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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
University of Nevada, Reno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    May 17, 2019
    Last Updated
    November 21, 2020
    Sponsor
    University of Nevada, Reno
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    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

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

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