Trial of Meaning Centered Psychotherapy for Mexican Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
研究概览
简要总结
The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Investigators also want to learn what participants and providers think about the therapy, including how the therapy is designed, outside factors, available resources, and how the people involved affect how well MCP-L works.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Eligibility Criteria:
- •A patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener and suicide risk assessment.
- •Inclusion Criteria:
- •EMR Criteria
- •- Documentation of Disease
- •Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis)
- •Definition of Disease [or Measurable Disease]
- •Diagnosed with stages III or IV
- •Prior Treatment
- •Receiving ambulatory care at INCan
- •Self-Report Criteria
- •Age ≥ 18 years
- •Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
- •Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
- •Providing care (or services) to Mexican cancer patients at INCan
- •Has access to internet and an electronic device
- •Agrees to be audio-recorded
排除标准
- •EMR Criteria
- •Prior Treatment
- •Received psychological or psychiatric care at INCan in the last 3 months
- •In the judgment of the treating physician, protocol investigators, and/or study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and/or study participation
- •Diagnosed with a serious psychiatric condition
- •Self-Report Criteria
- •Received psychological or psychiatric care outside of INCan in the last 3 months
- •Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale
- •Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?"
- •Provider Eligibility Criteria:
- •Inclusion Criteria Self-Report Criteria
- •Age ≥ 18 years
- •Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
- •Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
- •Providing care (or services) to Mexican cancer patients at INCan
- •Has access to internet and an electronic device
- •Agrees to be audio-recorded
研究组 & 干预措施
Control Intervention
Cognitive Behavioral Therapy (CBT)
Experimental Intervention
Meaning-Centered Psychotherapy for Latinos (MCP-L)
干预措施: Meaning-Centered Psychotherapy for Latinos /MCP-L (Behavioral)
结局指标
主要结局
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
时间窗: 3 months
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 3-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
时间窗: 1 month
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 1-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
次要结局
未报告次要终点