Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Depressive Symptoms
研究概览
简要总结
The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients' and their family caregivers' psychological wellbeing and overall quality of life.
详细描述
To enhance the accessibility and scalability for future research, both the interventions (FFM and AC) will be delivered via videoconferencing. To increase the generalizability of the findings, a multi-site enrollment recruitment strategy will be used to enroll a diverse (including underserved) patient population. The program will be delivered in both English and Spanish and a varied social economic population will be enrolled in 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
- 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
- •Be diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer
- •Be without disease progression for at least 3 months based on surveillance CT imaging
- •Have an ECOG performance status of ≤2
- •Have a family caregiver willing to participate
- •Both patient and caregiver must meet all the following criteria:
- •Be ≥18 years old
- •Be able to read and speak English or Spanish.
- •Be able to provide informed consent
- •Additionally, either the patient and/or caregiver must:
- •Have a NCCN Distress Thermometer score of ≥4
排除标准
- •A patient who meets the following criteria will be excluded from participation in this study:
- •Have cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist
- •3.3 Vulnerable Populations This study is designed for individuals who are at least 18 years of age, and there is no upper age limit. Children under the age of 18 will not be included. First and foremost, it is unlikely that a minor is diagnosed with a metastatic solid tumor. It is also unlikely that a minor serves as the primary family caregiver of a patient with cancer. Additionally, the intervention is designed for adults, and the assessment tools are not validated for minors. While pregnant caregivers (self-identified) are study eligible, we will also exclude pregnant patients (medical notes).
- •3.4 Recruitment/Screening Process Eligible study participants (i.e. cancer patients) will be identified using the electronic clinic appointment systems on their tumor characteristics (i.e. cancer type and stage) and date of birth (i.e. minimum 18 years old). Potential patients and caregivers will be approached during patients' appointment at an outpatient oncology appointment, screened for eligibility, and consented. Since this is a family-based intervention, it is possible that caregivers will not be present during the patients' clinic visits. If so, patients will be asked for permission to contact the caregiver via phone to obtain consent.
研究组 & 干预措施
Attention Control
Participants will take part in a meditation program. As part of this program, participants will complete up to 4 meditation sessions with a trained counselor. Participants should attend each session together as a family. All sessions will be online by videoconference using Zoom.
干预措施: Meditation Program (Behavioral)
Behavioral Intervention (FFM Program)
Participants will take part in a discussion program. Participants will be asked to complete 4 discussion sessions with a trained counselor over a course of a 4 week period. Participants should attend each session together as a family.
干预措施: Meditation Program (Behavioral)
Usual Care
All participants will receive cancer treatment per usual care (UC).
干预措施: Meditation Program (Behavioral)
结局指标
主要结局
Depressive Symptoms
时间窗: Through study completion; an average of 1 year.
Participants will complete the Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item self-report measure focusing on the affective component of depression, which is appropriate as patients may experience somatic symptoms due to treatment toxicities rather than depression.
次要结局
未报告次要终点