A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women

Cervical Cancer Clinical Trial

Official title:

Evaluation of A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03961412
• Other study ID #: 1440348-1
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2022
• Est. completion date: June 2024

Study information

• Verified date: November 2020
• Source: University of Nevada, Reno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 224
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Healthy Women
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• family-based intervention
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 intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Reno

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Receiving a Pap Test	Change from baseline in use of a Pap test 2 weeks after intervention	2 weeks after intervention
Primary	Change in Receiving a Pap Test	Change from baseline in use of a Pap test 6 months after intervention	6 months after intervention
Primary	Change in Intention to Receive a Pap Test	Change from baseline in intention to receive a Pap test 2 weeks after intervention	2 weeks after intervention
Primary	Change in Intention to Receive a Pap Test	Change from baseline in intention to receive a Pap test 6 months after intervention	6 months after intervention