Not yet recruiting NCT07595146
Meaning-Centered Psychotherapy for Addressing Existential Distress of Patient/Caregiver Dyads Following Hematopoietic Stem Cell Transplantation: Feasibility and Acceptability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meaning-Centered Psychotherapy, Usual Care.
- Who it may be relevant to
- Registry conditions: Hematopoietic Stem Cell Transplant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Feasibility to accrue HSCT patient/caregiver dyads [Time frame: 2 years]
- MCP-Dyad intervention completion [Time frame: End of treatment (approximately 14 weeks)]
- MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM) [Time frame: End of treatment (approximately 14 weeks)]
- MCP-Dyad retention [Time frame: End of treatment (approximately 14 weeks)]
- MCP-Dyad intervention fidelity and protocol delivery [Time frame: End of treatment (approximately 14 weeks)]
- MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM) [Time frame: End of treatment (approximately 14 weeks)]
- MCP-Dyad appropriateness as rated on the Intervention Appropriateness Measure (IAM) [Time frame: End of treatment (approximately 14 weeks)]
- MCP-Dyad dyad-level retention outreach [Time frame: End of treatment (approximately 14 weeks)]
Secondary outcome measures (12)
- Change in survivor and caregiver health-related quality of life. [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in survivor and caregiver existential distress [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in survivor and caregiver spiritual well-being [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in Benefit Finding Scale (BFS) score [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in survivor and caregiver mutuality (quality of relationship) [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in dyadic adjustment (couples only) [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in illness-related communication [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in Communal Coping Domains score [Time frame: 8 weeks post-intervention]
- Change in survivor and caregiver needs/distress [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in survivor and caregiver psychological distress [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in Dyadic Relationship Scale score [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
- Change in interdependence of survivor and caregiver [Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07595146 · 26-005192