To Enhance Breast Cancer Survivorship of Asian Americans

NCT02803593 | Completed Results DMC

• 2 other identifiers: IRB00117270R01CA203719-01
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

technology-based intervention; Asian American; survivorship

Outcome Measures

Primary Outcomes (3)

• Support Care Needs Survey (SCNS) Score

  The SCNS uses 57 items to measure how much help the respondent needs. Responses are given on a scale from 1 to 5 where 1 = no help is needed and 5 = high need for help. Total scores range from 57 to 285 and higher scores indicate greater need for help.

  Baseline, Month 1, Month 3

• Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score

  Physical and psychological symptoms are assessed using the Memorial Symptom Assessment Scale-Short Form (MSAS-SF). The MSAS-SF asks if the respondent has experienced any of 32 specific symptoms during the past week, with the opportunity for the participant to enter additional symptoms. The degree of distress experienced by 28 of the symptoms is measured on a scale from 0 (not at all) to 4 (very much). The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.

  Baseline, Month 1, Month 3

• Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score

  Quality of life is assessed using the FACT-B. The FACT-B includes 41 items which are responded to on a scale from 0 to 4, where 0 = not at all and 4 = very much. The total score ranges from 0 to 164 and higher scores indicate better quality of life.

  Baseline, Month 1, Month 3

Secondary Outcomes (6)

• Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes

  Baseline, Month 1, Month 3

• Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers

  Baseline, Month 1, Month 3

• Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences

  Baseline, Month 1, Month 3

• Cancer Behavior Inventory-Brief Version (CBI-B) Score

  Baseline, Month 1, Month 3

• Personal Resource Questionnaire (PRQ-2000) Score

  Baseline, Month 1, Month 3

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Behavioral: American Cancer Society information on breast cancer

TICAA Intervention

EXPERIMENTAL

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.

Behavioral: Technology-based information and coaching/support program; Behavioral: American Cancer Society information on breast cancer

Interventions

Technology-based information and coaching/support program 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.

Also known as: TICAA

TICAA Intervention

American Cancer Society information on breast cancer 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.

Control; TICAA Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Those under 21 years old are excluded because their cancer experience would be different from adults

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Duke University, School of Nursing

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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.

  PMID: 40359896 DERIVED

• 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.

  PMID: 37838727 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Eun Ok Im
• Organization: Emory University

eun.ok.im@emory.edu

404-712-9805

Study Officials

• Eun-Ok Im, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: June 29, 2022
• Results First Posted: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)