Condition category
Cancer
Date applied
04/05/2014
Date assigned
15/05/2014
Last edited
26/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Debin Wang

ORCID ID

Contact details

81 Meishan Road
Anhui Medical University
Hefei
230032
China

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 measures

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

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

Sponsor information

Organisation

Natural Science Foundation of China (China)

Sponsor details

83 Shuangqing Road
Haiding District
Beijing
Beijing
100000
China

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

National Natural Science Foundation of China

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26458906
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25886568

Publication citations

Additional files

Editorial Notes

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