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Trial Title:
Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening
NCT ID:
NCT06069648
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
screening
South Asians
ethnic minority
decision aid
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
printed screening decision aid
Description:
a booklet form of screening decision aid containing information of cervical cancer
screening options
Arm group label:
printed decision aid
Intervention type:
Behavioral
Intervention name:
a leaftlet
Description:
a leaflet containing information about healthy lifestyles
Arm group label:
control
Intervention type:
Behavioral
Intervention name:
mobile screening decision aid
Description:
a mobile app format of screening decision aid containing information of cervical cancer
screening options
Arm group label:
mobile decision aid
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Indian, Pakistani or Nepalese;
2. aged 25 to 64;
3. no history of cervical cancer or total hysterectomy;
4. have a history of sexual activity;
5. cannot understand Chinese but can read or communicate in English, Hindi, Urdu or
Nepali;
6. have not had a Pap/HPV test in the past 3 years;
7. have and are willing to use a smartphone in this intervention.
Exclusion Criteria:
- NA
Gender:
Female
Gender based:
Yes
Minimum age:
25 Years
Maximum age:
64 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
July 11, 2024
Completion date:
March 10, 2026
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06069648
