- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02803593
To Enhance Breast Cancer Survivorship of Asian Americans (TICAA)
2022년 6월 28일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
199
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University, School of Nursing
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Support Care Needs Survey (SCNS) Score
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Eun-Ok Im, PhD, MPH, Emory University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 6월 1일
기본 완료 (실제)
2021년 6월 9일
연구 완료 (실제)
2021년 6월 9일
연구 등록 날짜
최초 제출
2016년 6월 14일
QC 기준을 충족하는 최초 제출
2016년 6월 14일
처음 게시됨 (추정)
2016년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 6월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 6월 28일
마지막으로 확인됨
2022년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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American Cancer Society information on breast cancer에 대한 임상 시험
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