Prevention of cancers using eCROPS-CA (electronic supports and supervision, Counseling behavior prevention, Recipe for objective behaviors, Operational toolkit, Performance-based incentives for doctors, and Screening and assessment)

ISRCTN	ISRCTN33269053
DOI	https://doi.org/10.1186/ISRCTN33269053
Protocol serial number	N/A
Sponsor	Natural Science Foundation of China (China)
Funders	National Natural Science Foundation of China, Anhui Medical University - Center for Cancer Control Collaboration (China)

Submission date: 04/05/2014
Registration date: 15/05/2014
Last edited: 26/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Effective cancer prevention depends on a sustained individual effort to practice protective behaviors and avoid risk factors, which requires personalized support. However, current prevention mainly relies on strategies targeting the general population or, at most, selected specific groups, with limited attention being paid to individualized approaches. This aim of this study is to test a new behavior intervention package called eCROPS-CA.

Who can participate?
Men and women at high risk of cancer who are over 35 years old and living in one of the 36 administrative villages randomly sampled from nine counties in Anhui province, China.

What does the study involve?
Participants are randomly allocated into either the intervention group or the delayed intervention group. The intervention group receives the eCROPS-CA behavior intervention package for 5 years and will undergo a baseline evaluation at the start of the study and 10 semi-annual follow-up evaluations. The delayed intervention group does not receive eCROPS-CA but will undergo the baseline and follow-up evaluations.

What are the possible benefits and risks of participating?
The anticipated benefits are improved knowledge about cancers, prevention, and health services from the village doctors, improved lifestyle, and early diagnosis of cancer and cancer-related conditions. Potential risks and discomforts include potential loss of privacy if diagnosed with cancers or cancer-related conditions, and the time taken for the assessment and follow-up (about 1 hour each).

Where is the study run from?
36 village clinics in Anhui province, China will take part in the study and their names are determined at random.

When is the study starting and how long is it expected to run for?
The study will run from May 2014 to April 2019.

Who is funding the study?
Natural Science Foundation of China and Center for Cancer Control Collaboration of Anhui Medical University (China).

Who is the main contact?
Dr Jing Chai
jingchai82@sina.com

Contact information

Prof Debin Wang
Scientific

81 Meishan Road
Anhui Medical University
Hefei
230032
China

Study information

Primary study design	Interventional
Study design	Quasi cluster randomized controlled trial using equal intervention and delayed intervention arms
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	eCROPS-CA: a systematic approach toward effective and sustainable cancer prevention in rural China
Study acronym	eCROPS-CA
Study objectives	This project aims at demonstrating that eCROPS-CA is effective in preventing cancers, and high-risk individuals in the intervention arm will, compared to those in the control condition, show a lower incidence of cancers, improved biophysical indicators, increased service use and involvement in protective behaviors. A secondary objective is to establish a sustainable mechanism, in which participating village doctors maintain continuous momentum integrating cancer prevention with routine medical service ever since initiation of this project in resource-poor rural China.
Ethics approval(s)	Anhui Medical University Biomedical Ethics Committee, 01/03/2014, ref. 20140271
Health condition(s) or problem(s) studied	Nine common cancers (trachea/bronchus/lung cancer, stomach cancer, colon/rectum/anus cancer, liver cancer, esophagus cancer, breast cancer, pancreas cancer, lymphoma cancer, and bladder cancer)
Intervention	The study recruits 36 administrative villages from nine counties in Anhui province, China and assigns them into equal intervention and delayed intervention arms. The intervention arm receives baseline and 10 semi-annual follow-up evaluations plus 5 years of eCROPS-CA. The delayed intervention arm receives only the baseline and follow-up evaluations.
Intervention type	Other
Primary outcome measure(s)	Diagnosis of nine common cancers surveyed every 6 months after project initiation.
Key secondary outcome measure(s)	1. Cancer-related knowledge, attitudes and practices 2. Cancer-related biophysical indicators, e.g., hypertension, gastritis, pre-diabetes/diabetes 3. Intervention compliance Secondary outcome measure(s) will be measured using structured questionnaires (for objective behaviors and service use), scales (for body weight and height), sphygmomanometer (for blood pressure) and tests (for blood glucose and other easy biological indicators) at baseline and every 6 months after baseline for 5 years.
Completion date	30/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	4320
Key inclusion criteria	Men and women who: 1. Are over 35 years old 2. Llive in the selected villages for over 6 months per year 3. Meet rapid risk assessment score (≥70) and detailed risk assessment score (≥80) threshold
Key exclusion criteria	Villagers who have already diagnosed with cancer and mental illness or serious illness or disability are excluded.
Date of first enrolment	01/05/2014
Date of final enrolment	30/04/2019

Locations

Countries of recruitment

China

Study participating centre

Anhui Medical University

Hefei
230032
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/04/2015		Yes	No
Results article	results	12/10/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/01/2016: Publication reference added.
16/10/2015: Publication reference added.