Clinical trial NCT06069648: Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening
Official title: Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
screening
South Asians
ethnic minority
decision aid
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 270
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: decisional conflict
timeFrame: baseline and 2 weeks after intervention
measure: cervical cancer screening uptake
timeFrame: 3 months after intervention
Secondary outcomes:
measure: risk perception
timeFrame: baseline and 2 weeks after intervention
measure: screening decision: choice predisposition
timeFrame: baseline and 2 weeks after intervention
measure: screening decision: choice question
timeFrame: baseline and 2 weeks after intervention
Other outcomes:
Locations:
Study officials:
References: