Effectiveness of Decision-aid Video on Colorectal Cancer Screening

NCT04692987 | Unknown DMC

• 1 other identifier: FF-2020-155
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is the second most common cancer in Malaysia. Diagnosing CRC at early stage is crucial to reduce their mortality risk. To achieve this aim, CRC screening promotion intervention is deemed necessary.

Conditions

Colorectal Cancer

Keywords

Screening; Primary care; Video

Outcome Measures

Primary Outcomes (1)

• Number of participants with colorectal cancer screening completion

  Number of participants with completion of fecal occult blood test or colonoscopy procedures by participants

  3 months

Secondary Outcomes (3)

• Number of participants with colonoscopy completion among those with positive fecal occult blood test

  3 months

• Period time from intervention to fecal occult blood test uptake

  3 months

• Barriers towards the colorectal cancer screening uptake

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive decision-aid video

Other: Decision-aid video

Usual care

NO INTERVENTION

Participants will receive usual care

Interventions

Decision-aid video OTHER

Decision-aid video will be developed to disseminate knowledge and to raise awareness on colorectal cancer screening

Intervention

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malaysian aged 50 - 74 years old
• No previous history or family history of CRC
• Asymptomatic of CRC
• Never participated in CRC screening

You may not qualify if:

• Acute patients
• Patients on aspirin, warfarin or any blood-thinning agent
• Illiterate or having a significant vision or hearing impairment

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

The National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Azmawati Mohammed Nawi

  The National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azmawati Mohammed Nawi, Medical

CONTACT

+6 03 8921 5555340; azmawati@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Investigators will designate participants to which arm using random sampling. Participants and care providers are masked to which arm they receive.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Specialist & Medical Lecturer

Model Details: Parallel randomized controlled trial will be conducted in 3 months duration, with intention-to-treat.

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 5, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)