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

NCT ID: NCT02863302

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-06-30

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Reflexology treatment

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.

Group Type: EXPERIMENTAL

Reflexology treatment

Intervention Type: OTHER

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

Interventions

Reflexology treatment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Not willing to sign a consent form.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Netanel Horowitz MD

Head of ambulatory unit , hematology division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Netanel A Horowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus, Haifa, Israel.

Locations

Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Netanel A Horowitz, MD

Role: CONTACT

n_horowitz@rambam.health.gov.il

97247772541

Limor Dan, Msc

Role: CONTACT

l_dan@rambam.health.gov.il

97247772541

Facility Contacts

Neatanel A Horowitz, MD

Role: primary

n_horowitz@rambam.health.gov.il

97247772541

Limor Dan

Role: backup

l_dan@rambam.health.gov.il

97247772541

References

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.

Reference Type: RESULT

PMID: 21664296 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19918155 (View on PubMed)

Other Identifiers

0107-16

Identifier Type: -

Identifier Source: org_study_id