To Enhance Breast Cancer Survivorship of Asian Americans (TICAA)
2022年6月28日 更新者:Eun-Ok Im、Emory University
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
199
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University, School of Nursing
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Control
Asian 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.
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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.
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实验性的:TICAA Intervention
Asian 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.
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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.
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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Support Care Needs Survey (SCNS) Score
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Cancer Behavior Inventory-Brief Version (CBI-B) Score
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Personal Resource Questionnaire (PRQ-2000) Score
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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Perceived Isolation Scale (PIS) Score
大体时间:Baseline, Month 1, Month 3
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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.
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Baseline, Month 1, Month 3
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Eun-Ok Im, PhD, MPH、Emory University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月1日
初级完成 (实际的)
2021年6月9日
研究完成 (实际的)
2021年6月9日
研究注册日期
首次提交
2016年6月14日
首先提交符合 QC 标准的
2016年6月14日
首次发布 (估计)
2016年6月17日
研究记录更新
最后更新发布 (实际的)
2022年6月29日
上次提交的符合 QC 标准的更新
2022年6月28日
最后验证
2022年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.