Improving Goals of Care Conversations With Hematopoietic Cell Transplant Survivors (IMPACT - HCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility (Rate of enrollment)
研究概览
简要总结
This clinical trial evaluates the impact of patient navigation and the Planning Advance Care Together (PACT) website, either alone or in combination with one another, on advanced care planning (ACP) in patients with blood cancers who received a hematopoietic cell transplant (HCT). Engagement in ACP, including having goals of care conversations, improves quality of care at the end of life and supporting this should be included in all cancer survivorship care. Patient navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening follow-up, diagnosis, treatment, and supportive care. PACT is a web-based tool that provides information about ACP, assistance with documents for advanced directives, a supportive network and a forum for discussions about ACP. Patients who engage in ACP are more likely to have higher quality of life at the end of life, receive the care they want, die where they prefer, utilize hospice effectively, and are less likely to receive futile, aggressive care at the end of life. For HCT survivors at ongoing risk of death and other disease-related complications, having a plan in place for care they want is critical. Patient navigation and/or the PACT website may improve ACP, including completion of advance care directives and goals of care conversations, in patients with blood cancers who received an HCT.
详细描述
OUTLINE: Patients are randomized to 1 of 4 conditions.
CONDITION 1 (PACT + PATIENT NAVIGATION): Patients interact with the PACT website over 4 weeks and receive a navigation session over 45-60 minutes with a trained health coach to review ACP.
CONDITION 2 (PATIENT NAVIGATION ONLY): Patients receive a navigation session over 45-60 minutes with a trained health coach to review ACP.
CONDITION 3 (PACT ONLY): Patients interact with the PACT website over 4 weeks.
CONDITION 4 (NO PACT/NO PATIENT NAVIGATION): Patients receive standard/usual care for 4 weeks on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Received a transplant for a hematologic malignancy
- •Current age 18 years of age or older
- •Currently 1 to 5 years after HCT
- •Ability to speak and read English
- •Has not completed all advance directives and/or had a goals of care (GOC) conversation with their physician
- •Access to the internet (via computer, tablet, or mobile device)
排除标准
- •Unable to provide informed consent
- •Uncontrolled psychiatric conditions (confirmed through electronic health record [EHR] by study staff)
研究组 & 干预措施
Condition 4 (standard/usual care)
Patients receive standard/usual care for 4 weeks on study.
干预措施: Survey Administration (Other)
Condition 1 (PACT, patient navigation)
Patients interact with the PACT website over 4 weeks and receive a navigation session over 45-60 minutes with a trained health coach to review ACP.
干预措施: Internet-Based Intervention (Other)
Condition 3 (PACT)
Patients interact with the PACT website over 4 weeks.
干预措施: Survey Administration (Other)
Condition 4 (standard/usual care)
Patients receive standard/usual care for 4 weeks on study.
干预措施: Best Practice (Other)
Condition 3 (PACT)
Patients interact with the PACT website over 4 weeks.
干预措施: Internet-Based Intervention (Other)
Condition 1 (PACT, patient navigation)
Patients interact with the PACT website over 4 weeks and receive a navigation session over 45-60 minutes with a trained health coach to review ACP.
干预措施: Patient Navigation (Behavioral)
Condition 1 (PACT, patient navigation)
Patients interact with the PACT website over 4 weeks and receive a navigation session over 45-60 minutes with a trained health coach to review ACP.
干预措施: Survey Administration (Other)
Condition 2 (patient navigation)
Patients receive a navigation session over 45-60 minutes with a trained health coach to review ACP.
干预措施: Patient Navigation (Behavioral)
Condition 2 (patient navigation)
Patients receive a navigation session over 45-60 minutes with a trained health coach to review ACP.
干预措施: Survey Administration (Other)
结局指标
主要结局
Feasibility (Rate of enrollment)
时间窗: At baseline
Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. Feasibility cutoffs will be based on prior research and include \>= 50% of eligible patients will enroll in the study.
Acceptability of intervention
时间窗: At 4 weeks post intervention
Will be measured using the 4-item Acceptability of Intervention Measure. Items are rated on a 5-point Likert scale. Acceptability will be defined as a median score of \>= 4.
Feasibility (Rate of completion of intervention components)
时间窗: At 12 weeks post intervention
For the patient navigation component, this means that patients participate in the single patient navigation session with a health coach. For the Planning Advance Care Together (PACT) condition, this means that patients set up an account with the PACT website and engage in at least accessing the website. Feasibility cutoffs will be based on prior research and include \>= 50% of enrolled patients will adhere to and complete assigned intervention components and study-related assessments.
Feasibility (Rate of completion of study assessments)
时间窗: At baseline, and at 4 and 12 weeks post intervention
Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. Feasibility cutoffs will be based on prior research and include \>= 50% of enrolled patients will adhere to and complete assigned intervention components and study-related assessments.
Completion of advance directives
时间窗: At baseline, and at 4 and 12 weeks post intervention
Questions asking patients whether they have completed a do not resuscitate (DNR) order, living will or identified a health care proxy. This item is scored as having no advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), investigators will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures.
次要结局
- Engagement with PACT website(At baseline, and at 4 and 12 weeks post intervention)
- Discussion of advance care planning (ACP)/goals of care conversation(At baseline, and at 4 and 12 weeks post intervention)
- Readiness to engage in ACP(At baseline, and at 4 and 12 weeks post intervention)
- Level of engagement in ACP(At baseline, and at 4 and 12 weeks post intervention)
- Self-efficacy for treatment decision-making(At baseline, and at 4 and 12 weeks post intervention)
- Psychological distress(At baseline, and at 4 and 12 weeks post intervention)
- Engagement with patient navigation intervention (Completion rates of patient navigation intervention session)(At 4 weeks post intervention)