Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544852
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2019-09-05
Brief Title:
Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer
Sponsor:
National University Health System Singapore
Organization:
National University Health System Singapore
Study Overview
Official Title:
Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer Through a Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2023-06
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:
To determine amongst spouses of colorectal cancer patients
1 Screening rates for Colorectal Cancer CRC amongst spouses of patients with CRC
2 Barriers to screening based on the Health Belief Model HBM
3 Mediators to behaviour change using the transtheoretical model of behavioural change
4 If tailored interventions addressing education convenience and cost would improve screening rates amongst the spouses
1 Screening rates for Colorectal Cancer CRC amongst spouses of patients with CRC
2 Barriers to screening based on the Health Belief Model HBM
3 Mediators to behaviour change using the transtheoretical model of behavioural change
4 If tailored interventions addressing education convenience and cost would improve screening rates amongst the spouses
Detailed Description:
Stage 1 Randomization into Intervention versus Control
The eligible participants will be randomized into either Intervention or Control after the study team obtains participants informed consent and before they begin doing the questionnaires A randomisation list is generated using a computer procedure using block randomization Based on the randomisation list the assigned groups for each study participants ID are written in a sealed opaque envelope The envelope will be open at the point of randomisation to find out which group participant is randomised to
The Intervention arm is aimed at specifically addressing gaps in terms of knowledge of colorectal cancer and the importance of screening as well as targeting cost as well as convenience issues Spouses who have been randomized into this arm will undergo a session with a trained research assistant who will highlight the following points
1 What is colorectal cancer and what are its risk factors
2 What is the spouse possibly at risk of developing colorectal cancer
3 How can screening help to reduce the risk of colorectal cancer
4 What are the screening modalities for CRC
5 What are FIT kits
6 How to use FIT kits
7 Where to return the FIT kits once they have been used
All participants who have undergone the counseling session will then be given 2 x FIT kits as recommended in the guidelines free of charge and also advised to mail the FIT kits back to the colorectal clinic in a pre-paid envelope once it has been used By performing the above targeted interventions we would have tackled issues relating to education cost and convenience
The Control arm is the current practice in the community where these participants would be informed that the FIT kits can be obtained from the Singapore Cancer Society SCS free of charge if they fulfil the screening criteria as stipulated in the MOH guidelines The participants will be advised on the various locations to collect these FIT kits
The endpoint for the intervention and the control arms is whether the spouses returned the FIT kits within 3 months from date of consent
Stage 2 Questionnaires
After obtaining informed consent the spouse would be asked to fill in the baseline demographic form After that they will be asked if they have undergone any prior screening as recommended by the MOH screening guidelines as stipulated earlier Following that a quantitative questionnaire utilizing the validated Health Belief Model would be administered to study the potential barriers to screening which may be faced by the spouses This questionnaire is based on the 5 domains of the Health Belief Model which include perceived susceptibility to acquiring CRC perceived severity of the disease perceived benefit of going for screening perceived barriers to action and cues to action The response options for questions on these domains are categorized into disagree agree and unsure
A second questionnaire based on the transtheoretical model would then be implemented next We would determine their stage in the transtheoretical model based on their responses The basic questionnaire was based on previous published data This questionnaire will take approximately 5 minutes to complete
Faecal Occult Blood Test or Colonoscopy
Never heard Has not heard of FOBT or colonoscopy Precontemplation Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago and not thinking about having an FOBT or colonoscopy in the next 2 months
Contemplation Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago but thinking about having an FOBT or colonoscopy in the next 2 months
Action FOBT was within the last year or colonoscopy was within the last year Maintenance Has undergone two or more FOBTs in the past 2 years or has undergone at least two or more colonoscopies and would continue to do so in concordance with the schedule
The same questionnaire would be repeated in 3 months and 6-12 months following the initial interview with at least 3 months between each follow-up This is in sync with the appointments that the patients themselves would be attending as part of their surveillance for their CRC This is to document the changes in their responses to the various domains as the impact of the patients cancers is less felt with time The responses would guide the research team to determine if the peri-operative period remains the best time to advise the spouses to undergo screening or if we should delay it to a more appropriate and hence receptive period
The eligible participants will be randomized into either Intervention or Control after the study team obtains participants informed consent and before they begin doing the questionnaires A randomisation list is generated using a computer procedure using block randomization Based on the randomisation list the assigned groups for each study participants ID are written in a sealed opaque envelope The envelope will be open at the point of randomisation to find out which group participant is randomised to
The Intervention arm is aimed at specifically addressing gaps in terms of knowledge of colorectal cancer and the importance of screening as well as targeting cost as well as convenience issues Spouses who have been randomized into this arm will undergo a session with a trained research assistant who will highlight the following points
1 What is colorectal cancer and what are its risk factors
2 What is the spouse possibly at risk of developing colorectal cancer
3 How can screening help to reduce the risk of colorectal cancer
4 What are the screening modalities for CRC
5 What are FIT kits
6 How to use FIT kits
7 Where to return the FIT kits once they have been used
All participants who have undergone the counseling session will then be given 2 x FIT kits as recommended in the guidelines free of charge and also advised to mail the FIT kits back to the colorectal clinic in a pre-paid envelope once it has been used By performing the above targeted interventions we would have tackled issues relating to education cost and convenience
The Control arm is the current practice in the community where these participants would be informed that the FIT kits can be obtained from the Singapore Cancer Society SCS free of charge if they fulfil the screening criteria as stipulated in the MOH guidelines The participants will be advised on the various locations to collect these FIT kits
The endpoint for the intervention and the control arms is whether the spouses returned the FIT kits within 3 months from date of consent
Stage 2 Questionnaires
After obtaining informed consent the spouse would be asked to fill in the baseline demographic form After that they will be asked if they have undergone any prior screening as recommended by the MOH screening guidelines as stipulated earlier Following that a quantitative questionnaire utilizing the validated Health Belief Model would be administered to study the potential barriers to screening which may be faced by the spouses This questionnaire is based on the 5 domains of the Health Belief Model which include perceived susceptibility to acquiring CRC perceived severity of the disease perceived benefit of going for screening perceived barriers to action and cues to action The response options for questions on these domains are categorized into disagree agree and unsure
A second questionnaire based on the transtheoretical model would then be implemented next We would determine their stage in the transtheoretical model based on their responses The basic questionnaire was based on previous published data This questionnaire will take approximately 5 minutes to complete
Faecal Occult Blood Test or Colonoscopy
Never heard Has not heard of FOBT or colonoscopy Precontemplation Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago and not thinking about having an FOBT or colonoscopy in the next 2 months
Contemplation Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago but thinking about having an FOBT or colonoscopy in the next 2 months
Action FOBT was within the last year or colonoscopy was within the last year Maintenance Has undergone two or more FOBTs in the past 2 years or has undergone at least two or more colonoscopies and would continue to do so in concordance with the schedule
The same questionnaire would be repeated in 3 months and 6-12 months following the initial interview with at least 3 months between each follow-up This is in sync with the appointments that the patients themselves would be attending as part of their surveillance for their CRC This is to document the changes in their responses to the various domains as the impact of the patients cancers is less felt with time The responses would guide the research team to determine if the peri-operative period remains the best time to advise the spouses to undergo screening or if we should delay it to a more appropriate and hence receptive period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None