This randomized controlled trial aims to measure the effectiveness of a counseling-based intervention in motivating index cases (counselees) in sharing cancer risk information with their first-degree relatives (FDRs), and whether the trail is effective in initiating/increasing the uptake of screening in FDRs of index patients who are registered in cancer registry system. Sample size includes 120 FDRs in intervention group, and 120 FDRs in control group. Intervention includes an in-person motivational counseling session with FDRs performed by psychosocial workers, plus consequent follow-up reminder calls. Motivational interview comprises individualized and interactive counseling which addresses risk assessment, screening barriers, and provides appropriate feedbacks to the counselees. Free colonoscopy and polypectomy will be offered to the both groups of study as well as adequate education on bowel prep and colonoscopy procedure for those who are willing to perform colonoscopy. Measures will be recorded at the baseline and maximum 6 months after the baseline. Primary outcome is performing colonoscopy in FDRs. Secondary outcome measures include FDRs’ awareness, and knowledge on cancer, and their screening practice, barriers of screening.
General information
Acronym
Triple C (Colon Cancer Control) Trail
IRCT registration information
IRCT registration number:IRCT2015061422711N1
Registration date:2015-09-04, 1394/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Hamideh Salimzadeh
Name of organization / entity
Digestive Diseases Research Institute,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5492
Email address
hsalimzadeh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2016-07-01, 1395/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Risk assessment counseling and screening in first degree relatives of colon cancer patients
Public title
Colon cancer screening in high-risk population
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: Male and female siblings, parents, and children, of colon cancer patients who were 60 yrs. or younger at the time of cancer diagnosis.
Exclusion criteria: Performing total colonoscopy with in last year; personal history of colon cancer; personal history of irritable bowel diseases; age 76 and older
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
the Institutional Review Boards of Tehran University of Medical Sciences, and Digestive Diseases Re
Street address
Digestive Diseases Research Institute, Shariati Hospital, Tehran University of Medical Sciencesو North Kargar Avenue 14666 Tehran, Iran
City
Tehran
Postal code
1411713135
Approval date
2013-02-03, 1391/11/15
Ethics committee reference number
301/481
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C18, C19,
ICD-10 code description
Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum
Primary outcomes
1
Description
Screening Colonoscopy
Timepoint
0, 6months follow-up
Method of measurement
Colonoscopy report verification
Secondary outcomes
1
Description
knowledge, and awareness about colon cancer
Timepoint
0; 6 month follow-up
Method of measurement
Interview
2
Description
knowledge, and awareness on screening tests of colon cancer
Timepoint
0; 6 month follow-up
Method of measurement
Interview
Intervention groups
1
Description
Intervention includes below:
• Tailored massages via phone counseling
• Interactive and in-person counseling about screening barriers
• Individualized motivational interview
• Consequent Follow-up reminder calls
Category
Early detection
2
Description
One parallel control group of usual care will be designed in this study. That is, counselees (index patients or FDRs) in control group will receive a simple doctor recommendation that screening is necessary should be done in FDRs, and that they better to inform their FDRs, as happened in routine care, the main source of recommendation is doctor’s recommendation. Usually index patients during their treatment are informed by doctors about the risk of developing cancer in their relatives and the significance of screening or early detection among their relatives.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Digestive Diseases Research Institute
Full name of responsible person
Dr. Hamideh Salimzadeh
Street address
Digestive Diseases Research Institute,Tehran University of Medical Sciences, Shariati Hospital, North Kargar Avenue, 14666, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Delavari
Street address
Shariati Hospital, North Kargar Avenue 14666 Tehran, Iran.
City
Tehran
Grant name
طرح پژوهشی
Grant code / Reference number
301/481
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Digestive Diseases Research Institute,Tehran University of Medical Sciences,
Full name of responsible person
Dr Hamideh Salimzadeh
Position
Phd in Health Education/Assisstant Proffesor
Other areas of specialty/work
Street address
Digestive Diseases Research Institute,Tehran University of Medical Sciences, Shariati Hospital, North Kargar Avenue, 14666, Tehran, Iran
City
Tehran
Postal code
1411713135
Phone
+98 21 8241 5492
Fax
+98 21 8241 5400
Email
salimzadeh.h@gmail.com
Web page address
www.ddri.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Digestive Diseases Research Institute
Full name of responsible person
Dr. Hamideh Salimzadeh
Position
PhD in Health Educationt/Assistant professor
Other areas of specialty/work
Street address
Digestive Diseases Research Institute,Tehran University of Medical Sciences, Shariati Hospital, North Kargar Avenue, 14666, Tehran, Iran
City
Tehran
Postal code
1411813135
Phone
+98 21 8241 5492
Fax
+98 82415400
Email
salimzadeh.h@gmail.com
Web page address
www.ddri.ir
Person responsible for updating data
Contact
Name of organization / entity
Digestive Diseases Research Institute
Full name of responsible person
Dr. Hamideh Salimzadeh
Position
PhِD in Health education/Assistant professor
Other areas of specialty/work
Street address
Digestive Diseases Research Institute,Tehran University of Medical Sciences, Shariati Hospital, North Kargar Avenue, 14666, Tehran, Iran
City
Tehran
Postal code
1411713135
Phone
+98 21 8241 5492
Fax
+98 21 8241 5400
Email
salimzadeh.h@gmail.com
Web page address
www.ddri.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)