Know Cancer

or
forgot password

Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study


N/A
18 Years
N/A
Not Enrolling
Both
Fatigue, Leukemia, Psychosocial Effects of Cancer and Its Treatment

Thank you

Trial Information

Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Study


OBJECTIVES:

- Determine the feasibility of conducting a randomized controlled trial, in terms of
recruiting and retaining participants, to a study of healing touch (HT) as supportive
care in patients receiving chemotherapy for acute myeloid leukemia or acute
lymphoblastic leukemia.

- Examine potential barriers to participation and ascertain reasons for study drop-outs
in these patients.

- Demonstrate whether these patients will comply with treatment sessions and remain in
the study.

- Obtain preliminary data on the effectiveness of HT on psychological distress and
treatment-related symptoms focusing on fatigue and sleep disturbances in these
patients.

- Determine if the HT protocol needs to be refined, modified, or eliminated, based on
pilot participant feedback, for a randomized clinical trial.

OUTLINE: This is a pilot study.

Within 1 week of admission to the hospital, patients are interviewed by a research assistant
about previous use of complementary or alternative medicine therapies, knowledge of healing
touch (HT), previous experience with HT, willingness to participate in a study of HT for
acute leukemia patients, and willingness to be randomized in a HT study. The first 12
patients interested in undergoing HT undergo a 30-minute session of HT therapy 3 times a
week during weeks 2, 3, and 4 of induction or reinduction chemotherapy. Patients are also
asked to rate current distress, pain, fatigue, and nausea before and after the second HT
session during weeks 2, 3, and 4. Patients also complete self-report questionnaires at
baseline, during week 5 of induction or reinduction chemotherapy or prior to discharge from
the hospital, and during the first week of consolidation chemotherapy (approximately week
9-13).

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Suzanne C. Danhauer, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000471996

NCT ID:

NCT00321880

Start Date:

February 2006

Completion Date:

October 2008

Related Keywords:

  • Fatigue
  • Leukemia
  • Psychosocial Effects of Cancer and Its Treatment
  • fatigue
  • psychosocial effects of cancer and its treatment
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult 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 leukemia
  • recurrent adult acute myeloid leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • Fatigue
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096