NCT04479605已完成不适用
Values and Options in Cancer Care 2.0 (VOICE 2.0): Building on Lessons Learned to Improve Communication and Illness Understanding in Cancer Patients and Their Caregivers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Intervention Acceptability
研究概览
简要总结
The purpose of this study is to develop and test a new communication intervention, "Values and Options in Cancer Care 2.0" (VOICE 2.0), which involves oncologist training, patient and caregiver coaching, and caregiver support.
The VOICE 2.0 intervention was developed by members of the study team to improve communication among oncologists, patients with cancer, and caregivers. Researchers have found that clear communication about the patient's disease can help with the planning of that patient's future care and improve the well-being of both the patient and his or her caregiver. The long-term goals of developing and testing VOICE 2.0 include improving the care and respecting the wishes of cancer patients, and helping those patients and their caregivers have an improved quality of life during their experience with cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ONCOLOGISTS:
- •As per self-report, medical oncologist providing care to patients with gastrointestinal, genitourinary, gynecologic, lung, or hematologic cancers at MSK
- •As per self-report, not planning to leave MSK in the next six months
- •As per self-report, willing to be audio-recorded for Post-Training Follow-Up Interview
- •Per medical record and/or self-report, a patient of an oncologist participating in this study
- •As per medical record and/or self-report, diagnosis of:
- •a hematologic cancer with disease progression following second-line treatment that is not eligible for transplant; OR
- •stage III or IV gastrointestinal, genitourinary, gynecologic, or lung cancer
- •As per medical record and/or self-report, fluent in English
- •As per medical record and/or self-report, age 18 or older
- •As 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) who is willing and able to participate in the study
- •As per self-report, residency in New York or ability to complete sessions in New York to ensure that provision of intervention is covered by the professional licenses of interventionists (i.e., social workers licensed in New York State)
- •As per self-report, able to communicate over video-conference and phone for sessions
- •As per self-report, willing to be audio-recorded for assessments and study sess
- •CAREGIVERS:
- •As per patient report, is a primary informal caregiver ("a family member, partner, friend, or other individual involved with your health care issues, preferably someone who comes to physician appointments with you") for an MSK patient
- •As per self-report, fluent in English
- •As per self-report, age 18 or older
- •As per self-report, ability to complete sessions in a state the interventionists are legally allowed to practice in (i.e., social workers licensed in New York or New Jersey State; states with shared license laws)
- •As per self-report, able to communicate over video-conference and phone for sessions
- •As per self-report, willing to be audio-recorded for assessments and study sessions ** Language verification: For both patients and caregivers, prior to enrollment, all will be asked the following two questions by an CRC to verify English fluency necessary for participation in the study:
- •How well do you speak English? (must respond "Very 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)
排除标准
- •Score >4 on Short Portable Mental Status Questionnaire
- •As per self-report, feels too weak or cognitively impaired to participate in the intervention and complete the assessments
- •As per medical record or self-report, receiving hospice care at the time of enrollment
- •CAREGIVERS:
- •Score >4 on Short Portable Mental Status Questionnaire
- •As per self-report, feels too weak or cognitively impaired to participate in the intervention and complete the assessments
- •As per medical record or self-report, receiving hospice care at the time of enrollment
- •As per patient or self-report, supports the patient in a professional role
结局指标
主要结局
Intervention Acceptability
时间窗: 7 weeks
Intervention Acceptability will be assessed with Likert scale items with responses that range from 1 to 5 with higher scores indicating greater acceptability.
Feasibility will be assessed by rates of accrual, retention, and intervention completion
时间窗: 10 weeks
次要结局
- Concordant illness understanding (oncologists, patients, caregivers)(7 weeks)
- Communicational self-efficacy(7 weeks)
- Patient-caregiver communication quality(7 weeks)
- Psychological distress(7 weeks)
- Patient/caregiver-oncologist relationship strength(7 weeks)
- Meaning and purpose (patients, caregivers)(7 weeks)
研究者
研究点 (1)
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