Clinical trial NCT02863302: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia, Reflexology
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Not willing to sign a consent form.

Primary outcomes:
measure: Change from baseline in the FACIT-D questionaire.
timeFrame: Change from baseline in the FACIT-D questionaire at 1,2,3, and 4 weeks from the beginning of chemotherapy treatment.
Secondary outcomes:
measure: To evaluate the effect of reflexology treatment on chemotherapy associated diarrhea
timeFrame: Diarrhea frequency will be recorded daily from the first day of chemotherapy and up to 30 days.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus, Haifa, Israel.
name: Netanel A Horowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.