Meaning-Centered Psychotherapy for Addressing Existential Distress of Patient/Caregiver Dyads Following Hematopoietic Stem Cell Transplantation: Feasibility and Acceptability
maanantai 10. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
100
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Study Team
- Puhelinnumero: 507-422-5523
- Sähköposti: rstnursingresearch@mayo.edu
Opiskelupaikat
-
-
Minnesota
-
Rochester, Minnesota, Yhdysvallat, 55905
- Mayo Clinic
-
Ottaa yhteyttä:
- Study Team
- Puhelinnumero: 507-422-5523
- Sähköposti: rstnursingresearch@mayo.edu
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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
|
Survivor and caregiver dyads will participate in a seven-session, telehealth delivered Meaning-Centered Psychotherapy for Dyads (MCP-Dyad) program post-transplant.
|
|
Active Comparator: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
MCP-Dyad acceptability as rated on the Acceptability of Intervention Measure (AIM)
Aikaikkuna: 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
Aikaikkuna: 2 years
|
Percentage of eligible caregivers approached who consent and enroll within 24 months.
|
2 years
|
|
MCP-Dyad intervention completion
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Benefit Finding Scale (BFS) score
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Natalie McAndrew, PhD, RN, Mayo Clinic
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Tiistai 1. joulukuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Maanantai 28. helmikuuta 2028
Opintojen valmistuminen (Arvioitu)
Sunnuntai 30. huhtikuuta 2028
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 12. toukokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 12. toukokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Tiistai 19. toukokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 12. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 10. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- 26-005192
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .