Clinical trial NCT02194413: Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
Official title: Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Fatigue
Hematopoietic/Lymphoid Cancer
Pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
timeFrame: Up to 100 days
measure: Changes in QoL (POMS-SF, FACT-BMT, CES-D)
timeFrame: Baseline up to 100 days
Secondary outcomes:
measure: Number of hospital readmissions
timeFrame: Up to 100 days
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Susan K Lutgendorf, PhD
role: PRINCIPAL_INVESTIGATOR
References: