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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06069648
Collaborator
(none)
270
3
27.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: printed screening decision aid
  • Behavioral: a leaftlet
  • Behavioral: mobile screening decision aid
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening: A Randomised Controlled Trial
Anticipated Study Start Date :
Nov 11, 2023
Anticipated Primary Completion Date :
Mar 10, 2026
Anticipated Study Completion Date :
Mar 10, 2026

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: control

factsheet about healthy living

Behavioral: a leaftlet
a leaflet containing information about healthy lifestyles

Experimental: printed decision aid

receive printed decision aid

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

Experimental: mobile decision aid

receive mobile decision aid

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

Outcome Measures

Primary Outcome Measures

  1. decisional conflict [baseline and 2 weeks after intervention]

    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.

  2. cervical cancer screening uptake [3 months after intervention]

    The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?

Secondary Outcome Measures

  1. risk perception [baseline and 2 weeks after intervention]

    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.

  2. screening decision: choice predisposition [baseline and 2 weeks after intervention]

    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').

  3. screening decision: choice question [baseline and 2 weeks after intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 64 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dorothy Ngo Sheung Chan, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT06069648
Other Study ID Numbers:
  • HMRFSADA
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dorothy Ngo Sheung Chan, Assistant Professor, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023