Colorectal Cancer Screening, Patient Navigation
Conditions
Keywords
RCT, colorectal cancer screening, patient navigation, Malaysia, depression, anxiety, HADS, GHQ12
Brief summary
The goal of this randomized controlled trial is to evaluate the effectiveness of patient navigation on colonoscopy completion rates in a population screened for colorectal cancer. The main question\[s\] it aims to answer are: Are colonoscopy completion rates in colorectal cancer screening increased in navigated (intervention arm) compared with non-navigated (control arm) participants? Is mental well-being, as measured by HADs and GHQ12 scores, better in the intervention arm compared with the control arm? Participants in the intervention arm will receive: * standard clinic instructions for the colonoscopy * phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure * a webpage QR code consist of information on visual image on colonoscopy preparation and procedures, layout and map guidance to navigate in the hospital * a direct line for phone calls to patient navigators for further guidance on overcoming barriers Participants in the control arm will only receive: * standard clinic instructions for the colonoscopy * one phone call from the patient navigator to discuss the colonoscopy procedure
Interventions
BEHAVIORALPatient navigation
Participants will receive online educational material, hospital site navigation guidance and direct contact with the patient navigator, in addition to standard instructions on the colonoscopy procedure.
Sponsors
Ministry of Health, Malaysia
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Average risk for CRC * More than 50 years of age * Capacity for informed consent * IFOBT positive
Exclusion criteria
* Moderate or high risk CRC * Previous CRC screening * Symptomatic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonoscopy completion rate | 90 days | The numerator in both arms comprises participants who successfully attended and underwent colonoscopy within 90 days of recruitment. The denominator in both arms comprises all participants randomized to that arm. Colonoscopy completion rate was defined as the percentage of participants who completed colonoscopy within 90 days of randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mental health - anxiety and depression | 90 days | The mental health of participants in both arms was assessed pre- and post-colonoscopy using the Hospital Anxiety & Depression Scale (HADS). The score may range from 0-21. Scores of 0-7 are normal, 8-10 is mild, 11-14 is moderate and 15-21 is severe anxiety or depression. |
| Mental health - General psychological distress | 90 days | The mental health of participants in both arms was assessed pre- and post-colonoscopy using the General Health Questionnaire 12 (GHQ12) tool as a measure of general psychological distress. Each item in the 12-item questionnaire was scored on a Likert scale of 0-3, for a total score ranging from 0-36. High scores indicate worse health. |
Countries
Malaysia
Outcome results
None listed