Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening
Primary Purpose
Cervical Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
printed screening decision aid
a leaftlet
mobile screening decision aid
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer focused on measuring cervical cancer, screening, South Asians, ethnic minority, decision aid
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
control
printed decision aid
mobile decision aid
Arm Description
factsheet about healthy living
receive printed decision aid
receive mobile decision aid
Outcomes
Primary Outcome Measures
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.
cervical cancer screening uptake
The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?
Secondary Outcome Measures
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.
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').
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.
Full Information
NCT ID
NCT06069648
First Posted
September 22, 2023
Last Updated
October 4, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT06069648
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 11, 2023 (Anticipated)
Primary Completion Date
March 10, 2026 (Anticipated)
Study Completion Date
March 10, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer, screening, South Asians, ethnic minority, decision aid
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
factsheet about healthy living
Arm Title
printed decision aid
Arm Type
Experimental
Arm Description
receive printed decision aid
Arm Title
mobile decision aid
Arm Type
Experimental
Arm Description
receive mobile decision aid
Intervention Type
Behavioral
Intervention Name(s)
printed screening decision aid
Intervention Description
a booklet form of screening decision aid containing information of cervical cancer screening options
Intervention Type
Behavioral
Intervention Name(s)
a leaftlet
Intervention Description
a leaflet containing information about healthy lifestyles
Intervention Type
Behavioral
Intervention Name(s)
mobile screening decision aid
Intervention Description
a mobile app format of screening decision aid containing information of cervical cancer screening options
Primary Outcome Measure Information:
Title
decisional conflict
Description
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.
Time Frame
baseline and 2 weeks after intervention
Title
cervical cancer screening uptake
Description
The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
risk perception
Description
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.
Time Frame
baseline and 2 weeks after intervention
Title
screening decision: choice predisposition
Description
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').
Time Frame
baseline and 2 weeks after intervention
Title
screening decision: choice question
Description
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.
Time Frame
baseline and 2 weeks after intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorothy Chan
Phone
+85239438165
Email
dorothycns@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening
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