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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility to accrue HSCT patient/caregiver dyads | Percentage of eligible caregivers approached who consent and enroll within 18 months. | 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%). | 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. | End of treatment (approximately 14 weeks) |
| MCP-Dyad Retention | Percentage of patients and caregivers who complete follow-up assessments (benchmark: 75%). | End of treatment (approximately 14 weeks) |
| MCP-Dyad Intervention Adherence | Percentage of recorded sessions that are delivered per protocol (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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | 507-422-5523 | rstnursingresearch@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Natalie McAndrew, PhD, RN | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| 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. |
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| 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. | Baseline, End of treatment (approximately 14 weeks) |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention |