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Effects of Cancer Symptoms on Caregivers

2022年2月14日 更新者:M.D. Anderson Cancer Center

Effects of Cancer Symptoms on Minority Caregivers

The primary objectives are to:

1.1 identify and compare the experiences of minority and nonminority caregivers, including the prevalence and severity of physical (fatigue, sleep disturbance) and psychologic (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden; and to

1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the patient's symptom's at multiple time points over the patient's treatment regimen for advanced solid tumors (lung, breast, cervical, and others).

A secondary objective is to:

1.3 describe the experience of being a minority (African American/Black or Latino) or nonminority person caring for a medically underserved patient with advanced solids tumors (lung, breast, cervical, or others) over the course of the patient's treatment regimen and follow-up clinic visits.

研究概览

详细说明

Caregiver:

If you choose to take part in this study, you will be asked to complete 3 study visits over a period of about 20 weeks (the first visit, followed by 2 more visits, usually 3-8 weeks apart). During the first and third visits, you will be asked to take part in an interview that will include questions about your experience as a caregiver to a patient with cancer. The interview will last about 30-45 minutes and will be tape recorded. The text of the interviews will be copied from the tapes to a written format. The study staff will review the content to look for key caregiver concerns and experiences. The PI and study staff will be the only ones who will have access to the tapes and transcripts. All tapes will be destroyed after the study is finished.

You will also be asked to complete some brief surveys about your physical and psychological health, your reactions to being a caregiver, and your beliefs about symptoms and their control. It will take about 30-45 minutes to complete the surveys, each time.

Each study visit will take about 60-90 minutes. If you can not come to the clinic, trained research study staff will contact you by telephone or by a home visit (with your permission) to complete the surveys and interview. After the last of the 3 study visits, your participation will be ended in this study.

This is an investigational study. Up to 125 participants will take part in this multicenter study at 4 sites: Lyndon Baines Johnson Hospital, Ben Taub General Hospital, MD Anderson, and locations in the community identified by the participant and the study team. Up to 40 will be enrolled at MD Anderson.

Patient:

If you choose to take part in this study, you will be asked to complete 3 study visits over a period of about 20 weeks (the first visit, followed by 2 more visits, usually 3-8 weeks apart). During the visits, you will also be asked to complete some surveys about your physical and psychological health, your reactions to your caregiver, and your beliefs about symptoms and their control. It will take about 30 minutes to complete the surveys each time.

Each study visit will take about 45 minutes. If you can not come to the clinic, trained research study staff will contact you by telephone or by a home visit (with your permission) to complete the surveys and interview. After the last of the 3 study visits, your participation in this study will end.

This is an investigational study. Up to 125 patients will take part in this multicenter study at 4 sites: Lyndon Baines Johnson Hospital, Ben Taub General Hospital, MD Anderson and locations in the community identified by the participant and study team. Up to 40 will be enrolled at MD Anderson.

研究类型

观察性的

注册 (实际的)

199

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

    • Florida
      • Miami、Florida、美国、33136
        • Jackson Memorial
    • Texas
      • Houston、Texas、美国、77030
        • University of Texas MD Anderson Cancer Center
      • Houston、Texas、美国、77030
        • Ben Taub General Hospital
      • Houston、Texas、美国、77026
        • Lyndon Baines Johnson Hospital

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Three groups of caregivers: African American, Latinos, and white non-Latinos.

描述

Inclusion Criteria:

  1. Caregiver inclusion criteria includes: provides care and/or assistance to a patient receiving new or current treatment - Single or combined chemotherapy, radiotherapy, and/or targeted therapy for advanced solid tumors (lung, breast, cervical, and other).
  2. 18 years of age or older;
  3. self-identified as African-American/Black, Latino, or white, non-Latino;
  4. able to speak English or Spanish (as applicable);
  5. able to read and complete forms or be willing to have the forms read to them by a trained interviewer;
  6. accessible through personal or telephone contact for the duration of the study.
  7. Patient inclusion criteria: Receiving new or current treatment - Single or combined - chemotherapy, radiotherapy, and/or targeted therapy for advanced solid tumors (lung, breast, cervical, and others). Criteria 2-6 are the same as listed under Caregiver Criteria.

Exclusion Criteria: None

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

队列和干预

团体/队列
干预/治疗
African American caregivers
African American caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
其他名称:
  • 调查问卷
Latino caregivers
Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
其他名称:
  • 调查问卷
White non-Latino caregivers
White non-Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
其他名称:
  • 调查问卷

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Difference in reduction in psychological (depression, anxiety, stress) and physical symptoms (fatigue, sleep disturbance) between 3 groups of caregivers: African American, Latinos, and white non-Latinos
大体时间:20 weeks
20 weeks

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:Guadalupe Palos, DrPH、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2006年1月26日

初级完成 (实际的)

2022年1月20日

研究完成 (实际的)

2022年1月20日

研究注册日期

首次提交

2006年7月12日

首先提交符合 QC 标准的

2006年7月12日

首次发布 (估计)

2006年7月14日

研究记录更新

最后更新发布 (实际的)

2022年2月16日

上次提交的符合 QC 标准的更新

2022年2月14日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2005-0404
  • 5 KO7 CA 102482-02 (其他赠款/资助编号:NCI)

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.

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