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AzTrials

Breast CancerTICAANCT02803593

To Enhance Breast Cancer Survivorship of Asian Americans

A study testing Technology-based information and coaching/support program and American Cancer Society information on breast cancer in people with Breast Cancer, run by Emory University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Technology-based information and coaching/support program and American Cancer Society information on breast cancer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
2 sitesUnited States
Study dates
Jun 2016to 9 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Duke University, School of Nursing

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the detailed description

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
Breast Cancer
Being tested
Technology-based information and coaching/support program, American Cancer Society information on breast cancer
Keywords
technology-based intervention, Asian American, survivorship
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technology-based information and coaching/support programBehavioural

    Also called TICAA

    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 cancerBehavioural

    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.

Study groups in NCT02803593
Study groupRoleWhat they receive
ControlActive comparatorAsian 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.
Receives: Behavioral: American Cancer Society information on breast cancer
TICAA InterventionExperimentalAsian 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.
Receives: Behavioral: Technology-based information and coaching/support program; Behavioral: American Cancer Society information on breast cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Month 1, Month 3

  2. 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.

    Measured: Baseline, Month 1, Month 3

  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.

    Measured: Baseline, Month 1, Month 3

Secondary outcomes (6)

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

    Attitudes related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Attitudes section of this questionnaire includes 6 items scaled from -3 to 3, where -3 is the most negative score and 3 is the most positive score. There are also 7 qualitative questions. The total score for the scaled items ranges from -18 to 18 and higher scores indicate a better attitude towards breast cancer survivorship.

    Measured: Baseline, Month 1, Month 3

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

    Perceived barriers related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Perceived Barriers section of this questionnaire includes 16 items where responses are given on a 4-point scale where 1 = never and 4 = always. Total scores range from 16 to 64 and higher scores indicate greater perceived barriers related to breast cancer survivorship.

    Measured: Baseline, Month 1, Month 3

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

    Social influences related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Social Influences section of this questionnaire includes 3 items where responses are given on a 7-point scale where 1 = disapproval from social support and 7 = approval from social support. Total scores range from 3 to 21 and higher scores indicate greater positive support from social influences.

    Measured: Baseline, Month 1, Month 3

  4. Cancer Behavior Inventory-Brief Version (CBI-B) Score

    Self-efficacy related to breast cancer survivorship is measured using the Cancer Behavior Inventory-Brief Version (CBI-B). The CBI-B has 12 items assessing the degree of confidence respondents have with certain coping behaviors on a scale from 1 (not at all confident) to 9 (totally confident). Total scores range from 12 to 108 where higher scores indicate greater self-efficacy concerning cancer behaviors.

    Measured: Baseline, Month 1, Month 3

  5. Personal Resource Questionnaire (PRQ-2000) Score

    The Personal Resource Questionnaire (PRQ-2000) is a 15-item survey asking how much participants agree or disagree with statements related to social resources on a scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 15 to 105 and higher scores indicate greater social resources.

    Measured: Baseline, Month 1, Month 3

  6. Perceived Isolation Scale (PIS) Score

    The Perceived Isolation Scale (PIS) includes 9 items asking questions about how social connectedness. Responses are rated on a 3-point scale where 1 = hardly ever, 2 = some of the time, and 3 = often. The total score is the average of the responses to the PIS items and ranges from 1 to 3 with lower scores indicating greater social connectedness.

    Measured: Baseline, Month 1, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion9 Jun 2021
  4. Study completion9 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02803593
Sponsor's protocol ID
IRB00117270
Other IDs
R01CA203719-01
Acronym
TICAA
Status last verified
Jun 2022
First submitted
14 Jun 2016
Last updated
29 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40359896

  • 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.

    PubMed 37838727

Questions about this trial

What is this clinical trial studying?

A study testing Technology-based information and coaching/support program and American Cancer Society information on breast cancer in people with Breast Cancer, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Support Care Needs Survey (SCNS) Score (time frame: Baseline, Month 1, Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02803593, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.

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