Overview

This trial is active, not recruiting.

Conditions anxiety disorder, fatigue, hematopoietic/lymphoid cancer, pain
Treatments therapeutic touch, quality-of-life assessment, questionnaire administration
Sponsor University of Iowa
Collaborator National Cancer Institute (NCI)
Start date March 2012
End date September 2014
Trial size 40 participants
Trial identifier NCT02194413, 201111724, P30CA086862

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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
therapeutic touch healing touch
receiving healing touch
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Active Comparator)
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
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Length of hospital stay
time frame: Up to 100 days
Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater than 500 for 3 consecutive days
time frame: Up to 100 days
Number of hospital readmissions
time frame: Up to 100 days
Changes in QoL, measured using the Profile of Mood States-Short Form (POMS-SF), and the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: Baseline up to 100 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
Principal investigator Susan K Lutgendorf, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Iowa.