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

Hematopoietic Stem Cell Transplantation Clinical Trial

— Yoga  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118853
• Other study ID #: 61711022.6.0000.0071
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: Hospital Israelita Albert Einstein
• Contact: Maria Ester A Massola, BA
• Phone: 55 11 996856500
• Email: ester.azevedo[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Marrow Transplantation
• Hematopoietic Stem Cell Transplantation

Intervention

Behavioral:
• yoga or gentle massage plus standard treatment for HSCT
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.

Locations

Country	Name	City	State
Brazil	Maria Ester Azevedo Massola	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (35)

Ahles TA, Tope DM, Pinkson B, Walch S, Hann D, Whedon M, Dain B, Weiss JE, Mills L, Silberfarb PM. Massage therapy for patients undergoing autologous bone marrow transplantation. J Pain Symptom Manage. 1999 Sep;18(3):157-63. doi: 10.1016/s0885-3924(99)000 — View Citation

Bakshi N, Cooley A, Ross D, Hawkins L, Sullivan M, Astles R, Sinha C, Katoch D, Peddineni M, Gee BE, Lane PA, Krishnamurti L. A pilot study of the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease. Complement Ther Med. — View Citation

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. — View Citation

Boyd C, Crawford C, Paat CF, Price A, Xenakis L, Zhang W; Evidence for Massage Therapy (EMT) Working Group. The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cance — View Citation

Brandow AM, Carroll CP, Creary S, Edwards-Elliott R, Glassberg J, Hurley RW, Kutlar A, Seisa M, Stinson J, Strouse JJ, Yusuf F, Zempsky W, Lang E. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain — View Citation

Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9. doi: 10.1016/j.jpainsymman.2003.12.016. — View Citation

Chen L, Michalsen A. Management of chronic pain using complementary and integrative medicine. BMJ. 2017 Apr 24;357:j1284. doi: 10.1136/bmj.j1284. — View Citation

Clarke TC, Barnes PM, Black LI, Stussman BJ, Nahin RL. Use of Yoga, Meditation, and Chiropractors Among U.S. Adults Aged 18 and Over. NCHS Data Brief. 2018 Nov;(325):1-8. — View Citation

Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Report. 2015 Feb 10;(79):1-16. — View Citation

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: 10.101 — View Citation

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 — View Citation

Cramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1(1):CD010802. doi: 10. — View Citation

Cramer H, Lauche R, Langhorst J, Paul A, Michalsen A, Dobos G. Predictors of yoga use among internal medicine patients. BMC Complement Altern Med. 2013 Jul 13;13:172. doi: 10.1186/1472-6882-13-172. — View Citation

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. — View Citation

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 Transplantatio — View Citation

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):12 — View Citation

Gonzalez M, Pascoe MC, Yang G, de Manincor M, Grant S, Lacey J, Firth J, Sarris J. Yoga for depression and anxiety symptoms in people with cancer: A systematic review and meta-analysis. Psychooncology. 2021 Aug;30(8):1196-1208. doi: 10.1002/pon.5671. Epub — View Citation

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 transpl — View Citation

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 Marro — View Citation

Hoffman JW, Benson H, Arns PA, Stainbrook GL, Landsberg GL, Young JB, Gill A. Reduced sympathetic nervous system responsivity associated with the relaxation response. Science. 1982 Jan 8;215(4529):190-2. doi: 10.1126/science.7031901. — View Citation

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. — View Citation

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. — View Citation

Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10 — View Citation

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 — View Citation

Lyman GH, Greenlee H, Bohlke K, Bao T, DeMichele AM, Deng GE, Fouladbakhsh JM, Gil B, Hershman DL, Mansfield S, Mussallem DM, Mustian KM, Price E, Rafte S, Cohen L. Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SI — View Citation

Mao JJ, Pillai GG, Andrade CJ, Ligibel JA, Basu P, Cohen L, Khan IA, Mustian KM, Puthiyedath R, Dhiman KS, Lao L, Ghelman R, Caceres Guido P, Lopez G, Gallego-Perez DF, Salicrup LA. Integrative oncology: Addressing the global challenges of cancer preventi — View Citation

Mao JJ, Wagner KE, Seluzicki CM, Hugo A, Galindez LK, Sheaffer H, Fox KR. Integrating Oncology Massage Into Chemoinfusion Suites: A Program Evaluation. J Oncol Pract. 2017 Mar;13(3):e207-e216. doi: 10.1200/JOP.2016.015081. Epub 2017 Jan 3. — View Citation

McCall MC, Ward A, Heneghan C. Yoga in adult cancer: a pilot survey of attitudes and beliefs among oncologists. Curr Oncol. 2015 Feb;22(1):13-9. doi: 10.3747/co.22.2129. — View Citation

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. — View Citation

Shin ES, Seo KH, Lee SH, Jang JE, Jung YM, Kim MJ, Yeon JY. Massage with or without aromatherapy for symptom relief in people with cancer. Cochrane Database Syst Rev. 2016 Jun 3;2016(6):CD009873. doi: 10.1002/14651858.CD009873.pub3. — View Citation

Swarm RA, Paice JA, Anghelescu DL, Are M, Bruce JY, Buga S, Chwistek M, Cleeland C, Craig D, Gafford E, Greenlee H, Hansen E, Kamal AH, Kamdar MM, LeGrand S, Mackey S, McDowell MR, Moryl N, Nabell LM, Nesbit S; BCPS; O'Connor N, Rabow MW, Rickerson E, Sha — View Citation

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: 10.117 — View Citation

Vadiraja HS, Raghavendra RM, Nagarathna R, Nagendra HR, Rekha M, Vanitha N, Gopinath KS, Srinath BS, Vishweshwara MS, Madhavi YS, Ajaikumar BS, Ramesh BS, Nalini R, Kumar V. Effects of a yoga program on cortisol rhythm and mood states in early breast canc — View Citation

Witt CM, Balneaves LG, Cardoso MJ, Cohen L, Greenlee H, Johnstone P, Kucuk O, Mailman J, Mao JJ. A Comprehensive Definition for Integrative Oncology. J Natl Cancer Inst Monogr. 2017 Nov 1;2017(52). doi: 10.1093/jncimonographs/lgx012. — View Citation

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 — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Secondary	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.	Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Secondary	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?"	Day 21 or at discharge (whichever comes first).
Secondary	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.	Day 21 or at discharge (whichever comes first).