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 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
81 Meishan Road
Anhui Medical University
Hefei
230032
China
Study information
| Study design | Quasi cluster randomized controlled trial using equal intervention and delayed intervention arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/05/2014 |
| Completion date | 30/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
230032
China
Sponsor information
Research organisation
83 Shuangqing Road
Haiding District
Beijing
Beijing
100000
China
"ROR" |
https://ror.org/01h0zpd94 |
|---|
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
26/01/2016: Publication reference added.
16/10/2015: Publication reference added.
