LymphomaNCT05274763

Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant

A study testing Quality-of-Life Assessment, Questionnaire Administration and Spiritual Therapy in people with Lymphoma and Plasma Cell Myeloma, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lymphoma, Plasma Cell Myeloma
What is being tested?: Quality-of-Life Assessment, Questionnaire Administration and Spiritual Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 21 Mar 2022to 25 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
PATIENT: Neurologic or cognitive problems that preclude chaplain-delivered Compassion Centered Spiritual Health (CCSH)

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: A Feasibility Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation

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.

Read the detailed description

PRIMARY OBJECTIVE:

To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered Compassion Centered Spiritual Health (CCSH).

OUTLINE:

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

Conditions: Lymphoma, Plasma Cell Myeloma
Being tested: Quality-of-Life Assessment, Questionnaire Administration, Spiritual Therapy
Medical subject headings: Lymphoma, Multiple Myeloma

What participants receive

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

Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Spiritual TherapyProcedure or surgery
Deliver or undergo Compassion Centered Spiritual Health (CCSH) session

Study groups in NCT05274763
Study group	Role	What they receive
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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Spiritual Therapy

What is being measured

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

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.
Measured: 3 months

Secondary outcomes (3)

Number of Sessions Completed
Adherence will be evaluated as the percent of sessions completed by patients and characterized as "low" (< 70%), "moderate" (70-80%),"high" (> 80%) adherence.
Measured: Up to 3 months
Percentage of Cognitive Based Compassion Training
Dosage is quantified as the amount (percentage) of cognitive based compassion training (CBCT) that patients receive. Characterize the modal number of sessions received as well as the range of sessions completed by all patients. From the range, sessions will be categorized of "low" (<70%), "moderate" (70-80%),"high" (> 80%) dosage.
Measured: Up to 3 months
Responsiveness
Evaluate the rate of responsiveness in each session, operationalized as "maximally," "moderately", or "minimally" enthusiastic and attentive during each.
Measured: Up to 3 months

Timeline

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

21 Mar 202225 May 2022

First posted10 Mar 2022
Study start21 Mar 2022
Primary completion25 May 2022
Study completion25 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LymphomaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05274763
Sponsor's protocol ID: STUDY00003563
Other IDs: NCI-2022-00233, STUDY00003563, EU5492-21, K01AT010488, P30CA138292
Status last verified: Mar 2024
First submitted: 25 Feb 2022
Last updated: 16 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

All Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05274763
Acronym / sponsor ID: STUDY00003563
Conditions: Lymphoma, Plasma Cell Myeloma
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
Study start: 21 Mar 2022 (actual)
Primary completion: 25 May 2022 (actual)
Study completion: 25 May 2022 (actual)
First posted: 10 Mar 2022 (actual)
Results: Posted 16 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered Compassion Centered Spiritual Health (CCSH).

OUTLINE:

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

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Supportive Care	Experimental	Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Spiritual TherapyPatients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
PATIENT: Neurologic or cognitive problems that preclude chaplain-delivered Compassion Centered Spiritual Health (CCSH)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Supportive Care
Questionnaire AdministrationAncillary studies	Other	Supportive Care
Spiritual TherapyDeliver or undergo Compassion Centered Spiritual Health (CCSH) session	Procedure or surgery	Supportive Care

Primary outcome

Fidelity to Intervention Delivery
Time frame: 3 months
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 secondary outcomes

Number of Sessions Completed
Time frame: Up to 3 months
Percentage of Cognitive Based Compassion Training
Time frame: Up to 3 months
Responsiveness
Time frame: Up to 3 months

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supportive Care: Compassion Centered Spiritual Health (CCSH)	30	29

Primary outcome: Fidelity to Intervention Delivery

Time frame: 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Supportive Care: Compassion Centered Spiritual Health (CCSH) n = 30
Value	19.9 (4.84)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supportive Care (CCSH)	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): This study was not designed to evaluate efficacy, therefore no statistical analysis was developed or associated with this trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Lymphoma

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Mascaro, PhD principal investigator

Emory University Hospital/Winship Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Quality-of-Life Assessment, Questionnaire Administration and Spiritual Therapy in people with Lymphoma and Plasma Cell Myeloma, run by Emory University 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2024. 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?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fidelity to Intervention Delivery (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05274763.

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 16 Apr 2024.