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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Cervical Cancer

Treatments: Behavioral: a leaftlet; Behavioral: mobile screening decision aid; Behavioral: printed screening decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT06069648

HMRFSADA

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: Female

Ages: 25 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 3 patient groups, including a placebo group

control

Placebo Comparator group

Description:

factsheet about healthy living

Treatment:

Behavioral: a leaftlet

printed decision aid

Experimental group

Description:

receive printed decision aid

Treatment:

Behavioral: printed screening decision aid

mobile decision aid

Experimental group

Description:

receive mobile decision aid

Treatment:

Behavioral: mobile screening decision aid