Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening

NCT ID: NCT06069648

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-11

Study Completion Date

2026-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

factsheet about healthy living

Group Type PLACEBO_COMPARATOR

a leaftlet

Intervention Type BEHAVIORAL

a leaflet containing information about healthy lifestyles

printed decision aid

receive printed decision aid

Group Type EXPERIMENTAL

printed screening decision aid

Intervention Type BEHAVIORAL

a booklet form of screening decision aid containing information of cervical cancer screening options

mobile decision aid

receive mobile decision aid

Group Type EXPERIMENTAL

mobile screening decision aid

Intervention Type BEHAVIORAL

a mobile app format of screening decision aid containing information of cervical cancer screening options

Interventions

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printed screening decision aid

a booklet form of screening decision aid containing information of cervical cancer screening options

Intervention Type BEHAVIORAL

a leaftlet

a leaflet containing information about healthy lifestyles

Intervention Type BEHAVIORAL

mobile screening decision aid

a mobile app format of screening decision aid containing information of cervical cancer screening options

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dorothy Ngo Sheung Chan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Dorothy Chan

Role: CONTACT

+85239438165

Other Identifiers

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HMRFSADA

Identifier Type: -

Identifier Source: org_study_id

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