Cervical CancerEarly Phase 1NCT03961412
A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
A Early Phase 1 study testing family-based intervention and Participant only intervention in people with Cervical Cancer and Healthy Women, run by University of Nevada, Reno.
Trial summary
The purpose of this study is to find out the impact of the involvement of an influential person(s) (e.g., spouse, partners, parents, children, friends) on Pap test screening intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap test screening among Chinese American immigrant… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Healthy Women
- What is being tested?
- family-based intervention and Participant only intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jun 2024
- Phase
- Early Phase 1
- 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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a first-generation Chinese American
- no previous cervical cancer screening within the past 3 years
- no total hysterectomy
- no history of cervical cancer
- able to read English, Simple Chinese, or Traditional Chinese.
Who cannot join
- Not a Chinese American immigrant
- Had total hysterectomy
- Had history of cervical cancer
- Not able to read English or Chinese
About this study
Official title: Evaluation of A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
The purpose of this study is to find out the impact of the involvement of an influential person(s) (e.g., spouse, partners, parents, children, friends) on Pap test screening intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap test screening among Chinese American immigrant women. These data specific to the impact of the involvement of an influential person on Pap test screening could be used to develop successful cancer prevention programs that target the specific needs of Chinese populations.
Read the detailed description
The importance of the support from family, spouse, friends, or significant others has been noted among Chinese American immigrant women (CAIW), but little attention has been paid to the effects of family-based (FB) interventions, especially for cervical cancer screening. Understanding the role of CAIW's family in promoting Pap screening and other influences can lead to the creation of more culturally appropriate screening interventions. The objective of this study is to test the effects of a FB intervention on Pap test intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap tests among under-screened CAIW aged 21-65. This pilot test of the FB intervention will be conducted using a randomized controlled design with two groups only, experimental and control groups. Interventions will be delivered by bilingual and bicultural CAIW trained facilitators. Post-test and follow-up telephone surveys will be conducted at 2 weeks and 6 months after the intervention.
- Conditions
- Cervical Cancer, Healthy Women
- Being tested
- family-based intervention, Participant only intervention
- 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.
family-based interventionBehavioural
The participants will identify their accompanying influential person(s) (e.g., spouse, partners, parents, children, friends) with whom they will be attending the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends.
Participant only interventionBehavioural
Only participant will attend the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends.
| Study group | Role | What they receive |
|---|---|---|
| family-based intervention + education materials | Experimental | The participants will identify their accompanying influential person (e.g., spouse, partners, parents, children, friends) with whom they will be attending the 1.5-2 hour face-to-face education session on cervical cancer and screening. Their accompanying influential person is eligible if they are (a) aged 18 or older and (b) willing to participate in the study. Receives: Behavioral: family-based intervention |
| women only intervention + education materials | Active comparator | Only the participants will attend the 1.5-2 hour face-to-face intervention on cervical cancer and screening. Receives: Behavioral: Participant only intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Receiving a Pap Test
Change from baseline in use of a Pap test 2 weeks after intervention
Measured: 2 weeks after intervention
Change in Receiving a Pap Test
Change from baseline in use of a Pap test 6 months after intervention
Measured: 6 months after intervention
Change in Intention to Receive a Pap Test
Change from baseline in intention to receive a Pap test 2 weeks after intervention
Measured: 2 weeks after intervention
Change in Intention to Receive a Pap Test
Change from baseline in intention to receive a Pap test 6 months after intervention
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study startJul 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (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.
- 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Chen Tung, San Jose State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961412
- Sponsor's protocol ID
- 1440348-1
- Status last verified
- Nov 2020
- First submitted
- 17 May 2019
- Last updated
- 24 Nov 2020
- Results posted
- 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 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
- ClinicalTrials.gov ID
- NCT03961412
- Acronym / sponsor ID
- 1440348-1
- Conditions
- Cervical Cancer, Healthy Women
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 23 May 2019 (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.
The purpose of this study is to find out the impact of the involvement of an influential person(s) (e.g., spouse, partners, parents, children, friends) on Pap test screening intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap test screening among Chinese American immigrant women. These data specific to the impact of the involvement of an influential person on Pap test screening could be used to develop successful cancer prevention programs that target the specific needs of Chinese populations.
Detailed description
The importance of the support from family, spouse, friends, or significant others has been noted among Chinese American immigrant women (CAIW), but little attention has been paid to the effects of family-based (FB) interventions, especially for cervical cancer screening. Understanding the role of CAIW's family in promoting Pap screening and other influences can lead to the creation of more culturally appropriate screening interventions. The objective of this study is to test the effects of a FB intervention on Pap test intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap tests among under-screened CAIW aged 21-65. This pilot test of the FB intervention will be conducted using a randomized controlled design with two groups only, experimental and control groups. Interventions will be delivered by bilingual and bicultural CAIW trained facilitators. Post-test and follow-up telephone surveys will be conducted at 2 weeks and 6 months after the intervention.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| family-based intervention + education materials | Experimental | Behavioral: family-based interventionThe participants will identify their accompanying influential person (e.g., spouse, partners, parents, children, friends) with whom they will be attending the 1.5-2 hour face-to-face education session on cervical cancer and screening. Their accompanying influential person is eligible if they are (a) aged 18 or older and (b) willing to participate in the study. |
| women only intervention + education materials | Active comparator | Behavioral: Participant only interventionOnly the participants will attend the 1.5-2 hour face-to-face intervention on cervical cancer and screening. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a first-generation Chinese American
- no previous cervical cancer screening within the past 3 years
- no total hysterectomy
- no history of cervical cancer
- able to read English, Simple Chinese, or Traditional Chinese.
Key exclusion criteria (4 listed)
- Not a Chinese American immigrant
- Had total hysterectomy
- Had history of cervical cancer
- Not able to read English or Chinese
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 |
|---|---|---|
| family-based interventionThe participants will identify their accompanying influential person(s) (e.g., spouse, partners, parents, children, friends) with whom they will be attending the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends. | Behavioural | family-based intervention + education materials |
| Participant only interventionOnly participant will attend the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends. | Behavioural | women only intervention + education materials |
Primary outcome
Change in Receiving a Pap Test
Time frame: 2 weeks after intervention
Change from baseline in use of a Pap test 2 weeks after intervention
Change in Receiving a Pap Test
Time frame: 6 months after intervention
Change from baseline in use of a Pap test 6 months after intervention
Change in Intention to Receive a Pap Test
Time frame: 2 weeks after intervention
Change from baseline in intention to receive a Pap test 2 weeks after intervention
Change in Intention to Receive a Pap Test
Time frame: 6 months after intervention
Change from baseline in intention to receive a Pap test 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing family-based intervention and Participant only intervention in people with Cervical Cancer and Healthy Women, run by University of Nevada, Reno.
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 5 inclusion and 4 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 24 Nov 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Receiving a Pap Test (time frame: 2 weeks after intervention). The study lists 4 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 24 Nov 2020.