NCT03961412

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

May 17, 2019

Last Update Submit

November 21, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Receiving a Pap Test

    Change from baseline in use of a Pap test 2 weeks after intervention

    2 weeks after intervention

  • Change in Receiving a Pap Test

    Change from baseline in use of a Pap test 6 months after intervention

    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

    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

    6 months after intervention

Study Arms (2)

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.

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.

Behavioral: Participant only intervention

Interventions

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.

family-based intervention + education materials

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.

women only intervention + education materials

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not a Chinese American immigrant
  • Had total hysterectomy
  • Had history of cervical cancer
  • Not able to read English or Chinese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD, RN, FAAN

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 23, 2019

Study Start

July 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share