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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meaning-Centered Psychotherapy

    Behavioral

    Survivor and caregiver dyads will participate in a seven-session, telehealth delivered Meaning-Centered Psychotherapy for Dyads (MCP-Dyad) program post-transplant.

  • Usual Care

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Meaning-Centered Psychotherapy (MCP) DyadExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility to accrue HSCT patient/caregiver dyads

Percentage of eligible caregivers approached who consent and enroll within 24 months.

Time frame
2 years
2

MCP-Dyad intervention completion

Percentage of patients and caregivers in the MCP-Dyad cohort who complete at least 5 out of 7 intervention sessions (benchmark: 70%).

Time frame
End of treatment (approximately 14 weeks)
3

MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM)

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.

Time frame
End of treatment (approximately 14 weeks)
4

MCP-Dyad retention

Percentage of randomized dyads with both members completing follow-up assessments (benchmark: 75%).

Time frame
End of treatment (approximately 14 weeks)

Secondary outcomes

1

Change in survivor and caregiver health-related quality of life.

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.

Time frame
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
2

Change in survivor and caregiver existential distress

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.

Time frame
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
3

Change in survivor and caregiver spiritual well-being

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.

Time frame
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
4

Change in Benefit Finding Scale (BFS) score

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.

Time frame
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

Other outcomes

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