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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Survivor and caregiver dyads will participate in a seven-session, telehealth delivered Meaning-Centered Psychotherapy for Dyads (MCP-Dyad) program post-transplant.
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.
Mayo Clinic
Rochester, Minnesota, United States
Feasibility to accrue HSCT patient/caregiver dyads
Percentage of eligible caregivers approached who consent and enroll within 18 months.
Time frame: Baseline
Completion of MCP-Dyad
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)
MCP-Dyad Feasibility rating from participants
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)
MCP-Dyad Retention
Percentage of patients and caregivers who complete follow-up assessments (benchmark: 75%).
Time frame: End of treatment (approximately 14 weeks)
MCP-Dyad Intervention Adherence
Percentage of recorded sessions that are delivered per protocol (benchmark: 80%)
Time frame: 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.
Time frame: End of treatment (approximately 14 weeks)
Change in Intervention Appropriateness Measure (IAM) score
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.
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Time frame: Baseline, End of treatment (approximately 14 weeks)
Change in Functional Assessment of Cancer Therapy -Bone Marrow Transplant (FACT-BMT) score
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
Change in Life Attitude Profile-Revised (LAP-R) score
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
Change in Functional Assessment of Chronic Illness Therapy Spiritual Well-being (FACIT-Sp) Scale score
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
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
Change in Mutuality Scale (MS) score
The Mutuality Scale (MS) 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.
Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in Revised Dyadic Adjustment Scale (RDAS) score
The Revised Dyadic Adjustment Scale (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.
Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in Social Constraints Scale score
The Social Constraints 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.
Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in Communal Coping Domains score
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.
Time frame: 8 weeks post-intervention
Percentage of dyads to use plural pronouns (I versus We language)
Communal coping can be objectively measured based on the amount of "we versus I" language across the intervention sessions. Linguistic Inquiry and Word Count (LIWC-22) software is a validated way to examine the number of pronouns uttered. Essentially, this software works by comparing each word in a text against an internal dictionary of words and then provides a percentage of total words that fall into a specific category. We will use the recorded sessions to determine the percentage of subjects using plural pronouns.
Time frame: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention