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Hematopoietic Stem Cell TransplantNCT07595146

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

A study testing Meaning-Centered Psychotherapy in people with Hematopoietic Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematopoietic Stem Cell Transplant
What is being tested?
Meaning-Centered Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

    Study Team, 507-422-5523, rstnursingresearch@mayo.edu

Other trials in United States

About this study

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.

Being tested
Meaning-Centered Psychotherapy, Usual Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meaning-Centered PsychotherapyBehavioural

    Survivor and caregiver dyads will participate in a seven-session, telehealth delivered Meaning-Centered Psychotherapy for Dyads (MCP-Dyad) program post-transplant.

  • Usual CareBehavioural

    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.

Study groups in NCT07595146
Study groupRoleWhat they receive
Meaning-Centered Psychotherapy (MCP) DyadExperimentalThe 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
Receives: Behavioral: Meaning-Centered Psychotherapy
Usual CareActive comparatorThe 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.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility to accrue HSCT patient/caregiver dyads

    Percentage of eligible caregivers approached who consent and enroll within 24 months.

    Measured: 2 years

  2. MCP-Dyad intervention completion

    Percentage of patients and caregivers in the MCP-Dyad cohort who complete at least 5 out of 7 intervention sessions (benchmark: 70%).

    Measured: End of treatment (approximately 14 weeks)

  3. MCP-Dyad Feasibility rating from participants (Feasibility of Intervention Measure-FIM)

    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.

    Measured: End of treatment (approximately 14 weeks)

  4. MCP-Dyad retention

    Percentage of randomized dyads with both members completing follow-up assessments (benchmark: 75%).

    Measured: End of treatment (approximately 14 weeks)

  5. MCP-Dyad intervention fidelity and protocol delivery

    Percentage of audited sessions meeting intervention fidelity standards and delivered per protocol based on fidelity assessments (benchmark: ≥80%)

    Measured: End of treatment (approximately 14 weeks)

  6. 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.

    Measured: End of treatment (approximately 14 weeks)

  7. MCP-Dyad appropriateness as rated on the Intervention Appropriateness Measure (IAM)

    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.

    Measured: End of treatment (approximately 14 weeks)

  8. MCP-Dyad dyad-level retention outreach

    Percentage of missed sessions or assessments that receive outreach within 2 days (benchmark: ≥85%).

    Measured: End of treatment (approximately 14 weeks)

Secondary outcomes (12)
  1. Change in survivor and caregiver health-related quality of life.

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  2. Change in survivor and caregiver existential distress

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  3. Change in survivor and caregiver spiritual well-being

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  4. 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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  5. Change in survivor and caregiver mutuality (quality of relationship)

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  6. Change in dyadic adjustment (couples only)

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  7. Change in illness-related communication

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  8. 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.

    Measured: 8 weeks post-intervention

  9. Change in survivor and caregiver needs/distress

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  10. Change in survivor and caregiver psychological distress

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  11. Change in Dyadic Relationship Scale score

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

  12. Change in interdependence of survivor and caregiver

    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.

    Measured: Baseline, End of treatment (approximately 14 weeks), 8 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07595146
Sponsor's protocol ID
26-005192
Status last verified
Aug 2026
First submitted
12 May 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Meaning-Centered Psychotherapy in people with Hematopoietic Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Team (507-422-5523, rstnursingresearch@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility to accrue HSCT patient/caregiver dyads (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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