Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening
1 other identifier
interventional
270
0 countries
N/A
Brief Summary
Objectives: To examine the effects of linguistically appropriate decision aids on decisional conflicts, risk perception, clarity of values, screening decisions and screening uptake among South Asian women in Hong Kong Design and subjects: A randomised controlled trial. A sample of 270 South Asian women aged 25-64 will be recruited to one of the two intervention groups or control group. Instruments: A survey will be conducted to collect data on the variables of concern (decisional conflicts, risk perception, clarity of values, screening decision and screening uptake). Interventions: Ethnically match community health workers (CHWs) will deliver the printed or mobile application decision aids to intervention group participants and briefly explain how to use the decision aid. The participants will choose a time and place of their convenience to read the decision aid. The participants will be contacted by CHWs within 2 weeks and asked if they have experienced any problems. Navigation assistance will be given as requested. Main outcome measures: Decisional conflicts, risk perception, clarity of values, screening decision and uptake. Data analysis: The repeated-measure outcomes of risk perception, clarity of values, decisional conflicts and screening decision will be compared between the three groups while adjusting for the stratifying variable (ethnicity) using a generalised estimating equation model, and a multivariable logistic regression with adjustment for ethnicity will be used to compare the screening uptake of the three groups. Expected results: The decision aid will clarify the participants' values and help them to make screening decisions and increase the uptake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedStudy Start
First participant enrolled
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2026
CompletedFebruary 7, 2024
February 1, 2024
1.7 years
September 22, 2023
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
decisional conflict
16-item Decisional Conflict Scale will be used to measure decisional conflict. The scale consists of five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale and effective decision subscale. The scores will be converted to a 0-100 scale, giving a possible range of 0 (no decisional conflict) to 100 (extremely high decisional conflict). A score of 25 or below indicates that a person has low decisional conflict, and a score of 37.5 and above indicates that a person has decisional delay.
baseline and 2 weeks after intervention
cervical cancer screening uptake
The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?
3 months after intervention
Secondary Outcomes (3)
risk perception
baseline and 2 weeks after intervention
screening decision: choice predisposition
baseline and 2 weeks after intervention
screening decision: choice question
baseline and 2 weeks after intervention
Study Arms (3)
control
PLACEBO COMPARATORfactsheet about healthy living
printed decision aid
EXPERIMENTALreceive printed decision aid
mobile decision aid
EXPERIMENTALreceive mobile decision aid
Interventions
a booklet form of screening decision aid containing information of cervical cancer screening options
a mobile app format of screening decision aid containing information of cervical cancer screening options
Eligibility Criteria
You may qualify if:
- Indian, Pakistani or Nepalese;
- aged 25 to 64;
- no history of cervical cancer or total hysterectomy;
- have a history of sexual activity;
- cannot understand Chinese but can read or communicate in English, Hindi, Urdu or Nepali;
- have not had a Pap/HPV test in the past 3 years;
- have and are willing to use a smartphone in this intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 22, 2023
First Posted
October 6, 2023
Study Start
July 11, 2024
Primary Completion
March 10, 2026
Study Completion
March 10, 2026
Last Updated
February 7, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share