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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Feasibility to accrue HSCT patient/caregiver dyads [Срок оценки: 2 years]
• MCP-Dyad intervention completion [Срок оценки: End of treatment (approximately 14 weeks)]
• MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM) [Срок оценки: End of treatment (approximately 14 weeks)]
• MCP-Dyad retention [Срок оценки: End of treatment (approximately 14 weeks)]
• MCP-Dyad intervention fidelity and protocol delivery [Срок оценки: End of treatment (approximately 14 weeks)]
• MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM) [Срок оценки: End of treatment (approximately 14 weeks)]
• MCP-Dyad appropriateness as rated on the Intervention Appropriateness Measure (IAM) [Срок оценки: End of treatment (approximately 14 weeks)]
• MCP-Dyad dyad-level retention outreach [Срок оценки: End of treatment (approximately 14 weeks)]

Вторичные конечные точки (12)

• Change in survivor and caregiver health-related quality of life. [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in survivor and caregiver existential distress [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in survivor and caregiver spiritual well-being [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in Benefit Finding Scale (BFS) score [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in survivor and caregiver mutuality (quality of relationship) [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in dyadic adjustment (couples only) [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in illness-related communication [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in Communal Coping Domains score [Срок оценки: 8 weeks post-intervention]
• Change in survivor and caregiver needs/distress [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in survivor and caregiver psychological distress [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in Dyadic Relationship Scale score [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
• Change in interdependence of survivor and caregiver [Срок оценки: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT07595146 · 26-005192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗