Hematopoietic Stem Cell Transplant
Conditions
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.
Interventions
BEHAVIORALMeaning-Centered Psychotherapy
Survivor and caregiver dyads will participate in a seven-session, telehealth delivered Meaning-Centered Psychotherapy for Dyads (MCP-Dyad) program post-transplant.
BEHAVIORALUsual 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility to accrue HSCT patient/caregiver dyads | 2 years | Percentage of eligible caregivers approached who consent and enroll within 24 months. |
| MCP-Dyad intervention completion | End of treatment (approximately 14 weeks) | Percentage of patients and caregivers in the MCP-Dyad cohort who complete at least 5 out of 7 intervention sessions (benchmark: 70%). |
| MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM) | End of treatment (approximately 14 weeks) | 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. |
| MCP-Dyad retention | End of treatment (approximately 14 weeks) | Percentage of randomized dyads with both members completing follow-up assessments (benchmark: 75%). |
| MCP-Dyad intervention fidelity and protocol delivery | End of treatment (approximately 14 weeks) | Percentage of audited sessions meeting intervention fidelity standards and delivered per protocol based on fidelity assessments (benchmark: ≥80%) |
| MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM) | End of treatment (approximately 14 weeks) | 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. |
| MCP-Dyad appropriateness as rated on the Intervention Appropriateness Measure (IAM) | End of treatment (approximately 14 weeks) | 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. |
| MCP-Dyad dyad-level retention outreach | End of treatment (approximately 14 weeks) | Percentage of missed sessions or assessments that receive outreach within 2 days (benchmark: ≥85%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in survivor and caregiver needs/distress | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | The impact of MCP-Dyad on the survivor and caregiver's needs/distress will be measured using the Cancer SupportSource Survivors: CCS-15+ and the CancerSupportSource-Caregiver: CCS-Caregiver-18+ instruments. Survivors and caregivers will rate their level of concern from 0 (not at all) to 4 (very serious concern). Questions for survivors focus on emotional well-being, symptom burden \& impact, body image \& healthy lifestyle, health care team communication, relationships \& intimacy. Questions for caregivers focus on 5 areas of concern (emotional well-being, survivor well-being, caregiving tasks, finances, and healthy lifestyle) and areas of desired support. A total score for distress is recommended based on 18 items. |
| Change in survivor and caregiver psychological distress | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | The impact of MCP-Dyad on psychological distress will be measured using 2 anxiety and 2 depression questions from the CCS-15+ and the CCS-Caregiver-18+. These questions have established clinical cut offs. Scores range from 0 to 8. Survivor scores of 3 or above signify clinically significant anxiety or depression. Caregiver anxiety scores of 4 and above, and depression scores of 3 or above, indicate clinically significant distress. |
| Change in Dyadic Relationship Scale score | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | The Dyadic Relationship Scale is a brief dyadic measure assessing positive dyadic interaction and negative dyadic strain from both caregiver and care recipient perspectives. The caregiver version includes 11 items and the care recipient version includes 10 items, with two subscales: positive dyadic interaction and negative dyadic strain. |
| Change in survivor and caregiver mutuality (quality of relationship) | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | The impact of MCP-Dyad on survivor and caregiver mutuality will be measured using Mutuality Scale (MS). The Mutuality Scale 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. |
| Change in interdependence of survivor and caregiver | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | The Inclusion of Other in the Self Scale is a single-item pictorial measure of perceived relationship closeness and self-other overlap. Respondents select one of seven increasingly overlapping circle pairs to represent their relationship with a specified other person, with higher scores indicating greater perceived closeness. |
| Change in dyadic adjustment (couples only) | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | The impact of MCP-Dyad in couples will be measured using the Revised Dyadic Adjustment Scale (RDAS). The 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. |
| Change in illness-related communication | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | The change in illness-related communication will be measured using the Social Constraints Scale. This 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. |
| Change in Communal Coping Domains score | 8 weeks post-intervention | 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. |
| Change in survivor and caregiver health-related quality of life. | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | 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. |
| Change in survivor and caregiver existential distress | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | 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. |
| Change in survivor and caregiver spiritual well-being | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | 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. |
| Change in Benefit Finding Scale (BFS) score | Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention | 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. |
Countries
United States
Contacts
CONTACTStudy Team
PRINCIPAL_INVESTIGATORNatalie McAndrew, PhD, RN
Mayo Clinic
Outcome results
None listed