To Enhance Breast Cancer Survivorship of Asian Americans

Breast Cancer Clinical Trial

— TICAA  

Official title:

To Enhance Breast Cancer Survivorship of Asian Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803593
• Other study ID #: IRB00117270
• Secondary ID: R01CA203719-01
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 9, 2021

Study information

• Verified date: June 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• American Cancer Society information on breast cancer
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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Duke University, School of Nursing	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Baseline, Month 1, Month 3
Secondary	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.	Baseline, Month 1, Month 3
Secondary	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.	Baseline, Month 1, Month 3
Secondary	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.	Baseline, Month 1, Month 3
Secondary	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.	Baseline, Month 1, Month 3
Secondary	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.	Baseline, Month 1, Month 3