Values and Options in Cancer Care 2 (VOICE 2) A Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Multiple-choice questions will measure fidelity
研究概览
简要总结
Primary Objective:
Aim 1: To evaluate the acceptability and feasibility of recruitment strategies for subjects for VOICE 2 intervention.
Secondary Objective:
Aim 2: To test the preliminary efficacy of VOICE 2 on oncologist-patient, patient-caregiver, and oncologist-caregiver concordant prognostic understanding, oncologist-patient and oncologist-caregiver therapeutic alliance, patient/caregiver depression/anxiety and death anxiety, and patient/caregiver meaning/purpose.
详细描述
The purpose of the research is to test whether the randomized recruitment of oncologist and their participants-caregivers dyads is feasible to improve communication and illness understanding in participants with advanced cancer and their caregivers. This study will be recruit oncologists first and randomize them to either control of intervention group. Participants and caregivers of the respective oncologists will be recruited and then assigned the same group.
The intervention group, a study team member will be meet with the caregiver for about one hour to review "Our Cancer Care" booklet and help the participant form questions that can be asked at the visit with the oncologist. This will be conducted in person or via secure video-conferencing program. There will be three follow up sessions where the study team member will ask the participants reflection of the prior conversation and the participants conversation with the oncologist and help formulate further questions or clarifications. These sessions should last about 20 minutes.
If assigned to the control group, the participant will receive "Our Cancer Care" booklet.
All participants participating in this study will, irrespective of the group assigned, will be asked to complete surveys about illness and the relationship with the oncology team at appropriate times during the study. A brief questionnaire about the understanding of the illness before and after receiving either the intervention or the booklet.
The time in the study is about one hour to complete each of the two set of surveys through an interview with the research staff, about five minutes to rate your illness understanding, and a total of about two hours for the four coaching sessions over a period lasting up to about ten weeks.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant of an oncologist participating in this study
- •Received a diagnosis of hematologic cancer with disease progression following second-line treatment, OR a diagnosis of stage IV gastrointestinal, genitourinary, gynecologic, skin/soft tissue or thoracic/head and neck cancer
- •Fluent in English or Spanish and prefer speaking English or Spanish when talking about health care
- •21 years or older;
- •Have a primary informal caregiver (as defined by an unpaid individual who provides you with emotional, physical, and/or practical support) who is willing and able to participate in the study
- •Able to communicate over the phone with the study team staff
- •Willing to be audio-recorded for study-related communication
排除标准
- •Test result on mental status do not meet the requirement for this study
- •Receiving hospice care now
结局指标
主要结局
Multiple-choice questions will measure fidelity
时间窗: Two years
Treatment fidelity will also be measured
Open-ended, Likert scale will measure fidelity
时间窗: Two years
Treatment fidelity will also be measured
次要结局
- Coding a recording as a group(2 years)
研究者
Biren Saraiya, MD
Assistant Professor of Medicine
Rutgers, The State University of New Jersey