NCT03737084

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 3, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 25, 2020

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

October 29, 2018

Last Update Submit

September 24, 2020

Conditions

Hematopoietic Stem Cell Transplant

Keywords

hematopoietic stem cell transplantcancercompassionmeditationdepressionanxietyheart rate variabilityresilience

Outcome Measures

Primary Outcomes (4)

  • 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).

    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.

    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.

    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.

    baseline; 1 week after intervention.

Other Outcomes (2)

  • Cortical activity

    baseline, 1 week after intervention

  • Heart rate variability (HRV)

    baseline, 1 week after intervention

Study Arms (2)

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.

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.

Interventions

CBCT InterventionBEHAVIORAL

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

CBCT Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • history of severe psychiatric disorders and neurological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, São Paulo, 05652901, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 18588603BACKGROUND

  • 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.

    PMID: 26275769BACKGROUND

MeSH Terms

Conditions

NeoplasmsDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Elisa Kozasa, PhD

    Instituto Israelita de Ensino e Pesquisa Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 9, 2018

Study Start

April 3, 2018

Primary Completion

April 3, 2020

Study Completion

July 1, 2020

Last Updated

September 25, 2020

Record last verified: 2019-05

Locations

BR(2)