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To Enhance Breast Cancer Survivorship of Asian Americans (TICAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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) ]
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02803593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Enhance Breast Cancer Survivorship of Asian Americans
Official Title  ICMJE To Enhance Breast Cancer Survivorship of Asian Americans
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Technology-based information and coaching/support program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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'.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eun-Ok Im, PhD, MPH 919 668 3838 eun-ok.im@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02803593
Other Study ID Numbers  ICMJE Pro00071993
R01CA203719-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Eun-Ok Im, PhD, MPH Duke University (DukeUMC)
PRS Account Duke University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP