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| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
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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:
Participants in the control arm will only receive:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient navigation | Experimental | Participants in the intervention arm will undergo a patient navigation process |
|
| No navigation | No Intervention | Participants in the control arm will receive standard instructions and not undergo the patient navigation process. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient navigation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopy completion rate | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mental health - anxiety and depression | 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. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| April C Roslani, Master of Surgery | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Universiti Malaya | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
Informed consent was only given for the purposes of this study.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Mental health - General psychological distress |
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. |
| 90 days |
| D006298 | Health Services Administration |