An Exploratory Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer and Other Chronic Illnesses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 12
- 主要终点
- Perceived helpfulness
研究概览
简要总结
Background:
- There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful.
Objective:
- To study if Voicing My CHOiCES(TM) can reduce anxiety, improve sense of support, and improve communication about advanced care planning.
Eligibility:
- Adults 18 to 39 years old being treated for cancer.
Design:
- Participants will answer questions about their age, sex, employment, religion, health, and marital status. They will also complete several brief questionnaires:
- General Anxiety Short Form
- Peace, Equanimity and Acceptance in the Cancer Experience
- Functional Assessment of Social Support
- Quality of Communication
- Prior Communication about Advanced Care Planning
- Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations.
- The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.
详细描述
Background:
Discussing end-of-life (EoL) care is very challenging for young adults (YA) living with a life-threatening disease.
While many helpful documents exist to facilitate EoL conversations with adults, few resources exist to aid YA in understanding and accepting their changing physical, emotional and social needs when treatment is no longer effective.
Between 2007-2011, the Pediatric Oncology Branch (07-C-0085) explored the helpfulness of Five Wishes with adolescents and young adults living with HIV or advanced cancer. This research led to the development of a new advance care planning (ACP) guide, Voicing My CHOiCES (VMC). However, Voicing My CHOiCES has not been empirically examined in its completed form.
Objectives:
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
- 否
入选标准
- •ELIGIBILITY CRITERIA FOR PATIENT PARTICIPANTS (COHORT 1A, 1B, 2A, 2B, 3A & 3B):
- •INCLUSION CRITERIA:
- •Patients must be between ages: 18 through 39 years
- •Patients must be diagnosed with cancer or other chronic illness.
- •Patients must give informed consent.
- •Patients must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS; Appendix
- •Patients must be English or Spanish speaking.
- •Cohorts 1B and 2B must be English speaking only.
排除标准
- •Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator or consulting psychiatrist would compromise the patient s ability to engage in the intervention or is likely to interfere with the study procedures or results.
- •Cognitive impairment which in the judgment of the Principal or Associate Investigatorwould compromise the patient s ability to understand the VMC material or is likely to interfere with the study procedures or results.
- •Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the research team would compromise the patient s ability to tolerate or complete this study.
- •Participants who have already completed the Voicing My CHOiCES tool.
- •ELIGIBILITY CRITERIA FOR NON-PATIENT PARTICPANTS (COHORT 4):
- •INCLUSION CRITERIA:
- •Subject must be greater than or equal to 18 years of age
- •Family/friend and/or health care providers must be English or Spanish speaking.
- •Family/friend and health care providers must provide informed consent.
研究组 & 干预措施
Cohort 1B / Comparison Young Adults with Children
Young adults who have children and are 18- 39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site.
Cohort 2B / Comparison Independent Young Adults
Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site.
Cohort 1A / Initial Young Adults with Children
Young adults who have a child(ren) and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE
Cohort 3A / Initial Young Adults No Children, Not Independent
Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE
Cohort 4 / Non-patient participants
Family members, friends, or health care providers of patient participant. COMPLETE
Cohort 3B / Comparison Young Adults No Children, Not Independent
Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site.
Cohort 2A / Initial Independent Young Adults
Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE
结局指标
主要结局
Perceived helpfulness
时间窗: 2 months
To determine whether engaging in advance care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness and/or improved communication about ACP with family, friends and/or health care providers.
Improved outcomes
时间窗: 2 months
To determine whether engaging in advanced care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness, and/or improved communication about ACP with family, friends, and/or health care providers.
Feasability
时间窗: 2 months
To assess the helpfulness of the changes made to the original VMC as compared to the revised VMC document.
次要结局
- Feasibility(2 months)
- Benefit vs burden(2 months)
- Helpfullness vs living & parental status(2 months)