Reflexology: An Intervention for Advanced Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Placebo Sessions; Other: Reflexology Sessions

• Registration Number: NCT01577420
• Lead Sponsor: Michigan State University

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 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.

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 Timeline

• Study Start: 2005-08
• Primary Completion: 2010-04
• Study Completion: 2010-08
• Status Verified: 2012-04
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-12
• Last Update Submitted: 2012-04-12
• Study First Posted: 2012-04-13
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 451

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Placebo Sessions	Placebo Sessions: One session per week performed by research aide for four consecutive weeks.
Group A	Reflexology Sessions	Reflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life	Baseline to week 13

Trial Locations

Locations (12)

Mt. Clemens; 🇺🇸 Evanston, Illinois, United States

Hurley Medical Center; 🇺🇸 Flint, Michigan, United States

Great Lakes Cancer Institute (GLCI) MSU; 🇺🇸 Lansing, Michigan, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

St. Joseph Mercy Oakland Hospital; 🇺🇸 Grand Rapids, Michigan, United States

GLCI/McLaren; 🇺🇸 Flint, Michigan, United States

St. Mary's Health Care Center; 🇺🇸 Grand Rapids, Michigan, United States

Sparrow Hospital; 🇺🇸 Lansing, Michigan, United States

St. John Macomb; 🇺🇸 Warren, Michigan, United States

Josephine Ford Cancer Care, Henry Ford Hospital; 🇺🇸 West Bloomfield, Michigan, United States

Evanston Northwestern; 🇺🇸 Evanston, Illinois, United States

William Beaumont Hospital-Troy Campus; 🇺🇸 Troy, Michigan, United States