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

NCT02863302 | Unknown

• 1 other identifier: 0107-16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, Reflexology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Reflexology treatment

EXPERIMENTAL

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.

Other: Reflexology treatment

Interventions

Reflexology treatment OTHER

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

Reflexology treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not willing to sign a consent form.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 21664296 RESULT

• 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.

  PMID: 19918155 RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Netanel A Horowitz, MD

  Rambam Health Care Campus, Haifa, Israel.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Netanel A Horowitz, MD

CONTACT

97247772541; n_horowitz@rambam.health.gov.il

Limor Dan, Msc

CONTACT

97247772541; l_dan@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ambulatory unit , hematology division

Study Record Dates

• First Submitted: July 10, 2016
• First Posted: August 11, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)