Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

Study Overview
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Brief Summary
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This randomized pilot clinical trial studies healing touch or usual care in improving quality of life in patients undergoing stem cell transplant. Healing touch may improve the quality of life of patients undergoing stem cell transplant.

Detailed Description
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Primary Objectives: I. To estimate the effects of healing touch (HT) vs usual care in the following clinical outcomes of stem cell transplant (SCT) patients; length of hospital stay, days to engraftment, and number of hospital readmissions during 100 days post-transplant. II. To estimate changes in quality of life (QoL) which occur during hospitalization of SCT patients who receive HT vs. usual care. III. To examine differences in effects of HT vs. usual care (UC) in patients receiving related allogeneic (Allo) transplant compared to those receiving autologous (Auto) transplant. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital. ARM II: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital. After completion of study treatment, patients are followed up for 100 days.

Official Title
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Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

Conditions
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Pain, Anxiety Disorder, Fatigue, Hematopoietic/Lymphoid Cancer

Intervention / Treatment
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* Procedure: therapeutic touch
* Other: quality-of-life assessment
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently undergoing autologous (auto) or related allogeneic (related allo) stem cell transplantation Admitted to the University (U) Adult Blood and Bone Marrow Transplant Unit (UIBMTU) of the University of Iowa Hospitals and Clinic Ability to provide written informed consent obtained prior to participation in the study and able to complete questionnaires Pregnant woman who are eligible for stem cell transplant are included in this study Exclusion Criteria: Patients with any significant history of non-compliance to medical regimens, with inability to grant a reliable informed consent or unable to complete questionnaires Patients with evidence of a significant psychiatric disorder by history that would prevent completion of the study will not be allowed to participate, i.e., schizophrenia, anxiety disorder, major depressive disorder and bipolar disorder Diagnosis of dementia or other disease affecting cognitive function Nursing women are excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (healing touch)<br>Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital (therapeutic touch). Interventions: therapeutic touch, quality-of-life assessment, and questionnaire administration | Procedure: therapeutic touch<br>* receiving healing touch<br>* Other names: healing touch;Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (usual care)<br>Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital. Interventions: quality-of-life assessment, and questionnaire administration | Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater |  | Up to 100 days | 
| Changes in QoL (POMS-SF, FACT-BMT, CES-D) | Changes in levels of QoL measures before and after hospitalization will be compared using the paired t-test or the nonparametric paired sign test, if the assumption of normality is substantially violated. | Baseline up to 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital readmissions |  | Up to 100 days |