Hematopoietic Stem Cell TransplantNCT03737084

Effects of Compassion Training to Patients Undergoing HSCT on Biological and Psychosocial Parameters

A study testing CBCT Intervention in people with Hematopoietic Stem Cell Transplant, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.

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 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hematopoietic Stem Cell Transplant
What is being tested?: CBCT Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 2 sitesBrazil
Study dates: 3 Apr 2018to 1 Jul 2020
Phase: Interventional
Are there results?: None posted in the registry

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 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

patients referred for HSCT attended at Albert Einstein Hospital, as well as their respective caregivers.

Who cannot join

history of severe psychiatric disorders and neurological diseases.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, São Paulo, 05652901
Hospital Israelita Albert Einstein
São Paulo, 05652901

Other trials in Brazil

About this study

Official title: Effects of the Cognitively-Based Compassion Training (CBCT) Adapted to Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) and Their Caregivers on Biological and Psychosocial Parameters

The hematopoietic stem cell transplant (HSCT) experience is emotionally and physically stressful for cancer patients who undergo this procedure. This study aims to evaluate the effects of Cognitively-Based Compassion Training (CBCT) on depression and anxiety symptoms, levels of resilience, hope and self-compassion in patients undergoing HSCT and their caregivers. As well as assessing the effects of CBCT on clinical conditions in patients and cortical activity and heart rate variability in caregivers.

Read the detailed description

The study hopes to show the positive effects of compassion training in patients and their caregivers.

Overall aim:

This study aims to evaluate the effects of Cognitively-Based Compassion Training (CBCT) on: depression and anxiety symptoms; levels of hope; resilience; mindfulness; self-compassion and quality of life. The study also aims to demonstrate whether CBCT training has any effect on clinical parameters of transplanted patients, as well as whether it has an effect on cortical activity and heart rate variability inpatients and caregivers.

Specific objectives:

Develop an adaptation of the CBCT protocol for hospitalized patients;
To evaluate the effect of CBCT on depressive and anxious symptoms in patients and their caregivers;
To evaluate the effect of CBCT on resilience, quality of life and self-compassion in patients and their caregivers;
Investigating the CBCT training results in altering the cortical activity of patients and caregivers while performing a recall task of recent autobiographical experiences;
Investigate whether CBCT training results in changes in heart rate variability in patients and caregivers;
To investigate whether CBCT training has any effect on patient's levels of symptoms, such as: pain, nausea, insomnia, among others;
To evaluate how correlations between psychosocial factors and biological markers: cortical activity and heart rate variability;
Evaluate perceptions and impressions of patients and caregivers on the protocol.

Conditions: Hematopoietic Stem Cell Transplant
Being tested: CBCT Intervention
Keywords: hematopoietic stem cell transplant, cancer, compassion, meditation, depression, anxiety, heart rate variability, resilience
Medical subject headings: Neoplasms, Depression, Anxiety Disorders

What participants receive

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

CBCT InterventionBehavioural
The training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week.

Study groups in NCT03737084
Study group	Role	What they receive
CBCT Intervention	Experimental	The compassion intervention (CBCT) will be performed during the period of hospitalization, in the hospital room, and will be applied simultaneously to the patient his caregiver. The training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week. Receives: Behavioral: CBCT Intervention
Control group	No intervention	Control group participants will receive standard hospital care. Patients and caregivers of the control group will receive the same CBCT intervention at the end of the study.

What is being measured

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

Change from Baseline Anxiety and Depression symptoms at 1 week after intervention
Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items, 7 for anxiety (HADS-A) and 7 items for depression (HADS-D). The final score ranges from 0 to 21 points in each subscale, the higher the score, the greater the symptoms of anxiety or depression (Zigmond and Snaith, 1983).
Measured: baseline,1 week after intervention
Change from Baseline Resilience level at 1 week after intervention
Resilience Scale (RS). Developed by Wagnild and Young (Wagnild and Young, 1993). Composed of 25 items. The Resilience Scale was applied to measure the degree of resilience. It measures two main factors: 'personal competence' (17 items) and 'acceptance of self and life' (8 items). The response scale ranges from 1 ('totally disagree') to 7 ('totally agree'). The total score ranges from 26 to 175 points. The higher the score the higher the level of resilience.
Measured: baseline; 1 week after intervention.
Change from Baseline Self-Compassion level at 1 week after intervention
Self-Compassion Scale. This is a 26-item scale that measures how one typically acts toward oneself in difficult times. These items were designed to assess how respondents perceive their actions toward themselves in difficult times and are rated using a Likert-type scale anchored from 1 (almost never) to 5 (almost always). The scale ranges from 26 to 130 points. The higher the score the higher the level of Self-Compassion. Developed by Kristin Neff.
Measured: baseline; 1 week after intervention.
Change from Baseline Perceived Stress level at 1 week after intervention
Perceived Stress Scale (PSS). This scale measures the degree to which individuals perceive situations as stressful. Composed of 14 items related to sensation. PSS scores are obtained by reversing the scores on the seven positive items, e.g., 0=4, 1=3, 2=2, etc., and then summing across all 14 items. Items 4, 5, 6, 7, 9, 10, and 13 are the positively stated items. A higher score indicates a higher level of Perceived Stress. The final score ranges from 0 to 56 points. Developed by Luft, 2007.
Measured: baseline; 1 week after intervention.

Timeline

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

3 Apr 20181 Jul 2020

First posted9 Nov 2018
Study start3 Apr 2018
Primary completion3 Apr 2020
Study completion1 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Model description: Intervention group: The compassion intervention (CBCT) will be performed during the period of hospitalization, in the hospital room, and will be applied simultaneously to the patient his caregiver. Control Group: Patients and caregivers in the control group will receive standard hospital care. Patients and caregivers of the control group will receive the same compassion intervention at the end of the study.
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03737084
Sponsor's protocol ID: CEP 2.373.269
Status last verified: May 2019
First submitted: 29 Oct 2018
Last updated: 25 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kozasa EH, Radvany J, Barreiros MA, Leite JR, Amaro E Jr. Preliminary functional magnetic resonance imaging Stroop task results before and after a Zen meditation retreat. Psychiatry Clin Neurosci. 2008 Jun;62(3):366. doi: 10.1111/j.1440-1819.2008.01809.x. No abstract available.
PubMed 18588603
Dodds SE, Pace TW, Bell ML, Fiero M, Negi LT, Raison CL, Weihs KL. Feasibility of Cognitively-Based Compassion Training (CBCT) for breast cancer survivors: a randomized, wait list controlled pilot study. Support Care Cancer. 2015 Dec;23(12):3599-608. doi: 10.1007/s00520-015-2888-1. Epub 2015 Aug 16.
PubMed 26275769

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

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory

All Hematopoietic Stem Cell Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of the Cognitively-Based Compassion Training (CBCT) Adapted to Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) and Their Caregivers on Biological and Psychosocial Parameters
ClinicalTrials.gov ID: NCT03737084
Acronym / sponsor ID: CEP 2.373.269
Conditions: Hematopoietic Stem Cell Transplant
Keywords: hematopoietic stem cell transplant, cancer, compassion, meditation, depression, anxiety, heart rate variability, resilience
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Hospital Israelita Albert EinsteinUniversity, hospital or other
Study start: 3 Apr 2018 (actual)
Primary completion: 3 Apr 2020 (actual)
Study completion: 1 Jul 2020 (actual)
First posted: 9 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

The study hopes to show the positive effects of compassion training in patients and their caregivers.

Overall aim:

Specific objectives:

Develop an adaptation of the CBCT protocol for hospitalized patients;
To evaluate the effect of CBCT on depressive and anxious symptoms in patients and their caregivers;
To evaluate the effect of CBCT on resilience, quality of life and self-compassion in patients and their caregivers;
Investigating the CBCT training results in altering the cortical activity of patients and caregivers while performing a recall task of recent autobiographical experiences;
Investigate whether CBCT training results in changes in heart rate variability in patients and caregivers;
To investigate whether CBCT training has any effect on patient's levels of symptoms, such as: pain, nausea, insomnia, among others;
To evaluate how correlations between psychosocial factors and biological markers: cortical activity and heart rate variability;
Evaluate perceptions and impressions of patients and caregivers on the protocol.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: Intervention group: The compassion intervention (CBCT) will be performed during the period of hospitalization, in the hospital room, and will be applied simultaneously to the patient his caregiver. Control Group: Patients and caregivers in the control group will receive standard hospital care. Patients and caregivers of the control group will receive the same compassion intervention at the end of the study.

Arm	Type	Receives
CBCT Intervention	Experimental	Behavioral: CBCT InterventionThe compassion intervention (CBCT) will be performed during the period of hospitalization, in the hospital room, and will be applied simultaneously to the patient his caregiver. The training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week.
Control group	No intervention	–Control group participants will receive standard hospital care. Patients and caregivers of the control group will receive the same CBCT intervention at the end of the study.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

patients referred for HSCT attended at Albert Einstein Hospital, as well as their respective caregivers.

Key exclusion criteria (1 listed)

history of severe psychiatric disorders and neurological diseases.

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
CBCT InterventionThe training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week.	Behavioural	CBCT Intervention

Primary outcome

Change from Baseline Anxiety and Depression symptoms at 1 week after intervention
Time frame: baseline,1 week after intervention
Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items, 7 for anxiety (HADS-A) and 7 items for depression (HADS-D). The final score ranges from 0 to 21 points in each subscale, the higher the score, the greater the symptoms of anxiety or depression (Zigmond and Snaith, 1983).
Change from Baseline Resilience level at 1 week after intervention
Time frame: baseline; 1 week after intervention.
Resilience Scale (RS). Developed by Wagnild and Young (Wagnild and Young, 1993). Composed of 25 items. The Resilience Scale was applied to measure the degree of resilience. It measures two main factors: 'personal competence' (17 items) and 'acceptance of self and life' (8 items). The response scale ranges from 1 ('totally disagree') to 7 ('totally agree'). The total score ranges from 26 to 175 points. The higher the score the higher the level of resilience.
Change from Baseline Self-Compassion level at 1 week after intervention
Time frame: baseline; 1 week after intervention.
Self-Compassion Scale. This is a 26-item scale that measures how one typically acts toward oneself in difficult times. These items were designed to assess how respondents perceive their actions toward themselves in difficult times and are rated using a Likert-type scale anchored from 1 (almost never) to 5 (almost always). The scale ranges from 26 to 130 points. The higher the score the higher the level of Self-Compassion. Developed by Kristin Neff.
Change from Baseline Perceived Stress level at 1 week after intervention
Time frame: baseline; 1 week after intervention.
Perceived Stress Scale (PSS). This scale measures the degree to which individuals perceive situations as stressful. Composed of 14 items related to sensation. PSS scores are obtained by reversing the scores on the seven positive items, e.g., 0=4, 1=3, 2=2, etc., and then summing across all 14 items. Items 4, 5, 6, 7, 9, 10, and 13 are the positively stated items. A higher score indicates a higher level of Perceived Stress. The final score ranges from 0 to 56 points. Developed by Luft, 2007.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Background: PubMed 18588603Kozasa EH, Radvany J, Barreiros MA, Leite JR, Amaro E Jr. Preliminary functional magnetic resonance imaging Stroop task results before and after a Zen meditation retreat. Psychiatry Clin Neurosci. 2008 Jun;62(3):366. doi: 10.1111/j.1440-1819.2008.01809.x. No abstract available.
Background: PubMed 26275769Dodds SE, Pace TW, Bell ML, Fiero M, Negi LT, Raison CL, Weihs KL. Feasibility of Cognitively-Based Compassion Training (CBCT) for breast cancer survivors: a randomized, wait list controlled pilot study. Support Care Cancer. 2015 Dec;23(12):3599-608. doi: 10.1007/s00520-015-2888-1. Epub 2015 Aug 16.

Related trials for Hematopoietic Stem Cell Transplant

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory

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.

Elisa Kozasa, PhD principal investigator

Instituto Israelita de Ensino e Pesquisa Albert Einstein

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

Questions about this trial

What is this clinical trial studying?

A study testing CBCT Intervention in people with Hematopoietic Stem Cell Transplant, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.

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 1 inclusion and 1 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline Anxiety and Depression symptoms at 1 week after intervention (time frame: baseline,1 week after intervention). The study lists 4 primary outcomes in all. 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 NCT03737084, which also lists 2 linked publications.

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 25 Sep 2020.