Reflexology: An Intervention for Advanced Breast Cancer

NCT ID: NCT01577420

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 451 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2010-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group A

Reflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks.

Group Type: EXPERIMENTAL

Reflexology Sessions

Intervention Type: OTHER

One session per week performed by certified reflexologist for four consecutive weeks.

Group B

Placebo Sessions: One session per week performed by research aide for four consecutive weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Sessions

Intervention Type: OTHER

One session per week performed by research aide for four consecutive weeks.

Group C

Control; no foot sessions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reflexology Sessions

One session per week performed by certified reflexologist for four consecutive weeks.

Intervention Type: OTHER

Placebo Sessions

One session per week performed by research aide for four consecutive weeks.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Gwen Wyatt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gwen Wyatt, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Evanston Northwestern

Evanston, Illinois, United States

Mt. Clemens

Evanston, Illinois, United States

Hurley Medical Center

Flint, Michigan, United States

GLCI/McLaren

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, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19918155 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21664296 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20467309 (View on PubMed)

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 Feb 14.

Reference Type: RESULT

PMID: 19620179 (View on PubMed)

Other Identifiers

5R01CA104883-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01CA104883-05

Identifier Type: NIH

Identifier Source: org_study_id

View Link