A Structured Multidisciplinary Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment & Their Caregivers: A Telemedicine Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Change in the participant's QOL at 4 weeks (end of the intervention)
研究概览
简要总结
This study will use video technology in conjunction with in-person participation. This is a pilot project, where all enrolled participants will receive the multidisciplinary intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend an in-person group session, and participants (patients and caregivers) from Mayo Clinic Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use of video conferencing. The goals are to examine feasibility (percent of eligible patients and caregivers who enroll), attrition, and adherence (attend at least four of the six sessions), to determine any differences between the two formats, and to examine potential QOL differences as a result of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18 years of age.
- •Ability to attend all treatment sessions and follow-up.
- •Ability to provide written informed consent.
- •Ability to participate in all aspects of the study.
- •Initial diagnosis of cancer must have been 12 months prior to study entry.
- •Intermediate to poor prognosis, defined as an expected 5-year survival of 0%-50% in the judgment of the physicians entering the patient on the study.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or
- •1 week of planned cancer treatment (radiation or chemotherapy) at Mayo Clinic.
- •Has a caregiver also willing to participate.
- •Willingness to get e-mail/text reminder to complete the follow-up survey or complete the follow-up survey with a study coordinator by phone.
排除标准
- •Expected survival of <6 months.
- •Active substance abuse (alcohol or drug).
- •Participation in other psycho-social research trials.
- •Active untreated thought disorder (bipolar illness, schizophrenia, etc.).
- •Untreated suicidal intent or plan.
- •In need of psychiatric hospitalization.
- •Recurrent disease after disease-free interval of >6 months.
- •Previous cancer 5 years (except non-melanoma skin cancer and/or second cancer diagnosed at approximately the same time as this cancer).
- •Use of Proton Beam Radiation.
研究组 & 干预措施
Quality of Life Counseling
干预措施: Quality of life counseling (Behavioral)
Quality of Life Counseling
干预措施: Video-conference quality of life counseling (Other)
结局指标
主要结局
Change in the participant's QOL at 4 weeks (end of the intervention)
时间窗: baseline, 4 weeks
Quality of Life, 0 to 10. 7 or higher is positive.
Change in the participant's QOL at 26 weeks
时间窗: baseline, 26 weeks
Quality of Life, 0 to 10. 7 or higher is positive.
次要结局
未报告次要终点