Anxiety Disorder, Fatigue, Hematopoietic/Lymphoid Cancer, Pain
Conditions
Brief summary
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
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.
Interventions
PROCEDUREtherapeutic touch
receiving healing touch
OTHERquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline up to 100 days | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of hospital readmissions | Up to 100 days |
Countries
United States
Outcome results
None listed