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Reflexology: An Intervention for Advanced Breast Cancer


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Reflexology: An Intervention for Advanced Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Health Related Quality of Life

Outcome Time Frame:

Baseline to week 13

Safety Issue:

No

Principal Investigator

Gwen Wyatt, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Michigan State University

Authority:

United States: Institutional Review Board

Study ID:

5R01CA104883-05

NCT ID:

NCT01577420

Start Date:

August 2005

Completion Date:

August 2010

Related Keywords:

  • Breast Cancer
  • Reflexology
  • Breast Cancer
  • Complementary
  • Breast Neoplasms

Name

Location

Hurley Medical CenterFlint, Michigan  48503
William Beaumont HospitalRoyal Oak, Michigan  48073
St. Joseph Mercy Oakland HospitalPontiac, Michigan  33308
Sparrow HospitalLansing, Michigan  48912
Evanston NorthwesternEvanston, Illinois  60201
Mt. ClemensEvanston, Illinois  60201
GLCI/McLarenFlint, Michigan  48532
St. Mary's Health Care CenterGrand Rapids, Michigan  49503
Great Lakes Cancer Institute (GLCI) MSULansing, Michigan  48910
William Beaumont Hospital-Troy CampusTroy, Michigan  48085
St. John MacombWarren, Michigan  48093
Josephine Ford Cancer Care, Henry Ford HospitalWest Bloomfield, Michigan  48323