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

10 augustus 2026 bijgewerkt door: Natalie S. McAndrew, PhD, RN, Mayo Clinic
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Meaning-Centered Psychotherapy (MCP) Dyad
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
Gedragsmatig: 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.
Actieve vergelijker: Usual Care
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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM)
Tijdsspanne: 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.
End of treatment (approximately 14 weeks)
Feasibility to accrue HSCT patient/caregiver dyads
Tijdsspanne: 2 years
Percentage of eligible caregivers approached who consent and enroll within 24 months.
2 years
MCP-Dyad intervention completion
Tijdsspanne: 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%).
End of treatment (approximately 14 weeks)
MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM)
Tijdsspanne: 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.
End of treatment (approximately 14 weeks)
MCP-Dyad retention
Tijdsspanne: End of treatment (approximately 14 weeks)
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
Tijdsspanne: End of treatment (approximately 14 weeks)
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 appropriateness as rated on the Intervention Appropriateness Measure (IAM)
Tijdsspanne: 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.
End of treatment (approximately 14 weeks)
MCP-Dyad dyad-level retention outreach
Tijdsspanne: End of treatment (approximately 14 weeks)
Percentage of missed sessions or assessments that receive outreach within 2 days (benchmark: ≥85%).
End of treatment (approximately 14 weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Benefit Finding Scale (BFS) score
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in Communal Coping Domains score
Tijdsspanne: 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.
8 weeks post-intervention
Change in survivor and caregiver health-related quality of life.
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver existential distress
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver spiritual well-being
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver mutuality (quality of relationship)
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in dyadic adjustment (couples only)
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in illness-related communication
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver needs/distress
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in survivor and caregiver psychological distress
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in Dyadic Relationship Scale score
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
Change in interdependence of survivor and caregiver
Tijdsspanne: 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.
Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mayo Clinic

Onderzoekers

  • Hoofdonderzoeker: Natalie McAndrew, PhD, RN, Mayo Clinic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

28 februari 2028

Studie voltooiing (Geschat)

30 april 2028

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

10 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 26-005192

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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