Empowerment Through Preparedness: Improving Advance Care Planning (ACP) in Adolescents and Young Adults (AYAs) With Advanced Solid Malignancies and High-Grade Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of implementing routine, early Advance Care Planning (ACP)
研究概览
简要总结
This clinical trial studies whether educational tools work to improve early advance care planning (ACP) in adolescents and young adults (AYAs) with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and high-grade brain tumors. The incidence of AYA cancers is on the rise with approximately 90,000 new diagnoses yearly in the United States. Cancer remains the leading cause of disease-related death among AYAs, which could be due to patients having more advanced disease at presentation. It is recommended that AYAs begin ACP conversations at the start of treatment. ACP includes clarifying goals of care, discussions about end-of-life preferences, and completing a legal document that states the treatment or care a person wishes to receive or not receive if they become unable to make medical decisions (advance directive). The educational tools in this study include an early ACP educational video featuring AYAs with cancer and an ACP appointment geared for AYAs. Patients can access and watch the educational video at home prior to their scheduled ACP appointment. During the ACP appointment, a tailored ACP guide made specifically for AYAs is reviewed and questions regarding ACP are answered. This may help to introduce the importance of key ACP concepts, which may improve early ACP in AYAs with advanced solid tumors and high-grade brain tumors.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-39 at initial cancer diagnosis
- •Patient <18 years of age are not included in this pilot as Mayo Clinic in Arizona (MCA) does not treat pediatric patients
- •Recently diagnosed (defined as 12 months or less from initial diagnosis or advance stage relapse) with either a stage III/IV solid malignancy or high-grade brain tumor. This includes patients who have stage III/IV recurrence of previously stage I/II solid malignancy
- •Actively receiving primary oncologic care at Mayo Clinic Arizona
- •Able to read, understand, and speak English
- •Those who have completed prior advanced directive documents are still eligible to participate.
排除标准
- •Age < 18 or > 39 at initial cancer diagnosis
- •Diagnosed with stage I/II solid malignancy, low-grade brain tumor, or hematologic malignancy
- •Not receiving primary oncologic care at Mayo Clinic Arizona
- •Unable to read, understand, and speak English
- •Patients > 12 months from initial diagnosis or advanced stage relapses, in survivorship or on hospice
- •No internet or computer/smart phone access
研究组 & 干预措施
Supportive care (early ACP)
Patients watch a brief, on-demand early ACP educational video at baseline and then one month later attend an ACP appointment with either an AYA social worker or AYA palliative medicine physician assistant over 1 hour.
干预措施: Advance Care Planning (Behavioral)
Supportive care (early ACP)
Patients watch a brief, on-demand early ACP educational video at baseline and then one month later attend an ACP appointment with either an AYA social worker or AYA palliative medicine physician assistant over 1 hour.
干预措施: Educational Intervention (Other)
Supportive care (early ACP)
Patients watch a brief, on-demand early ACP educational video at baseline and then one month later attend an ACP appointment with either an AYA social worker or AYA palliative medicine physician assistant over 1 hour.
干预措施: Electronic Health Record Review (Other)
Supportive care (early ACP)
Patients watch a brief, on-demand early ACP educational video at baseline and then one month later attend an ACP appointment with either an AYA social worker or AYA palliative medicine physician assistant over 1 hour.
干预措施: Survey Administration (Other)
结局指标
主要结局
Feasibility of implementing routine, early Advance Care Planning (ACP)
时间窗: Up to 1 year
Feasibility is achieved if 60% of participants can complete the baseline survey, view the pre-appointment educational video, and attend the hour-long ACP appointment. Baseline survey completion will be defined as answering at least 80% of the survey questions. Video viewing will be assessed via a single yes/no survey item presented after the video. Results will be analyzed descriptively.
Satisfaction with each intervention component (Acceptability)
时间窗: Up to 1 year
Acceptability is defined as majority satisfaction with each intervention component. Participants will be asked to rate their experience with the educational ACP video and ACP appointment on a 4-point Likert scale (e.g., very helpful, somewhat helpful, a little helpful, not helpful) using 4 questions regarding each intervention's usefulness and recommendations to peers. Higher scores indicate greater satisfaction and/or greater likelihood of recommending to peers. Descriptive statistics will be utilized to broadly analyze the sample.
Feasibility of implementing routine, early Advance Care Planning (ACP)
时间窗: Up to 1 year
Feasibility is achieved if 60% of participants can complete the baseline survey, view the pre-appointment educational video, and attend the hour-long ACP appointment. Baseline survey completion will be defined as answering at least 80% of the survey questions. Video viewing will be assessed via a single yes/no survey item presented after the video. Results will be analyzed descriptively.
Satisfaction with each intervention component (Acceptability)
时间窗: Up to 1 year
Acceptability is defined as majority satisfaction with each intervention component. Participants will be asked to rate their experience with the educational ACP video and ACP appointment on a 4-point Likert scale (e.g., very helpful, somewhat helpful, a little helpful, not helpful) using 4 questions regarding each intervention's usefulness and recommendations to peers. Higher scores indicate greater satisfaction and/or greater likelihood of recommending to peers. Descriptive statistics will be utilized to broadly analyze the sample.
次要结局
- Advance directive completion rates(Up to 1 year)
- Change in ACP readiness(Baseline; 4 months; 7 months)
- Change in ACP anxiety(Baseline; 4 months; 7 months)