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Meaning-Centered Psychotherapy for Addressing Existential Distress of Patient/Caregiver Dyads Following Hematopoietic Stem Cell Transplantation: Feasibility and Acceptability

2026年8月10日 更新者：Natalie S. McAndrew, PhD, RN、Mayo Clinic
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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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
行为的：Meaning-Centered Psychotherapy
Survivor and caregiver dyads will participate in a seven-session, telehealth delivered Meaning-Centered Psychotherapy for Dyads (MCP-Dyad) program post-transplant.
有源比较器：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.
行为的：Usual Care
Survivor and caregiver dyads will receive standard resources and consultations for hematopoietic stem cell transplantation (HSCT) care, which include a joint educational class for patients and caregivers before and after treatment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM)
大体时间：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.
End of treatment (approximately 14 weeks)
Feasibility to accrue HSCT patient/caregiver dyads
大体时间：2 years
Percentage of eligible caregivers approached who consent and enroll within 24 months.
2 years
MCP-Dyad intervention completion
大体时间：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%).
End of treatment (approximately 14 weeks)
MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM)
大体时间：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.
End of treatment (approximately 14 weeks)
MCP-Dyad retention
大体时间：End of treatment (approximately 14 weeks)
Percentage of randomized dyads with both members completing follow-up assessments (benchmark: 75%).
End of treatment (approximately 14 weeks)
MCP-Dyad intervention fidelity and protocol delivery
大体时间：End of treatment (approximately 14 weeks)
Percentage of audited sessions meeting intervention fidelity standards and delivered per protocol based on fidelity assessments (benchmark: ≥80%)
End of treatment (approximately 14 weeks)
MCP-Dyad appropriateness as rated on the Intervention Appropriateness Measure (IAM)
大体时间：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.
End of treatment (approximately 14 weeks)
MCP-Dyad dyad-level retention outreach
大体时间：End of treatment (approximately 14 weeks)
Percentage of missed sessions or assessments that receive outreach within 2 days (benchmark: ≥85%).
End of treatment (approximately 14 weeks)

次要结果测量

结果测量
措施说明
大体时间
Change in Benefit Finding Scale (BFS) score
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad on benefit finding will be measured using a slightly modified version of the Benefit Finding Scale (BFS), a 17-item measure that captures positive life challenges resulting from adversity (e.g., personal priorities, acceptance, daily activities, family, world views, relationship, purpose). Higher scores indicate greater benefit finding.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in Communal Coping Domains score
大体时间：8 weeks post-intervention
The Communal Coping Domains instrument assesses how patients and caregivers manage health-related behavior change, particularly in the context of health threats by measuring shared perceptions, confidence, and behaviors. There are three tailored subscales: use of communal coping (how frequently dyads use joint efforts to manage health threats), how confident the dyad is in working together to manage health, and beliefs about communal coping strategies. Responses for the use of the communal coping domain range from 1(never) to 5 (very often), and responses for the couple efficacy and outcome efficacy range from 0 (not at all) to 10 (very much). Higher overall scores indicate greater confidence in patient/caregiver coping strategies.
8 weeks post-intervention
Change in survivor and caregiver health-related quality of life.
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad on patient and caregiver health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy -Bone Marrow Transplant (FACT-BMT). The patient instrument is a multidimensional measure of quality of life in adult HSCT patients. Each item is rated from 0 (not at all) to 4 (very much) and is an assessment of symptoms over the past 7 days. Domains include social and family well-being, emotional well-being, functional well-being, and BMT-specific concerns. Higher scores overall indicate better quality of life.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver existential distress
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad on the patient and caregiver's meaning and purpose (increased meaning and purpose equivalent to less existential distress) will be measured using the 48-item Life Attitude Profile-Revised (LAP-R) instrument. It has six domains (purpose, coherence, life control, death acceptance, existential vacuum, goal seeking) that make up two subscales, the Personal Meaning Index and Existential Transcendence. Higher scores generally indicate a more positive attitude towards life.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver spiritual well-being
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad on the patient's and caregiver's spiritual well-being will be measured using the Functional Assessment of Chronic Illness Therapy Spiritual Well-being (FACIT-Sp) Scale. It has two subscales, one for faith and another for meaning/peace. Higher scores indicate greater spiritual well-being.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver mutuality (quality of relationship)
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad on survivor and caregiver mutuality will be measured using Mutuality Scale (MS). The Mutuality Scale measures the positive quality of the relationship between the care recipient and the caregiver. Grounded in the concept of mutuality (degree of love, reciprocity, shared pleasurable activities, and shared values) in the patient/caregiver relationship. There is a four-domain structure with items rated from 0 (not at all) to 4 (a great deal) with question stems examining varies aspects of the relationship (e.g., how much do you enjoy spending time together). Higher overall scores indicate greater mutuality.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in dyadic adjustment (couples only)
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad in couples will be measured using the Revised Dyadic Adjustment Scale (RDAS). The RDAS is a self-report measure of relationship quality in couples. It assesses dyadic consensus, dyadic satisfaction, and dyadic cohesion to give an overall index of marital quality. The rating scale is 0 (always disagree) to 5 (always agree). Higher overall scores indicates greater relationship satisfaction.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in illness-related communication
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The change in illness-related communication will be measured using the Social Constraints Scale. This scale measures the extent to which individuals perceive their social environment, particularly close relationships, as a limiting or discouraging their ability to express thoughts and feelings related to a stressful experience. Items are rated from 1(never) to 4 (very often). Higher scores are equivalent to more social constraints in the relationship.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver needs/distress
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad on the survivor and caregiver's needs/distress will be measured using the Cancer SupportSource Survivors: CCS-15+ and the CancerSupportSource-Caregiver: CCS-Caregiver-18+ instruments. Survivors and caregivers will rate their level of concern from 0 (not at all) to 4 (very serious concern). Questions for survivors focus on emotional well-being, symptom burden & impact, body image & healthy lifestyle, health care team communication, relationships & intimacy. Questions for caregivers focus on 5 areas of concern (emotional well-being, survivor well-being, caregiving tasks, finances, and healthy lifestyle) and areas of desired support. A total score for distress is recommended based on 18 items.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver psychological distress
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The impact of MCP-Dyad on psychological distress will be measured using 2 anxiety and 2 depression questions from the CCS-15+ and the CCS-Caregiver-18+. These questions have established clinical cut offs. Scores range from 0 to 8. Survivor scores of 3 or above signify clinically significant anxiety or depression. Caregiver anxiety scores of 4 and above, and depression scores of 3 or above, indicate clinically significant distress.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in Dyadic Relationship Scale score
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The Dyadic Relationship Scale is a brief dyadic measure assessing positive dyadic interaction and negative dyadic strain from both caregiver and care recipient perspectives. The caregiver version includes 11 items and the care recipient version includes 10 items, with two subscales: positive dyadic interaction and negative dyadic strain.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in interdependence of survivor and caregiver
大体时间：Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
The Inclusion of Other in the Self Scale is a single-item pictorial measure of perceived relationship closeness and self-other overlap. Respondents select one of seven increasingly overlapping circle pairs to represent their relationship with a specified other person, with higher scores indicating greater perceived closeness.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mayo Clinic

调查人员

  • 首席研究员：Natalie McAndrew, PhD, RN、Mayo Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2028年2月28日

研究完成 (估计的)

2028年4月30日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 26-005192

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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