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To Enhance Breast Cancer Survivorship of Asian Americans (TICAA)

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ClinicalTrials.gov Identifier: NCT02803593
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 at three time points (pre-test, post1-month, and post 3-month).

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Technology-based information and coaching/support program Not Applicable

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 (PSs), 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: To Enhance Breast Cancer Survivorship of Asian Americans
Actual Study Start Date : June 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
165 Asian American breast cancer survivors (55 per sub-ethnic group) who do not use the TICAA, but use the information on breast cancer by the American Cancer Society (ACS)
Experimental: Intervention (TICAA)
165 Asian American breast cancer survivors (55 per sub-ethnic group) who use the intervention (TICAA) 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.
Behavioral: 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.
Other Name: TICAA




Primary Outcome Measures :
  1. Changes in the needs for help measured using the Support Care Needs Survey-34 Short Form (SCNS-34SF) [ Time Frame: Baseline (pre-test) to Time Points 1 (post 1-month; primary) and 2 (post 3-months; secondary) ]
  2. Changes in physical and psychological symptoms measured using the Memorial Symptom Assessment Scale-Short Form (MSAS-SF) [ Time Frame: baseline (pre-test) to Time Points 1 (post 1-month; primary) and 2 (post 3-months; secondary) ]
  3. Changes in quality of life measured using the Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) [ Time Frame: baseline (pre-test) to Time Points 1 (post 1-month; primary) and 2 (post 3-months; secondary) ]

Secondary Outcome Measures :
  1. Changes in attitudes related to breast cancer survivorship measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) [ Time Frame: baseline (pre-test) to Time Points 1 (post 1-month; primary) ]
  2. Changes in self-efficacy related to breast cancer survivorship measured using the Cancer Behavior Inventory (CBI) [ Time Frame: baseline (pre-test) to Time Points 1 (post 1-month; primary) ]
  3. Changes in perceived barriers related to breast cancer survivorship measured using the subscale on perceived barriers of the QASPS [ Time Frame: baseline (pre-test) to Time Points 1 (post 1-month; primary) ]
  4. Changes in social influences related to breast cancer survivorship measured using the subscale on social influences of the QASPS, the Personal Resource Questionnaire (PRQ-2000), and the Perceived Isolation Scale (PIS) [ Time Frame: baseline (pre-test) to Time Points 1 (post 1-month; primary) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be included in the Internet survey if they (by self-report) are 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 in the past 5 years
  • can read and write English, Mandarin Chinese, Korean or Japanese
  • have access to the Internet through computers or mobile devices (smart phones and tablets).
  • Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past 5 years will be included because technology-based programs are used by those in all stages of treatment and because those who have survived more than 5 years would have different needs from those who have survived less than 5 years. A specific fatigue level was not set because compared to those who do not have fatigue or have a low level of fatigue, those with a medium or high levels of fatigue would be more likely to need support through technology-based programs.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803593


Contacts
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Contact: Eun-Ok Im, PhD, MPH 919 668 3838 eun-ok.im@duke.edu

Locations
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United States, North Carolina
Duke University, School of Nursing Recruiting
Durham, North Carolina, United States, 27710
Contact: Eun-Ok Im, PhD, MPH    919-668-3838    eun-ok.im@duke.edu   
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eun-Ok Im, PhD, MPH Duke University (DukeUMC)

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02803593     History of Changes
Other Study ID Numbers: Pro00071993
R01CA203719-01 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Duke University:
a technology-based intervention
Asian American
survivorship
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases