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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation

Intervention / Treatment
-----------------
* Behavioral: yoga or gentle massage plus standard treatment for HSCT


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A (control)<br>Standard treatment for HSCT | |
| Experimental: Group B (intervention)<br>Yoga or gentle massage plus standard treatment for HSCT | Behavioral: yoga or gentle massage plus standard treatment for HSCT<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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). | 
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematopoietic Stem Cell Transplantation, Bone Marrow Transplantation, Integrative Therapies, Yoga, Massage