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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06069648
• Other study ID #: HMRFSADA
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 11, 2024
• Est. completion date: March 10, 2026

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Dorothy Chan
• Phone: +85239438165
• Email: dorothycns[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: March 10, 2026
• Est. primary completion date: March 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• printed screening decision aid
a booklet form of screening decision aid containing information of cervical cancer screening options
• a leaftlet
a leaflet containing information about healthy lifestyles
• mobile screening decision aid
a mobile app format of screening decision aid containing information of cervical cancer screening options

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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