A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
Primary Purpose
Cervical Cancer, Healthy Women
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
family-based intervention
Participant only intervention
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not a Chinese American immigrant
- Had total hysterectomy
- Had history of cervical cancer
- Not able to read English or Chinese
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
family-based intervention + education materials
women only intervention + education materials
Arm Description
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.
Only the participants will attend the 1.5-2 hour face-to-face intervention on cervical cancer and screening.
Outcomes
Primary Outcome Measures
Change in Receiving a Pap Test
Change from baseline in use of a Pap test 2 weeks after intervention
Change in Receiving a Pap Test
Change from baseline in use of a Pap test 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
Change in Intention to Receive a Pap Test
Change from baseline in intention to receive a Pap test 6 months after intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT03961412
First Posted
May 17, 2019
Last Updated
November 21, 2020
Sponsor
University of Nevada, Reno
1. Study Identification
Unique Protocol Identification Number
NCT03961412
Brief Title
A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
Official Title
Evaluation of A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Reno
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Healthy Women
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
family-based intervention + education materials
Arm Type
Experimental
Arm Description
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.
Arm Title
women only intervention + education materials
Arm Type
Active Comparator
Arm Description
Only the participants will attend the 1.5-2 hour face-to-face intervention on cervical cancer and screening.
Intervention Type
Behavioral
Intervention Name(s)
family-based intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Participant only intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Receiving a Pap Test
Description
Change from baseline in use of a Pap test 2 weeks after intervention
Time Frame
2 weeks after intervention
Title
Change in Receiving a Pap Test
Description
Change from baseline in use of a Pap test 6 months after intervention
Time Frame
6 months after intervention
Title
Change in Intention to Receive a Pap Test
Description
Change from baseline in intention to receive a Pap test 2 weeks after intervention
Time Frame
2 weeks after intervention
Title
Change in Intention to Receive a Pap Test
Description
Change from baseline in intention to receive a Pap test 6 months after intervention
Time Frame
6 months after intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Not a Chinese American immigrant
Had total hysterectomy
Had history of cervical cancer
Not able to read English or Chinese
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
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