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

Early Phase 1

• Conditions: Healthy Women; Cervical Cancer
• Interventions: Behavioral: Participant only intervention; Behavioral: family-based intervention

• Registration Number: NCT03961412
• Lead Sponsor: University of Nevada, Reno

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.

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-21
• Last Update Posted: 2020-11-24
• Study Start: 2022-07
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
women only intervention + education materials	Participant only intervention	Only the participants will attend the 1.5-2 hour face-to-face intervention on cervical cancer and screening.
family-based intervention + education materials	family-based intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Receiving a Pap Test	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	6 months after intervention	Change from baseline in intention to receive a Pap test 6 months after intervention