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临床试验/NCT01599520
NCT01599520已完成不适用

Stress Management Training for Latinas Receiving Chemotherapy

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

Cancer patients receiving chemotherapy experience a number of aversive symptoms that are accompanied by declines in physical and mental well-being. Although the benefits of stress management training interventions on quality of life are well documented, there are no published studies examining the efficacy of these interventions among Hispanic women and Latinas (hereafter referred to as Latinas) receiving chemotherapy. This dearth of research reflects the general lack of stress management interventions for cancer patients whose preferred language is Spanish. Simply translating existing English-language interventions into Spanish may seem to be a solution for the lack of Spanish-language stress management interventions. This approach, however, does not take into account cultural values, beliefs and situational realities that are likely to contribute to patients' uptake of health promoting behaviors. The proposed research seeks to address this gap by evaluating a stress management training intervention developed specifically for Latinas beginning chemotherapy for cancer.

In response to the identified need, the investigators created a Spanish-Language Self-Administered Stress Management Training (SL-SAT) intervention "Cómo tratar el estrés durante la quimioterapia" ("How to manage stress during chemotherapy"). The intervention is based on an English-language self-administered stress management training intervention the investigators previously developed and showed to be efficacious in a randomized controlled trial. Development of the Spanish-language intervention was the result of extensive use of ethnographic and learner verification methods, guided by a community-based participatory research approach. Similar to the English-language version, the SL-SAT intervention consists of a digital video disc(DVD), booklet, and audio compact disc (CD), and provides instruction in three well-established stress management techniques: deep breathing; progressive muscle relaxation and guided imagery; and use of coping self-statements. The proposed study will evaluate the efficacy of this transcreated intervention in a randomized controlled trial involving Spanish-speaking Latinas about to begin chemotherapy for cancer. Following a baseline assessment, participants will receive usual care or usual care plus the SL-SAT intervention. Participants will be reassessed on study measures approximately 7 and 13 weeks after the baseline assessment.

详细描述

Specific aims of the project are:

  1. To evaluate the impact of Cómo tratar el estrés durante la quimioterapia on quality of life during chemotherapy relative to usual care only. Consistent with prior research, the investigators hypothesize that the intervention will result in better psychological and spiritual well-being and less anxiety, depression, and cancer-related distress.
  2. To investigate the mechanism by which Cómo tratar el estrés durante la quimioterapia improves quality of life during chemotherapy. Based on relevant theory and prior research, the investigators hypothesize that improvement in perceived self-efficacy in managing stress will explain beneficial effects of the intervention on quality of life outcomes.
  3. To examine whether communication and sociocultural factors associated with the acculturation process moderate the impact of Cómo tratar el estrés durante la quimioterapia on quality of life. Based on relevant theory and prior research, the investigators hypothesize that, among women who receive the intervention, those who have a stronger preference for communicating and receiving information in Spanish will benefit more.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Be at least 18 years old
  • Be female
  • Self-identify as Hispanic or Latina
  • Be capable of speaking and reading Spanish
  • Be diagnosed with cancer
  • Be scheduled to start outpatient intravenous (IV) chemotherapy for reasons other than symptom palliation at Moffitt Cancer Center (MCC)
  • Be scheduled to receive chemotherapy on one of the five schedules specified in Table 3
  • Have not received chemotherapy in the past 2 months
  • Have no documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with participation (e.g., blindness, deafness, psychosis, or dementia)
  • Be able to provide written informed consent

排除标准

  • No exclusion criteria

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: Baseline, Week 5-7, Week 13 (to evaluate change)

This 14-item measure has been used widely in behavioral oncology research because it does not assess somatic symptoms of anxiety and depression (e.g., fatigue) that may be confounded with disease- or treatment-related symptoms. The validated Spanish version will be used in the current study. Analyses will focus on the total score as a primary outcome.

Functional Assessment of Cancer Therapy--General Version

时间窗: Baseline, 5-7 weeks, 13 weeks (to evaluate change)

This 27-item measure has been used to assess health-related quality of life in patients with many different types of cancer. The validated Spanish version will be used in the current study.The FACT-G yields scores for physical, social/family, emotional, and functional well-being. Analyses will focus on emotional well-being scores as a primary outcome; other scales will be examined as secondary outcomes.

Functional Assessment of Chronic Illness-Spiritual Well-being Scale (FACIT-SP)

时间窗: Baseline, 5-7 weeks, 13 weeks (to evaluate change)

This 12-item scale is a valid and reliable measure of spiritual well-being in cancer patients. The validated Spanish version will be used in the current study. The FACIT-Sp yields scores for meaning/peace and faith as well as a total score. Analyses will focus on total FACIT-Sp scores as a primary outcome.

Impact of Event-Revised Intrusion Subscale (IES-R)

时间窗: Baseline, Week 5-7, Week 13 (to evaluate change)

The 8-item Intrusion Subscale from the IES-R measures intrusive thoughts, such as dreams, images, and reminders of a stressful event. In the present study, as in other research, it will be keyed to "your cancer and cancer diagnosis" in order to provide a measure of cancer-related distress. The IES-R has been validated in numerous populations and is widely used in cancer research. The validated Spanish version will be used in the current study.

次要结局

  • Measure of Current Status (MOCS)(Baseline, 5-7 weeks, 13 weeks)
  • Memorial Symptom Assessment Scale-Short Form (MSAS-SF)(Baseline, 5-7 weeks, 13 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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