Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188305
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2005-09-09
Brief Title:
A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Having at least one first-degree relative FDR with colon cancer increases an individuals risk of developing the disease Many relatives of cancer patients are ineligible for genetic testing and therefore do not receive information from a healthcare provider about the disease Providing relatives of cancer patients with information about their risk of developing colon cancer screening information and other colon-related health information may increase knowledge and screening compliance as has been shown in relatives of breast cancer patients The primary aim of this study is to test the efficacy of two modes in-person vs telephone of providing a risk counseling and health promotion intervention for relatives of cancer patients on measures of knowledge of colon cancer risk and health-related factors comprehension of risk understanding of screening recommendations and intent to adopt an appropriate screening regimen Participants will be randomized into one of three study arms in-person telephone control An assessment pre- and post- intervention will be conducted In addition longer-term follow-ups will be carried out two months and one year following the intervention to examine the sustainability of the intervention effect
Detailed Description:
Colorectal cancer CRC is the second leading cause of cancer death in North America despite being referred to as preventable and curable if detected early Early detection through preventive screening has been found to decrease CRC death However adherence to CRC screening is poor both in average risk and higher risk individuals Lack of knowledge of CRC risk and screening recommendations and psychological factors such as perceived risk of CRC have been cited as important factors associated with screening compliance By increasing knowledge and appropriate risk comprehension it is possible to increase lifelong long-term screening adherence rather than one-time compliance This is especially important because CRC screening can be unpleasant and if individuals are not clear of their risk and other important information about CRC they may be reluctant to continue with a screening program Having at least one first-degree relative FDR with CRC increases an individuals risk of developing the disease Many relatives of CRC probands are ineligible for genetic testing and therefore do not receive information from a healthcare provider about the disease Providing relatives of CRC probands with information about their risk of developing CRC screening information and other CRC-related health information may increase knowledge and screening compliance as has been shown in relatives of breast cancer patients Previous educational interventions with relatives of breast cancer probands have demonstrated increased knowledge screening behaviour risk comprehension and decreased distress While these interventions have been effective with relatives of breast cancer patients these interventions have not been conducted to date with relatives of CRC patients We believe that relatives of CRC patients could also benefit from this type of educational session Educational interventions with relatives of breasts cancer patients have been conducted in-person however in clinical genetic counseling sessions are conducted both in-person and by telephone Telephone counseling has become widespread in clinical services despite a lack of evidence to support its effectiveness compared to in-person counseling Preliminary studies have shown that telephone interventions increase participation in screening programs but few studies have directly compared telephone and in-person counseling The primary aim of this study is to test the efficacy of two modes in-person vs telephone of providing a risk counseling and health promotion intervention for relatives of CRC probands on measures of knowledge of CRC risk and health-related factors comprehension of risk understanding of screening recommendations and intent to adopt an appropriate screening regimen Participants will be randomized into one of three study arms in-person telephone control An assessment pre- and post- intervention will be conducted In addition longer-term follow-ups will be carried out two months and one year following the intervention to examine the sustainability of the intervention effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None