A Research Study for Latina Women After Breast Cancer Treatment
2020년 8월 11일 업데이트: Betina Yanez, Northwestern University
An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life Among Hispanic Women Completing Active Treatment for Breast Cancer
The purpose of this study is to examine the effects of a developed psychosocial eHealth intervention on the proposed primary outcomes, health-related quality of life and symptom burden, among Hispanic breast cancer survivors.
The intervention components include breast cancer knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over an 8-week period.
Participants are randomized into either an intervention application (described above) or a control application (health information and health promotion strategies). Aside from using the Smartphone application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 8-week follow-up.
연구 개요
상태
완전한
상세 설명
Among Hispanics, the largest and fastest growing ethnic minority group in the U.S., cancer is the leading cause of death whereas cardiovascular disease is the leading cause of death for African Americans and non-Hispanic Whites (NHWs).
Hispanics also experience substantially lower rates of 5-year cancer-specific survival relative to non-Hispanic Whites (NHWs).
Hispanic cancer patients in the U.S. also report significantly worse cancer-related symptom burden and health-related quality of life (HRQOL) than NHWs, even after adjusting for socioeconomic factors.
Despite this, very few randomized, intervention studies have specifically targeted cancer-related symptom burden and HRQOL outcomes among Hispanic women, especially during the period at the end of active treatment which is a critical period to intervene to provide skills and tools to assist with this transition.
Innovative approaches to providing interventions such as Smartphone technology are especially important for this patient population.
Ubiquitous Smartphone use among ethnic minorities in the US provide a unique opportunity to implement a pragmatic technology- and evidence-based psychosocial intervention that overcomes some access to care barriers as well as time and logistical constraints.
Furthermore, given that Hispanics own Smartphones and seek health information online from a mobile device at similar or higher rates than other groups in the U.S., Smartphone interventions offer an opportunity to overcome obstacles to accessing resources and services that can be culturally informed and provide skills to improve symptom burden and HRQOL.
This study aims to create and evaluate a culturally informed eHealth psychoeducational and psychosocial intervention for English or Spanish-speaking Hispanic women completing treatment for breast cancer.
This intervention is grounded in evidence-based paradigms to improve the proposed Primary Outcomes: Cancer-Related Symptom Burden and HRQOL and the proposed Secondary Outcomes: usability and markers the intervention use.
This study is designed in two-phases to develop and test a Smartphone-based intervention that can be disseminated to cancer survivors at a relatively low cost.
The first phase is intended to create an eHealth intervention designed to improve cancer-related symptom burden and HRQOL.
The second phase is designed as an 8-week randomized trial intended to evaluate the eHealth intervention when compared to a control condition.
It is hypothesized that the eHealth intervention will significantly improve cancer-related symptom burden and HRQOL compared to the control condition.
연구 유형
중재적
등록 (실제)
80
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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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Chicago, Illinois, 미국, 60608
- University of Illinois Cancer Center
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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:
- Female
- Diagnosis of breast cancer, non-metastatic, stage 0-IIIA; for women diagnosed with stage 0, either radiation or chemotherapy is required as an additional treatment to surgery
- Completed active treatment for breast cancer (surgery, chemotherapy and/or radiation therapy, current hormonal treatment allowed)
- No current evidence of disease
- Within 3 to 24 months post-active treatment [e.g., surgery, chemotherapy, radiation, or combination of the two or three]
- at least 21 years of age
- Able to speak and read English or Spanish
- Able to provide informed consent
- Elevated score on breast cancer symptom burden and HRQoL, measured by the Functional Assessment of Cancer Therapy-Breast using an established cut-off score for clinically meaningful, compromised HRQoL
- Self-identified Hispanic/Latina ethnicity.
Exclusion Criteria:
- Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia)
- Illicit substance or alcohol dependence
- Suicidal ideation, plan, intent
- Alzheimer's, dementia or history of stroke
- Scheduled reconstruction surgery within 1 month of any study procedures or involvement.
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: My Guide (psychoeducation & self-management program)
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"My Guide" is a Smartphone application incorporating elements informed by the extant literature, designed to improve quality of life and symptom burden among Hispanic breast cancer survivors.
"My Guide" components are designed to improve breast cancer knowledge, cancer-relevant self-efficacy, stress and symptom management skills, Both intervention and active comparator conditions are administered to participants for 8 weeks.
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활성 비교기: My Health (health education program)
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"My Health" is a health promotion Smartphone application with health education content on nutrition, and general advice on lifestyle choices and prevention.
The "My Health" control content was based on similar content tested in other psychosocial interventions with cancer survivors.
Both intervention and active comparator conditions are administered to participants for 8 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B)
기간: HRQoL will be first assessed at baseline (T1), initial HRQoL changes will be assessed at 6 weeks post-baseline (T2), and finally any additional HRQoL changes will be captured 8 weeks post-baseline (T3)
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The FACT-B has been used extensively to measure HRQoL, and has been translated to and validated in Spanish.
The FACT-B assesses participant's wellbeing in physical, emotional, social, functional, and breast cancer related concerns in the last seven days using a five-point response scale.
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HRQoL will be first assessed at baseline (T1), initial HRQoL changes will be assessed at 6 weeks post-baseline (T2), and finally any additional HRQoL changes will be captured 8 weeks post-baseline (T3)
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Symptom Burden will be evaluated with The Breast Cancer Prevention Trial symptom questionnaire (BCPT)
기간: Symptom Burden will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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The BCPT measures participants' symptom burden.
The BCPT asks participants to report their level of discomfort with 25 breast cancer related symptoms during the past four weeks using a five-point response scale.
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Symptom Burden will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
기간: Cancer-Specific Distress will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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The IES is made up of two subscales measuring the frequency of intrusion and avoidance experiences after a stressful event.
The IES has been widely used among patients diagnosed with cancer and has been translated and validated with Spanish-speaking participants.
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Cancer-Specific Distress will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire
기간: Breast Cancer Knowledge will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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This questionnaire has been tested with Spanish-speaking Hispanic breast cancer survivors, it is made up of 16 true and false questions regarding general breast cancer knowledge.
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Breast Cancer Knowledge will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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Breast Cancer Related Communication and Attitudinal Self-Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
기간: Breast Cancer Related Communication and Attitudinal Self-Efficacy will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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The CASE-cancer questionnaire is made up various subscales measuring breast cancer related communication and attitudinal self-efficacy.
Each question asks participants to use a four-point response scale to agree or disagree with statements regarding their level of confidence with different skills.
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Breast Cancer Related Communication and Attitudinal Self-Efficacy will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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Stress Management Skills will be evaluated with the Brief COPE Inventory
기간: Stress Management Skills will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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The Brief COPE is made up of various subscales measuring different ways of coping.
Each question as participants to rate how often they have used each coping mechanism in response to their breast cancer experience.
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Stress Management Skills will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 8 weeks post-baseline (T3)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Betina Yanez, Ph.D., Northwestern University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2015년 3월 25일
기본 완료 (실제)
2019년 4월 24일
연구 완료 (실제)
2019년 5월 15일
연구 등록 날짜
최초 제출
2018년 4월 24일
QC 기준을 충족하는 최초 제출
2018년 8월 21일
처음 게시됨 (실제)
2018년 8월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 8월 11일
마지막으로 확인됨
2020년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- STU00201961
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .