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

Study Overview
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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.

Official Title
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Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening: A Randomised Controlled Trial

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: printed screening decision aid
* Behavioral: a leaftlet
* Behavioral: mobile screening decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>factsheet about healthy living | Behavioral: a leaftlet<br>* a leaflet containing information about healthy lifestyles<br>|
| Experimental: printed decision aid<br>receive printed decision aid | Behavioral: printed screening decision aid<br>* a booklet form of screening decision aid containing information of cervical cancer screening options<br>|
| Experimental: mobile decision aid<br>receive mobile decision aid | Behavioral: mobile screening decision aid<br>* a mobile app format of screening decision aid containing information of cervical cancer screening options<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk perception | 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. | baseline and 2 weeks after intervention | 
| screening decision: choice predisposition | 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'). | baseline and 2 weeks after intervention | 
| screening decision: choice question | 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. | baseline and 2 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, screening, South Asians, ethnic minority, decision aid