Meaning-Centered Psychotherapy to Meet Palliative Care Needs of Cancer Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Number of participants with improved primary outcomes
研究概览
简要总结
Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.
After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.
Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away.
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
- 是
入选标准
- •Age 18 or over;
- •As per self-report, a current caregiver to a patient with Stage III or IV solid tumor cancer currently receiving medical care of any kind (e.g., curative, palliative);
- •Experiences distress as evidenced by a score of 4 or greater on the Distress Thermometer (DT) and an indication that this distress is associated with caregiving;
- •As per self-report, can read and understand English;
- •As per self-report, residing in New York, New Jersey, Connecticut, or Florida, or have the ability to complete sessions while complying with current telehealth regulations.
排除标准
- •Participant does not have a reasonable understanding of the study activities by the judgment of the consenting professional;
- •Engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of treatment.
研究组 & 干预措施
Meaning-Centered Psychotherapy for Caregivers
Meaning-Centered Psychotherapy for Caregivers/MCP-C
干预措施: Meaning-Centered Psychotherapy for Caregivers (Behavioral)
Supportive Psychotherapy for Caregivers
Supportive Psychotherapy for Caregivers/SP-C standard of care
干预措施: Supportive Psychotherapy for Caregivers (Behavioral)
结局指标
主要结局
Number of participants with improved primary outcomes
时间窗: Up to 1 year
Evaluate the efficacy of MCP-C versus SP-C in improving primary outcomes (i.e., sense of meaning in life, spiritual well-being) immediately post-treatment and explore maintenance in gains up to 1 year.
Number of participants with improved primary outcomes
时间窗: Up to 1 year
Evaluate the efficacy of MCP-C versus SP-C in improving primary outcomes (i.e., sense of meaning in life, spiritual well-being) immediately post-treatment and explore maintenance in gains up to 1 year.
Life Attitude Profile-Revised (LAP-R)
时间窗: Up to 1 year
Life Attitude Profile-Revised (LAP-R) - used to measure sense of meaning in life. The LAP-R is a 48-item instrument. Each item is rated on a 7-point Likert scale ranging from "strongly agree" to "strongly disagree." Full scale ranges from 30 to 210 with a higher score indicating a greater sense of meaning in life and a more positive attitude towards life.
FACIT Spiritual Well-Being Scale (SWBS)
时间窗: Up to 1 year
The Spiritual Well-Being Scale (SWBS) - used to measure spiritual well-being. The SWBS is a 12-item instrument. Each item is scored from 1 to 5. Negatively worded items are reverse scored. The measure generates two sub-scales: Faith/Spirituality (0-16) and Meaning/Peace (0-32). Full scale ranges from 0 to 48. Higher scores indicate a greater sense of spiritual well-being.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Up to 1 year)
- Benefit Finding Scale (BFS)(Up to 1 year)
- Caregiver Reaction Assessment (CRA)(Up to 1 year)
- Duke-UNC Functional Social Support Questionnaire (FSSQ)(Up to 1 year)
研究者
Allison Applebaum
Professor
Icahn School of Medicine at Mount Sinai