Feasibility and Preliminary Efficacy of a Digital Story Intervention to Facilitate Decision-Making in Patients With Myeloid Cancers Considering Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of Participants Retained (Feasibility - Retention Rate)
研究概览
简要总结
This is a two-arm pilot randomized trial that assesses the feasibility and preliminary efficacy of a digital story and values clarification intervention (Considering alloHCT: Opportunities for Patient Reflection During Decision-Making via Digital Stories [CHORDS]) compared to usual care among patients with myeloid cancers considering allogeneic hematopoietic cell transplantation (alloHCT).
详细描述
Our proposed intervention is Considering alloHCT: Opportunities for Patient Reflection During Decision-Making via Digital Stories (CHORDS), which includes: 1) real-life digital stories of individuals with similar experiences who previously underwent consultation for allogeneic hematopoietic cell transplantation and their caregivers and 2) explicit values clarification exercises designed to help patients reflect on their emotions and clarify what matters to them, including a) an interactive workbook, and b) best-worst scaling. Together, they help patients reflect on their values and prioritize their own needs and goals, enhance emotional awareness, and gain experiential knowledge from peers to better understand the real-life implications of treatment risks and benefits.
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
- •Inclusion criteria:
- •Age >21 years old
- •Diagnosis of myeloid cancer (e.g. AML, MDS, myelofibrosis, CML, or MDS/MPN)
- •Being considered for alloHCT
- •Able to provide informed consent
- •Able to speak English. The reason for this is because the digital stories have been created in the English language and their multimedia form cannot easily be translated.
排除标准
- •Patients with psychiatric or cognitive conditions which the hematologist believes prohibits informed consent or compliance with study procedures
- •Inclusion criteria:
- •Age >18 years old
- •Selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters."
- •Caregiver may be paid/professional or informal caregiver
- •Able to provide informed consent
- •Able to speak English
- •Exclusion Criteria:
- •Hematologists
- •Inclusion criteria:
- •1) Hematologists of the patients who agree to enroll on the study who are part of WCI.
- •Exclusion criteria
研究组 & 干预措施
Usual Care
Patients randomized to the usual care arm will receive standard of care. Patients (and their caregivers when available) randomized to usual care will not participate in CHORDS. Patients and caregivers will complete baseline (T1) and post-alloHCT office visit (T3, T4, T5) assessments.
Intervention (CHORDS)
The CHORDS intervention consists of 1) digital stories created by individuals who previously underwent consultation for alloHCT and 2) explicit values clarification exercises designed to help patients reflect on their emotions and clarify what matters to them, including a) an interactive workbook, and b) best-worst scaling (BWS).
干预措施: CHORDS (Other)
结局指标
主要结局
Percentage of Participants Retained (Feasibility - Retention Rate)
时间窗: From enrollment (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
Feasibility will be assessed based on the percentage of enrolled participants who complete both the intervention and post-intervention secondary outcome assessments. The number of participants who complete all study procedures will be divided by the total number enrolled to calculate the retention rate. Higher percentages indicate greater feasibility.
次要结局
- Mean Change in Decisional Engagement Scale Score(Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19))
- Mean Change in Decisional Conflict Scale Score(Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19))
- Mean Change in Distress Thermometer Score(Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19))
研究者
Rachel Rodenbach
Assistant Professor - Department of Medicine, Hematology/Oncology (SMD)
University of Rochester