Reflexology: An Intervention for Advanced Breast Cancer
1 other identifier
interventional
451
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Aug 2005
Longer than P75 for not_applicable breast-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 13, 2012
CompletedApril 13, 2012
April 1, 2012
4.7 years
April 12, 2012
April 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health Related Quality of Life
Baseline to week 13
Study Arms (3)
Group A
EXPERIMENTALReflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks.
Group B
PLACEBO COMPARATORPlacebo Sessions: One session per week performed by research aide for four consecutive weeks.
Group C
NO INTERVENTIONControl; no foot sessions
Interventions
One session per week performed by certified reflexologist for four consecutive weeks.
One session per week performed by research aide for four consecutive weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (12)
Evanston Northwestern
Evanston, Illinois, 60201, United States
Mt. Clemens
Evanston, Illinois, 60201, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
GLCI/McLaren
Flint, Michigan, 48532, United States
St. Joseph Mercy Oakland Hospital
Grand Rapids, Michigan, 44405, United States
St. Mary's Health Care Center
Grand Rapids, Michigan, 49503, United States
Great Lakes Cancer Institute (GLCI) MSU
Lansing, Michigan, 48910, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital-Troy Campus
Troy, Michigan, 48085, United States
St. John Macomb
Warren, Michigan, 48093, United States
Josephine Ford Cancer Care, Henry Ford Hospital
West Bloomfield, Michigan, 48323, United States
Related Publications (4)
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.
PMID: 19918155BACKGROUNDRahbar 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.
PMID: 21664296BACKGROUNDWyatt 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.
PMID: 20467309BACKGROUNDSikorskii 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.
PMID: 19620179RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gwen Wyatt, PhD, RN
Michigan State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 12, 2012
First Posted
April 13, 2012
Study Start
August 1, 2005
Primary Completion
April 1, 2010
Study Completion
August 1, 2010
Last Updated
April 13, 2012
Record last verified: 2012-04