To Enhance Breast Cancer Survivorship of Asian Americans

NCT ID: NCT02803593

Last Updated: 2022-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-06-09

Brief Summary

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The purpose of this randomized intervention study is to test the efficacy of the technology-based information and coaching/support program for Asian American breast cancer survivors (TICAA) in enhancing the women's breast cancer survivorship experience.

Detailed Description

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Despite few studies on Asian American breast cancer survivors, it is well known that these women shoulder unnecessary burden of breast cancer because they rarely complain about symptoms or pain, delay seeking help, and rarely ask or get support due to their cultural values and beliefs and language barriers. This demonstrates a definite need for support in this specific population. However, survivorship programs that are increasingly instituted at cancer centers have serious impediments to providing information and coaching/support because of the lack of staff time and insurance reimbursement. Furthermore, the pressure of fast-paced clinical patient-provider interactions leaves little time for health care providers to provide up-to-date information and coaching or support for these women based on their cultural attitudes. All these circumstances necessitate an innovative and creative delivery method of information and coaching/support. A technology-based approach using computers and mobile devices (smart phones and tablets) promises to meet this necessity with high flexibility and accessibility, and minimizes the cost of the intervention in busy and costly health care settings. Also, a technology-based intervention that does not involve face-to-face interactions could work better for many women from cultures where breast cancer is still a stigmatizing experience. Therefore, based on preliminary studies, the research team has developed and pilot-tested a theory-driven technology-based information and coaching/support program that is culturally tailored to Asian American breast cancer survivors using multiple features. The purpose of the proposed randomized intervention study is to test the efficacy of the technology-based information and coaching/support program for Asian American breast cancer survivors (TICAA) in enhancing the women's breast cancer survivorship experience. The specific aims are to: a) determine whether the intervention group will show significantly greater improvements than the control group in primary outcomes (needs for help, physical and psychological symptoms, and quality of life) from baseline (pre-test) to Time Points 1 (post 1-month) and 2 (post 3-months); b) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences related to breast cancer survivorship) that mediate the intervention effects of the TICAA on the primary outcomes at the three time points (pre-test, post 1-month and post 3-months); and c) determine whether the effects of the TICAA on the primary outcomes are moderated by background characteristics and disease factors. The proposed study will be guided by the Bandura's Theory of Behavioral Change. This study adopts a randomized repeated measures pretest/posttest control group design in 330 Asian American breast cancer survivors. The long-term goals are to: (a) implement the program into various health care settings; (b) determine if the TICAA will lead to long-term improved health outcomes; and (c) fundamentally enhance the methodology/paradigm of culturally tailored technology-based interventions for ethnic minority groups of breast cancer survivors.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Asian American breast cancer survivors who do not use the TICAA, but use the information on breast cancer by the American Cancer Society (ACS). Participants are asked to use the online ACS resources for 3 months.

Group Type ACTIVE_COMPARATOR

American Cancer Society information on breast cancer

Intervention Type BEHAVIORAL

The American Cancer Society (ACS) webpage has a wide range of information on breast cancer including prevention, treatment, and ways to connect with breast cancer survivors.

TICAA Intervention

Asian American breast cancer survivors who use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants are asked to use the TICAA program for 3 months.

Group Type EXPERIMENTAL

Technology-based information and coaching/support program

Intervention Type BEHAVIORAL

The TICAA has three components in four languages (English, Mandarin Chinese, Korean, and Japanese): (a) social media sites; (b) interactive online educational sessions; and (c) online resources. The social media sites provide a mechanism by which participants can receive coaching/support from culturally matched peers and health care providers. The educational sessions provide information about general and sub-ethnic- specific topics related to breast cancer survivorship. The online resources include 35 Web links to resources related to breast cancer survivorship from scientific authorities and from general and sub-ethnic-specific health organizations/institutes.

American Cancer Society information on breast cancer

Intervention Type BEHAVIORAL

The American Cancer Society (ACS) webpage has a wide range of information on breast cancer including prevention, treatment, and ways to connect with breast cancer survivors.

Interventions

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Technology-based information and coaching/support program

The TICAA has three components in four languages (English, Mandarin Chinese, Korean, and Japanese): (a) social media sites; (b) interactive online educational sessions; and (c) online resources. The social media sites provide a mechanism by which participants can receive coaching/support from culturally matched peers and health care providers. The educational sessions provide information about general and sub-ethnic- specific topics related to breast cancer survivorship. The online resources include 35 Web links to resources related to breast cancer survivorship from scientific authorities and from general and sub-ethnic-specific health organizations/institutes.

Intervention Type BEHAVIORAL

American Cancer Society information on breast cancer

The American Cancer Society (ACS) webpage has a wide range of information on breast cancer including prevention, treatment, and ways to connect with breast cancer survivors.

Intervention Type BEHAVIORAL

Other Intervention Names

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TICAA

Eligibility Criteria

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Inclusion Criteria

* Self-reported Asian American women aged 21 years and older who identify their sub-ethnicity as Chinese, Korean, or Japanese
* Have had a breast cancer diagnosis
* Can read and write English, Mandarin Chinese, Korean or Japanese
* Have access to the Internet through computers or mobile devices (smart phones and tablets)

Exclusion Criteria

* Those under 21 years old are excluded because their cancer experience would be different from adults
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Eun-Ok Im

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eun-Ok Im, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

Duke University, School of Nursing

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Im EO, Chee W, Paul S, Kim SY, Choi MY, Mao JJ, Nguyen GT, Schapira MM, Ulrich CM, Yeo S, Deatrick JA, Inouye J, Ma G, Meghani S, Shin D, Bao T. Multiple dimensions of the quality of life among Asian American breast cancer survivors: The impact of a technology-based program. Breast. 2025 Aug;82:104490. doi: 10.1016/j.breast.2025.104490. Epub 2025 May 8.

Reference Type DERIVED
PMID: 40359896 (View on PubMed)

Im EO, Chee W, Paul S, Choi MY, Kim SY, Deatrick JA, Inouye J, Ma G, Meghani S, Nguyen GT, Schapira MM, Ulrich CM, Yeo S, Bao T, Shin D, Mao JJ. A randomized controlled trial testing a virtual program for Asian American women breast cancer survivors. Nat Commun. 2023 Oct 14;14(1):6475. doi: 10.1038/s41467-023-42132-6.

Reference Type DERIVED
PMID: 37838727 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA203719-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00117270

Identifier Type: -

Identifier Source: org_study_id

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