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

NCT07595146 | Not Yet Recruiting

• 1 other identifier: 26-005192
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (8)

• Feasibility to accrue HSCT patient/caregiver dyads

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

  2 years

• 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%).

  End of treatment (approximately 14 weeks)

• 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.

  End of treatment (approximately 14 weeks)

• MCP-Dyad retention

  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

  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 acceptability as rated on the Acceptability of Intervention Measure (AIM)

  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)

• MCP-Dyad appropriateness as rated on the Intervention Appropriateness Measure (IAM)

  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

  Percentage of missed sessions or assessments that receive outreach within 2 days (benchmark: ≥85%).

  End of treatment (approximately 14 weeks)

Secondary Outcomes (12)

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

  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 Benefit Finding Scale (BFS) score

  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

Study Arms (2)

Meaning-Centered Psychotherapy (MCP) Dyad

EXPERIMENTAL

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

Behavioral: Meaning-Centered Psychotherapy

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

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.

Meaning-Centered Psychotherapy (MCP) Dyad

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Natalie McAndrew, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

507-422-5523; rstnursingresearch@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)