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Clinical Trials/NCT03961412
NCT03961412UnknownPhase 1

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

University of Nevada, Reno0 sites224 target enrollmentStarted: July 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Enrollment
224
Primary Endpoint
Change in Receiving a Pap Test

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: family-based intervention (Behavioral)

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.

Intervention: Participant only intervention (Behavioral)

Outcomes

Primary Outcomes

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: 6 months after intervention

Change from baseline in intention to receive a Pap test 6 months after intervention

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 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wei-Chen Tung

Associate Professor, PhD, RN, FAAN

San Jose State University

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