NCT00321880

Brief Summary

RATIONALE: Supportive care, such as healing touch, may improve quality of life in patients receiving chemotherapy for acute leukemia. PURPOSE: This clinical trial is studying how well healing touch works in treating patients receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration 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

February 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 30, 2017

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

May 2, 2006

Last Update Submit

May 25, 2017

Conditions

FatigueLeukemiaPsychosocial Effects of Cancer and Its Treatment

Keywords

fatiguepsychosocial effects of cancer and its treatmentadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (2)

  • Feasibility of recruiting and retaining patients for a randomized controlled trial to study healing touch (HT) as supportive care

    4 weeks

  • Effectiveness of healing touch on reducing psychological stress and fatigue

    4 weeks

Interventions

therapeutic touchPROCEDURE

administration of healing touch in 30 minute sessions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of one of the following acute leukemias: * Acute lymphocytic leukemia * Acute myeloid leukemia * Hospitalized for induction (newly diagnosed patients) or reinduction (relapsed patients) chemotherapy * Must be oncology inpatients at Wake Forest University Baptist Medical Center PATIENT CHARACTERISTICS: * Must know adequate English to understand the consent form, complete questionnaires, and converse with study staff PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

FatigueLeukemiaCongenital AbnormalitiesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Suzanne C. Danhauer, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2007

Study Completion

October 1, 2008

Last Updated

May 30, 2017

Record last verified: 2012-07

Locations

US(1)