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- Ensaio Clínico NCT03726619
e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English
This research is being done to learn more about whether or not Korean American women will improve the screening practices for breast and cervical cancer if subjects receive education and follow-up from community health workers. The education materials may be given via online or in-person. Primary Hypothesis: e-CHEC-uP will be as efficacious as the original CHEC-uP in promoting mammogram and Pap test screening among Korean immigrant women (KIW) at 6 months.
Objectives: (1) To develop a web-based platform of the health literacy education component of the original CHEC-uP intervention; (2) To evaluate the acceptability and usability of the web version of the health literacy education in a user testing sample of 10 KIW; and (3) To conduct a pilot study to test the preliminary efficacy of the web version of CHEC-uP (e-CHEC-uP) in 40 KIW.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 21-65 years
- Self-identified as a Korean American woman
- Overdue for a mammogram (40-65 years of age only) or a Pap test**
- Able to read and write Korean or English
- Willing to provide written consent to allow the researchers to audit medical records for mammography and Pap test use
Exclusion Criteria:
- A cancer diagnosis
- Being pregnant
- An acute and/or terminal condition (e.g., life expectancy of less than 6 months or last cancer treatment within the last 5 years)
- Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment) or other conditions that preclude participation in the study activities
- Had undergone a hysterectomy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: e-CHEC-uP
Group 1 will receive the education study intervention after the first baseline questionnaire.
Participants will be asked to take part in a one-time, 1 to 1.5-hour online education on breast and cervical cancer prevention followed by monthly phone calls and navigation assistance by a community health worker to help address any barriers in order to help receive a mammogram or a Pap test.
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One time online-based education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months
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Comparador Ativo: CHEC-uP
Group 2 will receive a similar education intervention but the education is offered face-to-face instead.
Participants will be asked to take part in a one-time, 1 to 1.5-hour face-to-face education on breast and cervical cancer prevention followed by monthly phone calls and navigation assistance by a community health worker.
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One time face-to-face education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Age-appropriate mammogram screening test
Prazo: 6 months
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Patient medical records will be reviewed to confirm the receipt of mammogram and whether the age at which it was received is "appropriate". According to the American Cancer Society (ACS), Mammograms received from ages 40 to 54 years (annual screening) and from ages 55 years onward (biennial screening) will be deemed appropriate. It is optional to continue annual screening after age 54 years based on a woman's choice. The investigators will compare the proportion of women in each group (e-CHEC-uP intervention vs. CHEC-uP) who completed mammogram at 6 months. |
6 months
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Age-appropriate Pap screening test
Prazo: 6 months
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Patient medical records will be reviewed to confirm the receipt of Pap test and whether the age at which it was received is "appropriate". According to the American Cancer Society (ACS), Pap tests received from ages 21 to 65 years once every 3 years will be deemed appropriate. The investigators will compare the proportion of women in each group (e-CHEC-uP intervention vs. CHEC-uP) who completed Pap test at 6 months. |
6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Health Literacy as assessed by a 49-item instrument
Prazo: 6 months
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Scoring of the health literacy instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores can range from 0 to 49 with higher scores indicating higher health literacy.
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6 months
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Breast Cancer knowledge as assessed by a 25-item instrument
Prazo: 6 months
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Scoring of the breast cancer knowledge instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores for breast cancer knowledge will range from 0 to 25.
Higher scores indicate higher breast cancer knowledge.
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6 months
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Cervical Cancer knowledge as assessed by 10-item instrument
Prazo: 6 months
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Scoring of the cervical cancer knowledge instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores for cervical cancer knowledge will range from 0 to 10. Higher scores indicate higher cervical cancer knowledge.
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6 months
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Cancer screening-related self-efficacy as assessed by 8-item scale
Prazo: 6 months
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Scoring of the cancer screening-related self-efficacy is to assess one's belief about ability to get cancer screening.
The 8-item scale (developed by the study team) scoring ranges from "not at all confident" coded as 1 to "very confident" coded as 4 for each item.
Total scores will range from 8 to 32 with higher scores indicating higher self-efficacy.
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6 months
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Han HR, Huh B, Kim MT, Kim J, Nguyen T. Development and validation of the assessment of health literacy in breast and cervical cancer screening. J Health Commun. 2014;19 Suppl 2(0 2):267-84. doi: 10.1080/10810730.2014.936569.
- Park S, Chang S, Chung C. Effects of a cognition-emotion focused program to increase public participation in Papanicolaou smear screening. Public Health Nurs. 2005 Jul-Aug;22(4):289-98. doi: 10.1111/j.0737-1209.2005.220404.x.
- McCance KL, Mooney KH, Smith KR, Field R. Validity and reliability of a breast cancer knowledge test. Am J Prev Med. 1990 Mar-Apr;6(2):93-8.
- Hwang DA, Lee A, Song JM, Han HR. Recruitment and Retention Strategies Among Racial and Ethnic Minorities in Web-Based Intervention Trials: Retrospective Qualitative Analysis. J Med Internet Res. 2021 Jul 12;23(7):e23959. doi: 10.2196/23959.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00180383
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Ensaios clínicos em e-CHEC-uP
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Weill Medical College of Cornell UniversityNational Institute on Aging (NIA)RecrutamentoEsgotamento do cuidadorEstados Unidos
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Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)Ativo, não recrutandoTranstorno obsessivo-compulsivo | Transtornos de ansiedade | Transtorno de Estresse Pós-TraumáticoEstados Unidos
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University of ChicagoUniversity of California, Los Angeles; Oak Foundation; UBS Optimus Foundation; Trickle... e outros colaboradoresConcluídoAbuso infantil | Maltrato infantilBurkina Faso
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Shannon E. Sauer-ZavalaConcluídoDesordem depressiva | Transtorno obsessivo-compulsivo | Transtornos de ansiedade | Transtorno de Estresse Pós-TraumáticoEstados Unidos
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air up GmbHCitruslabsRecrutamento
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University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical... e outros colaboradoresRecrutamento
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University of South FloridaTemple University; National Institute on Disability, Independent Living, and... e outros colaboradoresRecrutamentoDoença mental | Distúrbios Comportamentais | Diagnóstico Psiquiátrico | Distúrbios psiquiátricos | Doença Mental Grave | Doenças Psiquiátricas | Doença psiquiátricaEstados Unidos
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University of WarsawAinda não está recrutandoDistúrbios de Ajustamento
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Oregon Health and Science UniversityTexas A&M University; University of North Carolina, GreensboroAtivo, não recrutandoAtividade físicaEstados Unidos
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Johns Hopkins UniversityDonaghue Medical Research FoundationAtivo, não recrutando