Clinical trial NCT02803593: To Enhance Breast Cancer Survivorship of Asian Americans
Official title: To Enhance Breast Cancer Survivorship of Asian Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: technology-based intervention
Asian American
survivorship
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-17
Enrollment: 199
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Support Care Needs Survey (SCNS) Score
timeFrame: Baseline, Month 1, Month 3
measure: Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score
timeFrame: Baseline, Month 1, Month 3
measure: Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score
timeFrame: Baseline, Month 1, Month 3
Secondary outcomes:
measure: Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
timeFrame: Baseline, Month 1, Month 3
measure: Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers
timeFrame: Baseline, Month 1, Month 3
measure: Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences
timeFrame: Baseline, Month 1, Month 3
measure: Cancer Behavior Inventory-Brief Version (CBI-B) Score
timeFrame: Baseline, Month 1, Month 3
measure: Personal Resource Questionnaire (PRQ-2000) Score
timeFrame: Baseline, Month 1, Month 3
measure: Perceived Isolation Scale (PIS) Score
timeFrame: Baseline, Month 1, Month 3
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Durham
country: United States
facility: Duke University, School of Nursing
state: North Carolina
Study officials:
affiliation: Emory University
name: Eun-Ok Im, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: