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

Not Applicable

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT02863302
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2016-07-10
• Study First Submitted QC: 2016-08-07
• Study First Posted: 2016-08-11
• Study Start: 2017-01-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Not willing to sign a consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in the FACIT-D questionaire.	Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea	Diarrhea frequency will be recorded daily from the first day of chemotherapy and up to 30 days.	Diarrhea frequency will be recorded daily by the nursing staff and entered into the patients medical chart.

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel