Meaning-Centered Psychotherapy for Addressing Existential Distress of Patient/Caregiver Dyads Following Hematopoietic Stem Cell Transplantation: Feasibility and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility to accrue HSCT patient/caregiver dyads
研究概览
简要总结
The purpose of this study is to learn whether Meaning-Centered Psychotherapy (MCP-Dyad) is practical, acceptable, and helpful to survivors and caregivers during recovery after stem cell transplant. MCP-Dyad is a meaning-focused support program. It is designed to help people stay connected to meaning, cope with difficult experiences, and communicate as a pair during recovery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients and their caregivers must be adults (≥18 years)
- •Patient must have undergone HSCT for a malignant blood cancer condition
- •Caregiver must be the main support person (e.g., signed caregiving contract) for the HSCT patient
- •Both the patient and their caregiver must be willing to participate in the study (dyads only)
- •Be able to read, write, and speak in English
- •Have access to a smartphone, computer, or tablet necessary for study participation and assessments. If a patient/caregiver dyad is interested in participating but does not have such a device, we will provide a Tracfone with smartphone capabilities for each member of the dyad
排除标准
- •Patients undergoing HSCT for nonmalignant conditions
- •Patients and caregivers with severe cognitive or psychiatric impairment that may affect informed consent/participation
- •Prisoners, pregnant women, and institutionalized persons
- •Patients with severe cognitive or psychiatric impairment that would affect informed consent or participation
研究组 & 干预措施
Meaning-Centered Psychotherapy (MCP) Dyad
The MCP-Dyad arm participants will meet with an MCP-Dyad interventionist to engage in didactic content, reflection, and discussion to teach participants how to apply four sources of meaning to their lives
干预措施: Meaning-Centered Psychotherapy (Behavioral)
Usual Care
The standard of care arm will receive standard resources and consultations for HSCT care, which include a joint educational class for patients and caregivers before and after treatment.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Feasibility to accrue HSCT patient/caregiver dyads
时间窗: 2 years
Percentage of eligible caregivers approached who consent and enroll within 24 months.
MCP-Dyad intervention completion
时间窗: End of treatment (approximately 14 weeks)
Percentage of patients and caregivers in the MCP-Dyad cohort who complete at least 5 out of 7 intervention sessions (benchmark: 70%).
MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM)
时间窗: End of treatment (approximately 14 weeks)
Percentage of patients and caregivers who rate MCP-Dyad as 4/5 or higher on the Feasibility of Intervention Measure (FIM) 4-item questionnaire (benchmark: 70%). Higher scores signify greater agreement with intervention feasibility.
MCP-Dyad retention
时间窗: End of treatment (approximately 14 weeks)
Percentage of randomized dyads with both members completing follow-up assessments (benchmark: 75%).
MCP-Dyad intervention fidelity and protocol delivery
时间窗: End of treatment (approximately 14 weeks)
Percentage of audited sessions meeting intervention fidelity standards and delivered per protocol based on fidelity assessments (benchmark: ≥80%)
MCP-Dyad appropriateness as rated on the Intervention Appropriateness Measure (IAM)
时间窗: End of treatment (approximately 14 weeks)
Percentage of patients and caregivers who rate the intervention as 4/5 or higher on the 4-item Intervention Appropriateness Measure (IAM) questionnaire (benchmark: 70%). Higher scores signify greater agreement with intervention appropriateness.
MCP-Dyad dyad-level retention outreach
时间窗: End of treatment (approximately 14 weeks)
Percentage of missed sessions or assessments that receive outreach within 2 days (benchmark: ≥85%).
MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM)
时间窗: End of treatment (approximately 14 weeks)
Percentage of patients and caregivers who rate the intervention as 4/5 or higher on the 4-item Acceptability of Intervention Measure (AIM) questionnaire (benchmark: 70%). Higher scores signify greater agreement with intervention acceptability.
次要结局
- Change in survivor and caregiver health-related quality of life.(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in interdependence of survivor and caregiver(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in survivor and caregiver existential distress(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in survivor and caregiver spiritual well-being(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in survivor and caregiver mutuality (quality of relationship)(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in dyadic adjustment (couples only)(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in illness-related communication(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in survivor and caregiver needs/distress(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in survivor and caregiver psychological distress(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in Dyadic Relationship Scale score(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in Benefit Finding Scale (BFS) score(Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention)
- Change in Communal Coping Domains score(8 weeks post-intervention)
研究者
Natalie S. McAndrew, PhD, RN
Principal Investigator
Mayo Clinic