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

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ClinicalTrials.gov Identifier: NCT03961412
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Wei-Chen Tung, 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Healthy Women Behavioral: family-based intervention Behavioral: Participant only intervention Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: family-based intervention + education materials
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
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.

Active Comparator: women only intervention + education materials
Only the participants will attend the 1.5-2 hour face-to-face intervention on cervical cancer and screening.
Behavioral: 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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Wei-Chen Tung, Associate Professor, PhD, RN, FAAN, University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT03961412     History of Changes
Other Study ID Numbers: 1440348-1
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female