Cervical CancerNCT06069648
Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening
A study testing printed screening decision aid, a leaftlet and mobile screening decision aid in people with Cervical Cancer, run by Chinese University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- printed screening decision aid, a leaftlet and mobile screening decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- NA
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening: A Randomised Controlled Trial
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).
Read more
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.
- Conditions
- Cervical Cancer
- Being tested
- printed screening decision aid, a leaftlet, mobile screening decision aid
- Keywords
- cervical cancer, screening, South Asians, ethnic minority, decision aid
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
printed screening decision aidBehavioural
a booklet form of screening decision aid containing information of cervical cancer screening options
a leaftletBehavioural
a leaflet containing information about healthy lifestyles
mobile screening decision aidBehavioural
a mobile app format of screening decision aid containing information of cervical cancer screening options
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | factsheet about healthy living Receives: Behavioral: a leaftlet |
| printed decision aid | Experimental | receive printed decision aid Receives: Behavioral: printed screening decision aid |
| mobile decision aid | Experimental | receive mobile decision aid Receives: Behavioral: mobile screening decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 2 weeks after intervention
cervical cancer screening uptake
The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?
Measured: 3 months after intervention
Secondary outcomes (3)
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.
Measured: baseline and 2 weeks after intervention
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').
Measured: baseline and 2 weeks after intervention
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.
Measured: baseline and 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start11 Jul 2024 (estimated)
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Ngo Sheung Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069648
- Sponsor's protocol ID
- HMRFSADA
- Status last verified
- Feb 2024
- First submitted
- 22 Sep 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06069648
- Acronym / sponsor ID
- HMRFSADA
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, screening, South Asians, ethnic minority, decision aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Jul 2024 (estimated)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Behavioral: a leaftletfactsheet about healthy living |
| printed decision aid | Experimental | Behavioral: printed screening decision aidreceive printed decision aid |
| mobile decision aid | Experimental | Behavioral: mobile screening decision aidreceive mobile decision aid |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| printed screening decision aida booklet form of screening decision aid containing information of cervical cancer screening options | Behavioural | printed decision aid |
| a leaftleta leaflet containing information about healthy lifestyles | Behavioural | control |
| mobile screening decision aida mobile app format of screening decision aid containing information of cervical cancer screening options | Behavioural | mobile decision aid |
Primary outcome
decisional conflict
Time frame: 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.
cervical cancer screening uptake
Time frame: 3 months after intervention
The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?
3 secondary outcomes
risk perception
Time frame: baseline and 2 weeks after intervention
screening decision: choice predisposition
Time frame: baseline and 2 weeks after intervention
screening decision: choice question
Time frame: baseline and 2 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing printed screening decision aid, a leaftlet and mobile screening decision aid in people with Cervical Cancer, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorothy Chan (+85239438165, dorothycns@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decisional conflict (time frame: baseline and 2 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.