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Reflexology: An Intervention for Acute Myeloid Leukemia(AML) Patients

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Reflexology treatment
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, Reflexology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of AML
  • chemotherapy treatment
  • signing a consent form.

Exclusion Criteria:

• Not willing to sign a consent form.

Sites / Locations

  • Rambam Health Care CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reflexology treatment

Arm Description

All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment until the end of hospitalization.

Outcomes

Primary Outcome Measures

Change from baseline in the FACIT-D questionaire.

Secondary Outcome Measures

To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea
Diarrhea frequency will be recorded daily by the nursing staff and entered into the patients medical chart.

Full Information

First Posted
July 10, 2016
Last Updated
February 14, 2017
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02863302
Brief Title
Reflexology: An Intervention for Acute Myeloid Leukemia(AML) Patients
Official Title
Reflexology Treatment for Newly Diagnosed AML Patients, Can it Reduce GI Tract Side Effects, and Improve and Improve Patients Mood.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia. within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); by a specific questionnaire. 3) chemotherapy side effects associated with the digestive system.
Detailed Description
The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute myeloid leukemia within the context of conventional medical care. This open study will test a one group design in which participants will continue to receive conventional care. All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment. The specific aims are: 1) to evaluate the effect of reflexology treatment on chemotherapy side effects effecting the digestive system. 2) to evaluate the effect of reflexology treatment on Quality of life. The assessment of the treatment will be executed on the FACIT-D VERSION 3.The influences of the treatment will also be evaluated by the nursing staff, in order to describe the patient's mental health and the condition of his intestinal movement.The side effect before during and after the chemotherapy treatment will be compared using the questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, Reflexology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reflexology treatment
Arm Type
Experimental
Arm Description
All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment until the end of hospitalization.
Intervention Type
Other
Intervention Name(s)
Reflexology treatment
Intervention Description
All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.
Primary Outcome Measure Information:
Title
Change from baseline in the FACIT-D questionaire.
Time Frame
Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.
Secondary Outcome Measure Information:
Title
To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea
Description
Diarrhea frequency will be recorded daily by the nursing staff and entered into the patients medical chart.
Time Frame
Diarrhea frequency will be recorded daily from the first day of chemotherapy and up to 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of AML chemotherapy treatment signing a consent form. Exclusion Criteria: • Not willing to sign a consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Netanel A Horowitz, MD
Phone
97247772541
Email
n_horowitz@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Limor Dan, Msc
Phone
97247772541
Email
l_dan@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Netanel A Horowitz, MD
Organizational Affiliation
Rambam Health Care Campus, Haifa, Israel.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neatanel A Horowitz, MD
Phone
97247772541
Email
n_horowitz@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Limor Dan
Phone
97247772541
Email
l_dan@rambam.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21664296
Citation
Rahbar MH, Wyatt G, Sikorskii A, Victorson D, Ardjomand-Hessabi M. Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial. Contemp Clin Trials. 2011 Sep;32(5):620-9. doi: 10.1016/j.cct.2011.05.015. Epub 2011 Jun 2.
Results Reference
result
PubMed Identifier
19918155
Citation
Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe.
Results Reference
result

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Reflexology: An Intervention for Acute Myeloid Leukemia(AML) Patients

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