NCT05274763

Brief Summary

This clinical trial tests whether chaplain-delivered compassion centered spiritual health (CCSH) works to improve quality of life in patients receiving a stem cell transplant. Compassion Centered Spiritual Health (CCSH) is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling negative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others, Compassion Centered Spiritual Health (CCSH) may help improve response to stress and reduce inflammation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

February 25, 2022

Results QC Date

August 31, 2023

Last Update Submit

March 20, 2024

Conditions

LymphomaPlasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

  • Fidelity to Intervention Delivery

    Chaplains will deliver between four and eight 30-minute sessions (2-4 times per week) to evaluate the fidelity of implementation (FOI). Administer the (4 min) Scottish Patient Reported Outcome Measure. The Patient Reported Outcome Measure is an 18-item Likert-scale that assesses how a hospitalized patient felt about the pastoral care visit both during the consult and after it. The scale will indicate the following range: 5-25, with higher scores indicating more improvement as a result of the chaplain visit and lower scores indicating less improvement as a result of the chaplain visit.

    3 months

Secondary Outcomes (3)

  • Number of Sessions Completed

    Up to 3 months

  • Percentage of Cognitive Based Compassion Training

    Up to 3 months

  • Responsiveness

    Up to 3 months

Study Arms (1)

Supportive Care

EXPERIMENTAL

Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.

Other: Quality-of-Life AssessmentOther: Questionnaire AdministrationProcedure: Spiritual Therapy

Interventions

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Supportive Care
Questionnaire AdministrationOTHER

Ancillary studies

Supportive Care
Spiritual TherapyPROCEDURE

Deliver or undergo Compassion Centered Spiritual Health (CCSH) session

Supportive Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PATIENT: Within 6 weeks of scheduled hematopoietic stem cell transplant (HSCT)
  • PATIENT: \> 18 years of age
  • PATIENT: Speak and read English
  • CHAPLAIN: Emory Healthcare Chaplain

You may not qualify if:

  • PATIENT: Neurologic or cognitive problems that preclude chaplain-delivered Compassion Centered Spiritual Health (CCSH)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

LymphomaMultiple Myeloma

Interventions

Spiritual Therapies

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Limitations and Caveats

This study was not designed to evaluate efficacy, therefore no statistical analysis was developed or associated with this trial.

Results Point of Contact

Title
Dr. Jennifer Mascaro
Organization
Emory University
jmascar@emory.edu
404-727-4301

Study Officials

  • Jennifer Mascaro, PhD

    Emory University Hospital/Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 10, 2022

Study Start

March 21, 2022

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

April 16, 2024

Results First Posted

April 16, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)