NCT03168971已完成不适用
Managing Anxiety From Cancer (MAC): A Pilot Randomized Controlled Trial of a Psychological Intervention for Anxiety in Older Adults With Cancer and Their Caregivers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Anxiety sub-scale of the Hospital Anxiety and Depression Scale
研究概览
简要总结
This study is being done to test the effects of Managing Anxiety from Cancer (MAC) therapy on anxiety compared to usual care, in patients and their caregivers. MAC is different from usual care because it uses a plan for managing anxiety that has been shown to work in previous studies. MAC has designed this plan for people 65 years of age and older. MAC also includes the primary caregiver which has been shown to help patients manage their anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 or older
- •Confirmed diagnosis of breast, lymphoma, genitourinary, thoracic, gynecological or gastrointestinal cancer, currently on active treatment or within six months of completion of treatment
- •As determined by the patient's primary oncologist and/or study staff, physically and cognitively able to complete study procedures
- •English fluent (as per self-reported fluency of "very well")**
- •In the judgment of the investigators and/or consenting professional, able to perform informed consent
- •Has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) who is willing and able to participate in the study
- •As part of the patient-caregiver dyad, at least one member reports elevated anxiety as defined by a score of 8 or greater on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
- •As per self-report, residency in New York or ability to complete sessions in New York
- •Able to communicate over the phone for sessions
- •Willingness to be audio-recorded for assessments and, if applicable, study sessions
- •CAREGIVERS:
- •Age 21 or older
- •In the judgment of the investigators and/or consenting professional, able to perform informed consent
- •As part of the patient-caregiver dyad, at least one member reports elevated anxiety as defined by a score of 8 or greater on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
- •English fluent (as per self-reported fluency of "very well")**
- •Is a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for an MSK patient
- •As per self-report, residency in New York or ability to complete sessions in New York
- •Able to communicate over the phone for sessions
- •Willingness to be audio-recorded for assessments and, if applicable, study sessions
排除标准
- •Endorsing active suicidal ideation on the item, "In light of your current circumstances, have you ever had thoughts of killing yourself?"
- •As per oncologist or self-report, too weak or cognitively impaired to participate in the intervention and complete the assessments
- •Per self-report/screening measures, has received cognitive-behavioral therapy since cancer diagnosis
- •As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- •Anxiety due solely to a medical procedure as determined by a patient-report item on the screening questionnaire
- •CAREGIVERS:
- •Endorsing active suicidal ideation on the item, "In light of your current circumstances, have you ever had thoughts of killing yourself?"
- •Per self-report/screening measures, has received cognitive-behavioral therapy since patient"s cancer diagnosis
- •As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- •If female, currently pregnant
结局指标
主要结局
Anxiety sub-scale of the Hospital Anxiety and Depression Scale
时间窗: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Change in anxiety from baseline to follow-up
Hamilton Anxiety Rating Scale
时间窗: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Change in anxiety from baseline to follow-up
次要结局
- Distress Thermometer(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
- Caregiver Quality of Life-Cancer (caregivers only)(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
- Montgomery-Asberg Depression Scale(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
- Depression sub-scale of the Hospital Anxiety and Depression Scale(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
- Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only)(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
研究者
研究点 (1)
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