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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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

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

25 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    September 22, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Chinese University of Hong Kong
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    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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