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

10 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Conductual: 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.
Comparador activo: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM)
Periodo de tiempo: 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
Periodo de tiempo: 2 years
Percentage of eligible caregivers approached who consent and enroll within 24 months.
2 years
MCP-Dyad intervention completion
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Benefit Finding Scale (BFS) score
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mayo Clinic

Investigadores

  • Investigador principal: Natalie McAndrew, PhD, RN, Mayo Clinic

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de diciembre de 2026

Finalización primaria (Estimado)

28 de febrero de 2028

Finalización del estudio (Estimado)

30 de abril de 2028

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2026

Publicado por primera vez (Actual)

19 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 26-005192

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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