Reflexology: An Intervention for Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

Reflexology: An Intervention for Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577420
• Other study ID #: 5R01CA104883-05
• Secondary ID: 5R01CA104883-05
• Status: Completed
• Phase: N/A
• First received: April 12, 2012
• Last updated: April 12, 2012
• Start date: August 2005
• Est. completion date: August 2010

Study information

• Verified date: April 2012
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III or IV) breast cancer 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); and the outcome indicator of quality of life.

Description:

The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III and IV) breast cancer within the context of conventional medical care. This longitudinal randomized clinical trial (RCT) will test a three-group design in which participants will continue to receive conventional care. Two groups of the study will involve a single-blinded four-week protocol: Group A will receive reflexology (a specialized foot therapy) from a certified reflexologist; Group B will receive placebo sessions from a research aide. The control group (Group C) will receive conventional medical care alone. The specific aims are: 1) to determine if women who receive either Groups (A or B) of an experimental protocol (reflexology or placebo) report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone (Group C); 2) to determine if women who receive Group A of an experimental protocol (reflexology), report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving Group B (placebo; 3) to determine if women who receive either Group A or B of an experimental protocol (reflexology or placebo), report significant differences on Intermediate Indicators (physical and emotional), at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone; and 4) to determine if the Intermediate Indicators mediate the group effect on the QOL outcomes (total and subscales) at 7 weeks. This has the potential of leading to an enhanced system of care through the integration of conventional and scientifically-based complementary therapies. It also focuses on advanced disease that is currently under investigation in terms of supportive care measures. Finally, this study utilizes an improved design over existing work. It is a RCT with adequate numbers to detect group differences, and could ultimately serve as a model for rigorous investigation of other complementary therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Stage III or IV breast cancer, or Stage I or II with Metastasis or Recurrence

• Able to perform basic ADLs

• Free of diagnosis of mental illness on chart

• Able to speak and understand English

• Access to a telephone

• Receiving chemotherapy at intake into the study

• Palliative Prognostic Score of 11 or lower

• Oriented to time, place, and person as determined by nurse recruiter

Exclusion Criteria:

• Receiving investigational new drug chemotherapy

• Receiving hospice care at intake

• Living in nursing home or similar facility

• Bedridden

• Undergoing bone marrow transplant

• Regularly using foot massage

• Regularly using reflexology

• Regularly using pedicure with foot massage

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Reflexology Sessions
One session per week performed by certified reflexologist for four consecutive weeks.
• Placebo Sessions
One session per week performed by research aide for four consecutive weeks.

Locations

Country	Name	City	State
United States	Evanston Northwestern	Evanston	Illinois
United States	Mt. Clemens	Evanston	Illinois
United States	GLCI/McLaren	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	St. Joseph Mercy Oakland Hospital	Grand Rapids	Michigan
United States	St. Mary's Health Care Center	Grand Rapids	Michigan
United States	Great Lakes Cancer Institute (GLCI) MSU	Lansing	Michigan
United States	Sparrow Hospital	Lansing	Michigan
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	William Beaumont Hospital-Troy Campus	Troy	Michigan
United States	St. John Macomb	Warren	Michigan
United States	Josephine Ford Cancer Care, Henry Ford Hospital	West Bloomfield	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

Sikorskii A, Wyatt GK, Siddiqi AE, Tamkus D. Recruitment and early retention of women with advanced breast cancer in a complementary and alternative medicine trial. Evid Based Complement Alternat Med. 2011;2011:734517. doi: 10.1093/ecam/nep051. Epub 2011 — View Citation

Wyatt G, Sikorskii A, Rahbar MH, Victorson D, Adams L. Intervention fidelity: aspects of complementary and alternative medicine research. Cancer Nurs. 2010 Sep-Oct;33(5):331-42. doi: 10.1097/NCC.0b013e3181d0b4b7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life		Baseline to week 13	No