Reflexology: An Intervention for Advanced Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University
ClinicalTrials.gov Identifier:
NCT01577420
First received: April 12, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Reflexology Sessions
Other: Placebo Sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Reflexology: An Intervention for Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Health Related Quality of Life [ Time Frame: Baseline to week 13 ] [ Designated as safety issue: No ]

Enrollment: 451
Study Start Date: August 2005
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577420

Locations
United States, Illinois
Evanston Northwestern
Evanston, Illinois, United States, 60201
Mt. Clemens
Evanston, Illinois, United States, 60201
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
GLCI/McLaren
Flint, Michigan, United States, 48532
St. Joseph Mercy Oakland Hospital
Grand Rapids, Michigan, United States, 44405
St. Mary's Health Care Center
Grand Rapids, Michigan, United States, 49503
Sparrow Hospital
Lansing, Michigan, United States, 48912
Great Lakes Cancer Institute (GLCI) MSU
Lansing, Michigan, United States, 48910
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital-Troy Campus
Troy, Michigan, United States, 48085
St. John Macomb
Warren, Michigan, United States, 48093
Josephine Ford Cancer Care, Henry Ford Hospital
West Bloomfield, Michigan, United States, 48323
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Gwen Wyatt, PhD, RN Michigan State University
  More Information

Publications:
Responsible Party: Gwen Wyatt, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01577420     History of Changes
Other Study ID Numbers: 5R01CA104883-05, 5R01CA104883-05
Study First Received: April 12, 2012
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
Reflexology
Breast Cancer
Complementary

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014