NCT06305741招募中不适用
Managing Anxiety From Cancer (MAC): Evaluation of a Tailored Anxiety Intervention for Latino Older Adults With Cancer and Their Caregivers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- percentage of participants to complete all study procedures
研究概览
简要总结
The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older Adults with Cancer (OAC)
- •As per medical record or self-report, is currently age 65 years or older
- •As per medical record or self-report, currently receiving active cancer treatment OR is within eighteen months of completing active treatment which includes surgery, chemotherapy, radiation, and immunotherapy.
- •As per self-report, identifies as Latino and/or Hispanic Ethnicity
- •Per self-report, has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) age 40 or older who is willing and able to participate in the study ; if a patient does not have a primary informal caregiver or if the caregiver does not or cannot participate, but meets all other inclusion criteria they will be allowed to enroll in the study
- •Scores ≥6 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
- •Per self-report, fluent in English and/or Spanish** ** Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:
- •How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- •What is your preferred language for healthcare? (must respond English and/or Spanish)
- •Per OAC report, is primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for the eligible OAC patient
- •As per self-report, is age 40 years or older
- •Per self-report, fluent in English and/or Spanish** ** Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:
- •How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- •What is your preferred language for healthcare? (must respond English and/or Spanish)
排除标准
- •As per medical record or self-report, currently receiving psychotherapy
- •As per medical record or self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
- •As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- •Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
- •Per research staff judgment and/or self-report, too ill or weak to complete study procedures
- •Per medical record or self-report, receiving hospice care at the time of enrollment
- •As per self-report, currently receiving psychotherapy
- •As per self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
- •As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- •Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
- •Per research staff judgment and/or self-report, too ill or weak to complete study procedures
研究组 & 干预措施
Latino caregivers and the Latino older adults with cancer (OACs)
Experimental
The intervention, MAC, is a seven-session (45- 60 minutes per session) psychotherapy intervention delivered via videoconference and/or telephone by licensed social workers. All sessions will be audio-recorded. MAC content, structure, and length are consistent with core components of cognitive behavioral therapy (CBT) (Freeman, 2004).
干预措施: Managing Anxiety from Cancer (MAC) (Other)
结局指标
主要结局
percentage of participants to complete all study procedures
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (7)
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