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

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer
• Interventions: Behavioral: a leaftlet; Behavioral: printed screening decision aid; Behavioral: mobile screening decision aid

• Registration Number: NCT06069648
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Study Start: 2024-07-11
• Primary Completion: 2026-03-10
• Study Completion: 2026-03-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 270

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.

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Exclusion Criteria

• NA

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	a leaftlet	factsheet about healthy living
printed decision aid	printed screening decision aid	receive printed decision aid
mobile decision aid	mobile screening decision aid	receive mobile decision aid

Primary Outcome Measures

Name	Time	Method
cervical cancer screening uptake	3 months after intervention	The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?
decisional conflict	baseline and 2 weeks after intervention	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.

Secondary Outcome Measures

Name	Time	Method
screening decision: choice predisposition	baseline and 2 weeks after intervention	Choice predisposition assesses a person's leaning towards an option and is rated on a 15-point scale that ranges from 1 (leaning towards 'yes') to 15 (leaning towards 'no').
screening decision: choice question	baseline and 2 weeks after intervention	The choice question asks about the screening decision and a question about the use of a screening option (Pap test/HPV testing). It is assessed using a 'no/yes/unsure' format.
risk perception	baseline and 2 weeks after intervention	One question will be used to assess the participants' perceptions of their risk of cancer. Women will be asked to rate their risk of cervical cancer as low, moderate or high.