Translating a Stress Management Program for Latinas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Change Emotional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
研究概览
简要总结
The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II) cognitive-behavioral stress management program through a 6-month RCT with 150 Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving quality of life (QoL) and reducing distress, compared to a usual care control group (that is offered the program at the end of the 6 months). The investigators will also test the effects of the program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Trained Latinas, called Compañeras (Companions), who have had breast cancer deliver the stress management program in-person to Spanish-speaking Latinas with breast cancer.
详细描述
The purpose of this study is to adapt Nuevo Amanecer (NA-I) for use in rural populations and test the effects of the new adapted program, NA-II, in a 6-month RCT among 150 rural, low literacy Latinas with non-metastatic breast cancer. Primary outcomes will consist of quality of life and distress. In an ancillary study, the investigators will compare the intervention and wait-list control groups on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Finally, to facilitate statewide dissemination of Nuevo Amanecer-II (NA-II), the investigators will develop a guide to implementation for community-based organizations.
The investigators will adapt NA-I to be appropriate for rural and low-literacy Latinas with breast cancer. Needed program adaptations will be identified through a formative evaluation consisting of semi-structured interviews with key informants (e.g., rural Latina breast cancer survivors, advocates, health care providers) and iterative consultations with community representatives in three rural areas with large Latino populations. Results will be applied by the study team and community advisors to adapt NA-I to create NA-II and create the implementation guide.
The investigators will identify key individual, organizational, and community factors that facilitate implementation and support scalability and statewide dissemination through a process evaluation where the investigators will track key implementation activities and debrief program participants, interventionists, and advocates. Products will include NA-II interventionist and participant manuals and a guide to implementation for organizations seeking to replicate the program.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-identifies as Latina
- •Diagnosed with Stage 0, I, II, or III (non-metastatic) breast cancer
- •Primarily Spanish-speaking, or Spanish monolingual
- •Aged 18 or older
- •Living in surrounding areas of Tulare (Visalia, Dinuba), Santa Cruz (Eastside Santa Cruz, Watsonville, Freedom), or Imperial Valley (El Centro) counties, California.
排除标准
- •Terminal illness
- •Stage IV breast cancer (distant metastasis)
研究组 & 干预措施
Nuevo Amancer-II Stress Management Program
Nuevo Amanecer-II (NA-II) is a 10-week peer-delivered cognitive-behavioral stress management program. Participants receive the stress management program as soon as possible after randomization.
干预措施: Nuevo Amancer-II Stress Management Program (Behavioral)
Wait-list Control Group
Waits six months and at the end of the six months is offered the option of receiving the NA-II program.
结局指标
主要结局
Change Emotional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
时间窗: Baseline and 6 month assessment
Change in Functional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
时间窗: Baseline and 6 month assessment
Change in Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
时间窗: Baseline and 6 month assessment
Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
时间窗: Baseline and 6 month assessment
Change in Social/Family Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
时间窗: Baseline and 6 month assessment
Change in Breast Cancer Concerns Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
时间窗: Baseline and 6 month assessment
次要结局
- Change in diurnal cortisol rhythm to assess regulatory patterns through saliva samples collected over 3 days, 3 times/day.(Baseline and 6 month assessment)
- Change Anxiety Score, a Subscale of the Brief Symptom Inventory (BSI)(Baseline and 6 month assessment)
- Change Perceived Stress Scale (PSS-10) Score(Baseline and 6 month assessment)
- Change MOS Health Distress Scale Score(Baseline and 6 month assessment)
- Change Somatization Score, a Subscale of the Brief Symptom Inventory (BSI)(Baseline and 6 month assessment)
- Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score(Baseline and 6 month assessment)
- Change in long-term stress level measured by cortisol levels collected from hair sample.(Baseline and 6 month assessment)
- Change in telomere length, a measure of biological aging, in DNA collected from saliva sample.(Baseline and 6 month assessment)