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

12. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Verhalten: 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.
Aktiver Komparator: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility to accrue HSCT patient/caregiver dyads
Zeitfenster: Baseline
Percentage of eligible caregivers approached who consent and enroll within 18 months.
Baseline
Completion of MCP-Dyad
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: End of treatment (approximately 14 weeks)
Percentage of patients and caregivers who complete follow-up assessments (benchmark: 75%).
End of treatment (approximately 14 weeks)
MCP-Dyad Intervention Adherence
Zeitfenster: End of treatment (approximately 14 weeks)
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)
Zeitfenster: 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)
Change in Intervention Appropriateness Measure (IAM) score
Zeitfenster: Baseline, 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.
Baseline, End of treatment (approximately 14 weeks)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Functional Assessment of Cancer Therapy -Bone Marrow Transplant (FACT-BMT) score
Zeitfenster: 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 Life Attitude Profile-Revised (LAP-R) score
Zeitfenster: 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 Functional Assessment of Chronic Illness Therapy Spiritual Well-being (FACIT-Sp) Scale score
Zeitfenster: 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 Benefit Finding Scale (BFS) score
Zeitfenster: 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 Mutuality Scale (MS) score
Zeitfenster: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
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
Zeitfenster: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
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
Zeitfenster: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
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
Zeitfenster: 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
Percentage of dyads to use plural pronouns (I versus We language)
Zeitfenster: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mayo Clinic

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

28. Februar 2028

Studienabschluss (Geschätzt)

30. April 2028

Studienanmeldedaten

Zuerst eingereicht

12. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 26-005192

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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