Reflexology: An Intervention for Advanced Breast Cancer

April 12, 2012 updated by: Gwen Wyatt, Michigan State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern
      • Evanston, Illinois, United States, 60201
        • Mt. Clemens
    • Michigan
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48532
        • GLCI/McLaren
      • Grand Rapids, Michigan, United States, 44405
        • St. Joseph Mercy Oakland Hospital
      • Grand Rapids, Michigan, United States, 49503
        • St. Mary's Health Care Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Lansing, Michigan, United States, 48910
        • Great Lakes Cancer Institute (GLCI) MSU
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital-Troy Campus
      • Warren, Michigan, United States, 48093
        • St. John Macomb
      • West Bloomfield, Michigan, United States, 48323
        • Josephine Ford Cancer Care, Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Reflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks.
Other: Reflexology Sessions
One session per week performed by certified reflexologist for four consecutive weeks.
Placebo Comparator: Group B
Placebo Sessions: One session per week performed by research aide for four consecutive weeks.
Other: Placebo Sessions
One session per week performed by research aide for four consecutive weeks.
No Intervention: Group C
Control; no foot sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health Related Quality of Life
Time Frame: Baseline to week 13
Baseline to week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gwen Wyatt, PhD, RN, Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

April 13, 2012

Last Update Submitted That Met QC Criteria

April 12, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01CA104883-05 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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