Clinical trial NCT06118853: Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Bone Marrow Transplantation
Keywords: Hematopoietic Stem Cell Transplantation
Bone Marrow Transplantation
Integrative Therapies
Yoga
Massage
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Symptom Management: fatigue, pain, nausea, anxiety, and well-being
timeFrame: 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:
measure: Scale of Quality-of-Life
timeFrame: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
measure: Scale of Religiosity
timeFrame: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
measure: Qualitative Report
timeFrame: Day 21 or at discharge (whichever comes first).
measure: Patient-Reported Experience Measures
timeFrame: Day 21 or at discharge (whichever comes first).
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Maria Ester Azevedo Massola
state: SP
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Nelson Hamerschlak
role: PRINCIPAL_INVESTIGATOR
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