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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06069648
Enrollment
270
Registered
2023-10-06
Start date
2024-07-11
Completion date
2026-03-10
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

cervical cancer, screening, South Asians, ethnic minority, decision aid

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.

Interventions

BEHAVIORALprinted screening decision aid

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

BEHAVIORALa leaftlet

a leaflet containing information about healthy lifestyles

BEHAVIORALmobile screening decision aid

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
decisional conflictbaseline and 2 weeks after intervention16-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.
cervical cancer screening uptake3 months after interventionThe participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?

Secondary

MeasureTime frameDescription
risk perceptionbaseline and 2 weeks after interventionOne 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.
screening decision: choice predispositionbaseline and 2 weeks after interventionChoice 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 questionbaseline and 2 weeks after interventionThe 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.

Contacts

Primary ContactDorothy Chan
dorothycns@cuhk.edu.hk+85239438165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026