Hematopoietic Stem Cell TransplantationYogaNCT06118853

Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT

A study testing yoga or gentle massage plus standard treatment for HSCT in people with Hematopoietic Stem Cell Transplantation and Bone Marrow Transplantation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation
What is being tested?: yoga or gentle massage plus standard treatment for HSCT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteBrazil
Study dates: 21 Nov 2023to 1 Mar 2025
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 18 and above;
Admitted to HIAE, eligible for Bone Marrow Transplantation;
Patients who speak and read the Portuguese language.

Who cannot join

Patients with hearing impairment;
Patients previously diagnosed with psychiatric disorder: schizophrenia.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Maria Ester Azevedo Massola
São Paulo, São Paulo, 05653000

Other trials in Brazil

About this study

Official title: Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation at the Hospital Israelita Albert Einstein

This project aims to observe the impact of yoga and gentle massage practices on symptom management in patients undergoing Hematopoietic Stem Cell Transplantation (HSCT) at the Israelite Albert Einstein Hospital. It is a prospective, open label, randomized clinical study, comparing the practice of yoga or gentle massage combined with standard treatment versus standard treatment alone. Using the Edmonton Symptom Assessment System in 8 sessions, the investigators will analyze the domains of fatigue, pain, nausea, anxiety, and well-being before and after each session. The investigators will also assess Quality of Life - BMT, changes in Religiosity Scale before and after the intervention, and, at the end, Patient Satisfaction and subjective experience through a qualitative questionnaire. The hypothesis is that the practice of yoga and gentle massage combined with standard treatment is superior to standard treatment alone in symptom management in patients undergoing HSCT.

Read the detailed description

Primary Objective: To assess the impact of yoga and/or gentle massage practices plus standard treatment versus standard treatment alone on symptom management in patients undergoing Hematopoietic Stem Cell Transplantation (HSCT), evaluated using the Edmonton Symptom Assessment Scale (ESAS).

Secondary Objectives:

To analyze changes in the Quality-of-Life Scale during HSCT.
To analyze changes in the Religiosity Scale during HSCT.
To analyze the subjective experience of the patient during HSCT.
To analyze patient satisfaction during HSCT. Hypothesis: The practice of yoga or gentle massage combined with standard treatment is superior to standard treatment alone in symptom management in patients undergoing HSCT.

Population: The study will be conducted at the Hospital Israelita Albert Einstein (HIAE), with patients admitted to the Oncology and Hematology Center for Bone Marrow Transplantation. Only after obtaining Informed Consent (IC) from the patient, clinical and sociodemographic variables during hospitalization will be extracted from the institutional electronic medical record database: age, gender, month/year and type of transplant, conditioning intensity, donor type, cell source, and underlying disease.

Inclusion Criteria: Adults aged 18 and above; admitted to HIAE, eligible for Bone Marrow Transplantation; patients who speak and read Portuguese.

Exclusion Criteria: Patients with hearing impairment; patients previously diagnosed with psychiatric disorders: schizophrenia.

Sample Size: The sample will consist of a minimum of 40 patients for this study.

Based on a pilot sample (n = 40) with only one session of yoga or gentle massage, a variation of 1.58 points (SD = 1.58 points) in fatigue improvement was observed. To find a mean difference of at least 1.5 points between the intervention group (yoga or gentle massage plus standard treatment) and the control group (standard treatment alone) in the proposed 8 sessions, with a power of 80% and a confidence level of 95%, the required sample size for the study would be 18 patients in each group. Since, in addition to fatigue, other parameters such as pain, nausea, anxiety, and well-being will also be evaluated, the investigators will use a sample of at least 20 patients per group to account for these parameters as well, totaling at least 40 patients in the study.

Randomization: Randomization will be carried out according to the randomization block generated by the Redcap tool. Therefore, upon agreeing to participate in the protocol, each patient will be entered into Redcap and randomized according to the specified parameters, stratified by age groups: 18 to 40 / 41 to 60 / above 61 years, and by type of transplant: autologous, allogeneic, and umbilical cord.

Conditions: Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation
Being tested: yoga or gentle massage plus standard treatment for HSCT
Keywords: Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation, Integrative Therapies, Yoga, Massage

What participants receive

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

yoga or gentle massage plus standard treatment for HSCTBehavioural
The yoga sessions will be conducted at the patient's bedside, using one or more of the following techniques: gentle stretches (asanas), guided relaxation (savasana), slow and deep diaphragmatic breathing (pranayama), and meditative exercises focusing on natural breathing or visualization of a soothing place (dhyana). From these techniques, the integrative therapist will choose what best suits the patient for each session, based on their psychophysical state and symptoms presented, as there can be many variations during HSCT. Gentle massage is characterized by soft touches using light pressure, primarily using the palm of the hand, with a slow and steady rhythm across the entire body. It can be performed over clothing or even over the bedsheet and blanket.

Study groups in NCT06118853
Study group	Role	What they receive
Group A (control)	No intervention	Standard treatment for HSCT
Group B (intervention)	Experimental	Yoga or gentle massage plus standard treatment for HSCT Receives: Behavioral: yoga or gentle massage plus standard treatment for HSCT

What is being measured

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

Symptom Management: fatigue, pain, nausea, anxiety, and well-being
The Edmonton Symptom Assessment Scale will be administered both before and after each of the 8 sessions in both groups to evaluate pain, fatigue, nausea, anxiety, and well-being. The scale for each domain ranges from 0 to 10, where 0 signifies no symptoms or excellent well-being, and 10 signifies the most severe symptoms or worst possible well-being.
Measured: The sessions will occur at the following time points: Session 1 and 2 - from admission to Day 0 (infusion) / Session 3 and 4: between Day 1 and Day 7 / Session 5 and 6: between Day 8 and Day 14 / Session 7 and 8: between Day 15 and Day 21 or discharge.

Secondary outcomes (4)

Scale of Quality-of-Life
The investigators will use the Functional Assessment Cancer Therapy - Bone Marrow Transplantation scale, which is a quality-of-life questionnaire designed to measure aspects of quality of life related to bone marrow transplantation. The scale ranges from 0, representing the worst possible quality of life or well-being, to 148, indicating the highest quality of life or well-being. This scale has been translated into Portuguese and validated for use in Brazilian patients.
Measured: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Scale of Religiosity
The Duke University Religion Index is a brief instrument for assessing aspects related to religiosity. The scale consists of five items that capture three dimensions of religiosity most related to health outcomes: organizational, non-organizational, and intrinsic religiosity. The score ranges from 1 to 27, with higher scores indicating greater religiosity. The scale has been translated into Portuguese and validated for use in Brazilian patients.
Measured: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Qualitative Report
On Day 21, a Qualitative Report will be presented through RedCap, and patients will be invited to provide a written response to an open question: "How was your experience with Integrative Medicine?"
Measured: Day 21 or at discharge (whichever comes first).
Patient-Reported Experience Measures
Investigators will utilize Patient-Reported Experience Measures with a scale ranging from 1 to 25, where higher scores indicate better patient experience and satisfaction.
Measured: Day 21 or at discharge (whichever comes first).

Timeline

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

21 Nov 20231 Mar 2025

First posted7 Nov 2023
Study start21 Nov 2023
Primary completion30 Dec 2024
Study completion1 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Hematopoietic Stem Cell TransplantationStudies 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: Patients will be randomized into two groups: Group A (control): standard treatment /Group B (intervention): yoga + gentle massage + standard treatment. Group B (intervention) will receive 8 individual integrative practice sessions at the bedside, each lasting 15 to 20 minutes, with 2 sessions per week during the following periods: from admission until D+0 / until D+7 / until D+14 / until D+21 or discharge. The therapist will choose the integrative practices that best suit the patient for each session, based on their psychophysical state and symptoms, as there can be many variations during HSCT. Group A (control) will receive 8 visits from integrative therapists who will remain in the patient's room, able to interact but without offering integrative practices, during the same periods described above. After D+21, these patients will also receive 8 integrative practice sessions at the bedside or in the Integrative Medicine room.
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06118853
Sponsor's protocol ID: 61711022.6.0000.0071
Acronym: Yoga
Status last verified: Nov 2023
First submitted: 24 Oct 2023
Last updated: 20 Mar 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bazinet A, Popradi G. A general practitioner's guide to hematopoietic stem-cell transplantation. Curr Oncol. 2019 Jun;26(3):187-191. doi: 10.3747/co.26.5033. Epub 2019 Jun 1.
PubMed 31285665
Gratwohl A, Baldomero H, Aljurf M, Pasquini MC, Bouzas LF, Yoshimi A, Szer J, Lipton J, Schwendener A, Gratwohl M, Frauendorfer K, Niederwieser D, Horowitz M, Kodera Y; Worldwide Network of Blood and Marrow Transplantation. Hematopoietic stem cell transplantation: a global perspective. JAMA. 2010 Apr 28;303(16):1617-24. doi: 10.1001/jama.2010.491.
PubMed 20424252
Foord AM, Cushing-Haugen KL, Boeckh MJ, Carpenter PA, Flowers MED, Lee SJ, Leisenring WM, Mueller BA, Hill JA, Chow EJ. Late infectious complications in hematopoietic cell transplantation survivors: a population-based study. Blood Adv. 2020 Apr 14;4(7):1232-1241. doi: 10.1182/bloodadvances.2020001470.
PubMed 32227211
Cohen MZ, Rozmus CL, Mendoza TR, Padhye NS, Neumann J, Gning I, Aleman A, Giralt S, Cleeland CS. Symptoms and quality of life in diverse patients undergoing hematopoietic stem cell transplantation. J Pain Symptom Manage. 2012 Aug;44(2):168-80. doi: 10.1016/j.jpainsymman.2011.08.011. Epub 2012 Jun 13.
PubMed 22699091
Deng G. Integrative Medicine Therapies for Pain Management in Cancer Patients. Cancer J. 2019 Sep/Oct;25(5):343-348. doi: 10.1097/PPO.0000000000000399.
PubMed 31567462
El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, Jackson VA, Telles J, Rhodes A, Spitzer TR, McAfee S, Chen YA, Lee SS, Temel JS. Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2016 Nov 22;316(20):2094-2103. doi: 10.1001/jama.2016.16786.
PubMed 27893130
Grulke N, Albani C, Bailer H. Quality of life in patients before and after haematopoietic stem cell transplantation measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30. Bone Marrow Transplant. 2012 Apr;47(4):473-82. doi: 10.1038/bmt.2011.107. Epub 2011 May 23.
PubMed 21602898
Zetzl T, Renner A, Pittig A, Jentschke E, Roch C, van Oorschot B. Yoga effectively reduces fatigue and symptoms of depression in patients with different types of cancer. Support Care Cancer. 2021 Jun;29(6):2973-2982. doi: 10.1007/s00520-020-05794-2. Epub 2020 Oct 7.
PubMed 33026490
Jim HS, Sutton SK, Jacobsen PB, Martin PJ, Flowers ME, Lee SJ. Risk factors for depression and fatigue among survivors of hematopoietic cell transplantation. Cancer. 2016 Apr 15;122(8):1290-7. doi: 10.1002/cncr.29877. Epub 2016 Jan 27.
PubMed 26814442
Liang J, Lee SJ, Storer BE, Shaw BE, Chow EJ, Flowers ME, Krakow EF, Bar M, Syrjala KL, Salit RB, Kurukulasuriya CE, Jim HSL. Rates and Risk Factors for Post-Traumatic Stress Disorder Symptomatology among Adult Hematopoietic Cell Transplant Recipients and Their Informal Caregivers. Biol Blood Marrow Transplant. 2019 Jan;25(1):145-150. doi: 10.1016/j.bbmt.2018.08.002. Epub 2018 Aug 9.
PubMed 30098393
Jeon M, Yoo IY, Kim S, Lee J. Post-traumatic growth in survivors of allogeneic hematopoietic stem cell transplantation. Psychooncology. 2015 Aug;24(8):871-7. doi: 10.1002/pon.3724. Epub 2014 Nov 10.
PubMed 25382562
Corman M, Rubio MT, Cabrespine A, Brindel I, Bay JO, De La Tour RP, Dambrun M. Retrospective and prospective measures of post-traumatic growth reflect different processes: longitudinal evidence of greater decline than growth following a hematopoietic stem-cell transplantation. BMC Psychiatry. 2021 Jan 11;21(1):27. doi: 10.1186/s12888-020-03007-y.
PubMed 33430807
Tick H, Nielsen A. Academic Consortium for Integrative Medicine & Health Commentary to Health and Human Services (HHS) on Inter-agency Task Force Pain Management Best Practices Draft Report. Glob Adv Health Med. 2019 Jul 17;8:2164956119857656. doi: 10.1177/2164956119857656. eCollection 2019. No abstract available.
PubMed 31360615
Nakao M. Heart Rate Variability and Perceived Stress as Measurements of Relaxation Response. J Clin Med. 2019 Oct 16;8(10):1704. doi: 10.3390/jcm8101704.
PubMed 31623225
Chen L, Michalsen A. Management of chronic pain using complementary and integrative medicine. BMJ. 2017 Apr 24;357:j1284. doi: 10.1136/bmj.j1284.
PubMed 28438745

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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation at the Hospital Israelita Albert Einstein
ClinicalTrials.gov ID: NCT06118853
Acronym / sponsor ID: Yoga / 61711022.6.0000.0071
Conditions: Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation
Keywords: Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation, Integrative Therapies, Yoga, Massage
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Hospital Israelita Albert EinsteinUniversity, hospital or other
Study start: 21 Nov 2023 (actual)
Primary completion: 30 Dec 2024 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 7 Nov 2023 (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

Secondary Objectives:

To analyze changes in the Quality-of-Life Scale during HSCT.
To analyze changes in the Religiosity Scale during HSCT.
To analyze the subjective experience of the patient during HSCT.
To analyze patient satisfaction during HSCT. Hypothesis: The practice of yoga or gentle massage combined with standard treatment is superior to standard treatment alone in symptom management in patients undergoing HSCT.

Inclusion Criteria: Adults aged 18 and above; admitted to HIAE, eligible for Bone Marrow Transplantation; patients who speak and read Portuguese.

Exclusion Criteria: Patients with hearing impairment; patients previously diagnosed with psychiatric disorders: schizophrenia.

Sample Size: The sample will consist of a minimum of 40 patients for this study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients will be randomized into two groups: Group A (control): standard treatment /Group B (intervention): yoga + gentle massage + standard treatment. Group B (intervention) will receive 8 individual integrative practice sessions at the bedside, each lasting 15 to 20 minutes, with 2 sessions per week during the following periods: from admission until D+0 / until D+7 / until D+14 / until D+21 or discharge. The therapist will choose the integrative practices that best suit the patient for each session, based on their psychophysical state and symptoms, as there can be many variations during HSCT. Group A (control) will receive 8 visits from integrative therapists who will remain in the patient's room, able to interact but without offering integrative practices, during the same periods described above. After D+21, these patients will also receive 8 integrative practice sessions at the bedside or in the Integrative Medicine room.

Arm	Type	Receives
Group A (control)	No intervention	–Standard treatment for HSCT
Group B (intervention)	Experimental	Behavioral: yoga or gentle massage plus standard treatment for HSCTYoga or gentle massage plus standard treatment for HSCT

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults aged 18 and above;
Admitted to HIAE, eligible for Bone Marrow Transplantation;
Patients who speak and read the Portuguese language.

Key exclusion criteria (2 listed)

Patients with hearing impairment;
Patients previously diagnosed with psychiatric disorder: schizophrenia.

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
yoga or gentle massage plus standard treatment for HSCTThe yoga sessions will be conducted at the patient's bedside, using one or more of the following techniques: gentle stretches (asanas), guided relaxation (savasana), slow and deep diaphragmatic breathing (pranayama), and meditative exercises focusing on natural breathing or visualization of a soothing place (dhyana). From these techniques, the integrative therapist will choose what best suits the patient for each session, based on their psychophysical state and symptoms presented, as there can be many variations during HSCT. Gentle massage is characterized by soft touches using light pressure, primarily using the palm of the hand, with a slow and steady rhythm across the entire body. It can be performed over clothing or even over the bedsheet and blanket.	Behavioural	Group B (intervention)

Primary outcome

Symptom Management: fatigue, pain, nausea, anxiety, and well-being
Time frame: The sessions will occur at the following time points: Session 1 and 2 - from admission to Day 0 (infusion) / Session 3 and 4: between Day 1 and Day 7 / Session 5 and 6: between Day 8 and Day 14 / Session 7 and 8: between Day 15 and Day 21 or discharge.
The Edmonton Symptom Assessment Scale will be administered both before and after each of the 8 sessions in both groups to evaluate pain, fatigue, nausea, anxiety, and well-being. The scale for each domain ranges from 0 to 10, where 0 signifies no symptoms or excellent well-being, and 10 signifies the most severe symptoms or worst possible well-being.

4 secondary outcomes

Scale of Quality-of-Life
Time frame: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Scale of Religiosity
Time frame: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Qualitative Report
Time frame: Day 21 or at discharge (whichever comes first).
Patient-Reported Experience Measures
Time frame: Day 21 or at discharge (whichever comes first).

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 20 Mar 2025.
Results publication: PubMed 31285665Bazinet A, Popradi G. A general practitioner's guide to hematopoietic stem-cell transplantation. Curr Oncol. 2019 Jun;26(3):187-191. doi: 10.3747/co.26.5033. Epub 2019 Jun 1.
Results publication: PubMed 20424252Gratwohl A, Baldomero H, Aljurf M, Pasquini MC, Bouzas LF, Yoshimi A, Szer J, Lipton J, Schwendener A, Gratwohl M, Frauendorfer K, Niederwieser D, Horowitz M, Kodera Y; Worldwide Network of Blood and Marrow Transplantation. Hematopoietic stem cell transplantation: a global perspective. JAMA. 2010 Apr 28;303(16):1617-24. doi: 10.1001/jama.2010.491.
Results publication: PubMed 32227211Foord AM, Cushing-Haugen KL, Boeckh MJ, Carpenter PA, Flowers MED, Lee SJ, Leisenring WM, Mueller BA, Hill JA, Chow EJ. Late infectious complications in hematopoietic cell transplantation survivors: a population-based study. Blood Adv. 2020 Apr 14;4(7):1232-1241. doi: 10.1182/bloodadvances.2020001470.
Results publication: PubMed 22699091Cohen MZ, Rozmus CL, Mendoza TR, Padhye NS, Neumann J, Gning I, Aleman A, Giralt S, Cleeland CS. Symptoms and quality of life in diverse patients undergoing hematopoietic stem cell transplantation. J Pain Symptom Manage. 2012 Aug;44(2):168-80. doi: 10.1016/j.jpainsymman.2011.08.011. Epub 2012 Jun 13.
Results publication: PubMed 31567462Deng G. Integrative Medicine Therapies for Pain Management in Cancer Patients. Cancer J. 2019 Sep/Oct;25(5):343-348. doi: 10.1097/PPO.0000000000000399.
Results publication: PubMed 27893130El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, Jackson VA, Telles J, Rhodes A, Spitzer TR, McAfee S, Chen YA, Lee SS, Temel JS. Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2016 Nov 22;316(20):2094-2103. doi: 10.1001/jama.2016.16786.
Results publication: PubMed 21602898Grulke N, Albani C, Bailer H. Quality of life in patients before and after haematopoietic stem cell transplantation measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30. Bone Marrow Transplant. 2012 Apr;47(4):473-82. doi: 10.1038/bmt.2011.107. Epub 2011 May 23.
Results publication: PubMed 33026490Zetzl T, Renner A, Pittig A, Jentschke E, Roch C, van Oorschot B. Yoga effectively reduces fatigue and symptoms of depression in patients with different types of cancer. Support Care Cancer. 2021 Jun;29(6):2973-2982. doi: 10.1007/s00520-020-05794-2. Epub 2020 Oct 7.
Results publication: PubMed 26814442Jim HS, Sutton SK, Jacobsen PB, Martin PJ, Flowers ME, Lee SJ. Risk factors for depression and fatigue among survivors of hematopoietic cell transplantation. Cancer. 2016 Apr 15;122(8):1290-7. doi: 10.1002/cncr.29877. Epub 2016 Jan 27.
Results publication: PubMed 30098393Liang J, Lee SJ, Storer BE, Shaw BE, Chow EJ, Flowers ME, Krakow EF, Bar M, Syrjala KL, Salit RB, Kurukulasuriya CE, Jim HSL. Rates and Risk Factors for Post-Traumatic Stress Disorder Symptomatology among Adult Hematopoietic Cell Transplant Recipients and Their Informal Caregivers. Biol Blood Marrow Transplant. 2019 Jan;25(1):145-150. doi: 10.1016/j.bbmt.2018.08.002. Epub 2018 Aug 9.
Results publication: PubMed 25382562Jeon M, Yoo IY, Kim S, Lee J. Post-traumatic growth in survivors of allogeneic hematopoietic stem cell transplantation. Psychooncology. 2015 Aug;24(8):871-7. doi: 10.1002/pon.3724. Epub 2014 Nov 10.
Results publication: PubMed 33430807Corman M, Rubio MT, Cabrespine A, Brindel I, Bay JO, De La Tour RP, Dambrun M. Retrospective and prospective measures of post-traumatic growth reflect different processes: longitudinal evidence of greater decline than growth following a hematopoietic stem-cell transplantation. BMC Psychiatry. 2021 Jan 11;21(1):27. doi: 10.1186/s12888-020-03007-y.
Individual participant dataSharing planned: No

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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.

Nelson Hamerschlak principal investigator

Hospital Israelita Albert Einstein

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

Questions about this trial

What is this clinical trial studying?

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 3 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 20 Mar 2025. 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 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?

Symptom Management: fatigue, pain, nausea, anxiety, and well-being (time frame: The sessions will occur at the following time points: Session 1 and 2 - from admission to Day 0 (infusion) / Session 3 and 4: between Day 1 and Day 7 / Session 5 and 6: between Day 8 and Day 14 / Session 7 and 8: between Day 15 and Day 21 or discharge.). 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 NCT06118853, which also lists 35 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 20 Mar 2025.