NCT02194413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

July 16, 2014

Last Update Submit

January 30, 2017

Conditions

Anxiety DisorderFatigueHematopoietic/Lymphoid CancerPain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of hospital readmissions

    Up to 100 days

Study Arms (2)

Arm 1 (healing touch)

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

Procedure: therapeutic touchOther: quality-of-life assessmentOther: questionnaire administration

Arm II (usual care)

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

Other: quality-of-life assessmentOther: questionnaire administration

Interventions

therapeutic touchPROCEDURE

receiving healing touch

Also known as: healing touch
Arm 1 (healing touch)
quality-of-life assessmentOTHER

Ancillary studies

Also known as: quality of life assessment
Arm 1 (healing touch)Arm II (usual care)
questionnaire administrationOTHER

Ancillary studies

Arm 1 (healing touch)Arm II (usual care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Anxiety DisordersFatigueHematologic NeoplasmsPain

Interventions

Therapeutic TouchTouch

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Susan K Lutgendorf, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

March 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 18, 2017

Last Updated

February 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)