Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
eCROPS-CA: a systematic approach toward effective and sustainable cancer prevention in rural China
Acronym
eCROPS-CA
Study hypothesis
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
Anhui Medical University Biomedical Ethics Committee, 01/03/2014, ref. 20140271
Study design
Quasi cluster randomized controlled trial using equal intervention and delayed intervention arms
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Diagnosis of nine common cancers surveyed every 6 months after project initiation.
Secondary outcome measures
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.
Overall trial start date
01/05/2014
Overall trial end date
30/04/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4320
Participant exclusion criteria
Villagers who have already diagnosed with cancer and mental illness or serious illness or disability are excluded.
Recruitment start date
01/05/2014
Recruitment end date
30/04/2019
Locations
Countries of recruitment
China
Trial participating centre
Anhui Medical University
Hefei
230032
China
Funders
Funder type
Research organisation
Funder name
National Natural Science Foundation of China
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, NSFC, NNSF, NNSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Funder name
Anhui Medical University - Center for Cancer Control Collaboration (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26458906
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25886568