary contact

Miss Xinrong Shen

ORCID ID

Contact details

81 Meishan Road
Hefei
230032
China
+86 (0)551 5116395
xinrongshen@sina.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cost-effectiveness evaluation of routine inpatient care for lung cancer patients in rural Anhui, China: methods and measures

Acronym

Study hypothesis

There is a general paucity of and an urgent need for data on the cost-effectiveness of complex combinations of routine inpatient care (RIC) procedures for cancer patients which not only affect disease outcomes but also incur considerable costs. This study examines RIC for lung cancer patients in rural Anhui, China and explores paths of combinations of RIC procedures and their contributions to patient outcomes taking costs into consideration.

Ethics approval

Anhui Medical University Biomedical Ethics Committee, 23/03/2017, ref: 20170311

Study design

Retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Lung cancer

Intervention

The study adopts a retrospective cohort study design and proceeds in 5 steps. Step 1 defines 4 main categories of study variables including clinical procedures, direct cost and effectiveness of the procedures, and factors affecting use of the procedures and their cost and effectiveness. Step 2 selects a cohort of 5000 lung cancer patients diagnosed between 01/07/2014 and 30/06/2015 from rural Anhui by clustered randomization. Step 3 retrieves the records of all the inpatient care episodes incurred by the cohort for treating their lung cancer and extracts data about RIC procedures, immediate patient outcomes (e.g., Karnofsky performance status, symptom score, lung function score) and influencing factors (e.g., stage of cancer, age, gender) by two independent researchers using a pre-developed worksheet. Step 4 estimates the direct cost of each of the RIC procedures identified using micro-costing and collects data about long-term patient outcomes (e.g., progression-free survival, quality of life) through a follow-up survey of patients or their relatives. Step 5 analyzes data collected and explores paths of RIC procedures and their relations with patient outcomes, costs and a whole range of clinical and socio-demographic factors using frequency-cost tabulation, procedure-outcome trees, multivariate regression models and others.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Gains in months of survival per unit cost
2. Gains in months of progression-free survival per unit cost
Measured at endpoint of the study, i.e., some 2 to 2.5 years after first diagnosis of lung cancer

Secondary outcome measures

1. Gains in quality of life score per unit cost
2. Gains in Karnofsky Performance status (KPS) per unit cost
3. Per unit cost gains in compiled indices of symptoms (e.g., chronic cough, chest pain, dysphonia, wasting syndrome, fever)
4. Lung functions (e.g., forced vital capacity, forced expiratory volume in one second, TLCO-SB)
5. Imaging findings (e.g., number of nodes identified in the lung, maximum size of the nodes, presence of abnormalities with the mediastinum or hilum, presence of pleura or pericardial effusion)
6. Biological test findings (e.g., value of CEA, CA125, proGRP, SCC, NSE)
7. Complications and comorbidities (e.g., presence of superior vena cava syndrome, superior vena cava syndrome, cerebral thrombosis or cerebral hemorrhage, chronic fibrous pneumonia, pulmonary embolism, cardiac insufficiency, arrhythmi)
Measured at each episode of hospitalization, i.e., at 4 to 6 time points after the first diagnosis of lung cancer depending on actual times of hospitalization due to the lung cancer by individual patients

Overall trial start date

01/07/2017

Overall trial end date

30/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Lung cancer patients diagnosed between 01/07/2014 and 30/06/2015 from rural Anhui
2. Aged 18 or older

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

5000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

China

Trial participating centre

Anhui Medical University
Meishan Road 81
Hefei
230000
China

Sponsor information

Organisation

Anhui Medical University

Sponsor details

81 Meishan Road
Hefei
230032
China

Sponsor type

University/education

Website

http://www.ahmu.edu.cn

Funders

Funder type

Government

Funder name

Anhui Provincial Government

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal(s) between 2018 and 2019.

IPD sharing statement
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Intention to publish date

31/12/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes