Clinical trial NCT01577420: Reflexology: An Intervention for Advanced Breast Cancer
Official title: Reflexology: An Intervention for Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Reflexology
Breast Cancer
Complementary
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-13
Enrollment: 451
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: Baseline to week 13
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Northwestern
state: Illinois
city: Evanston
country: United States
facility: Mt. Clemens
state: Illinois
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Flint
country: United States
facility: GLCI/McLaren
state: Michigan
city: Grand Rapids
country: United States
facility: St. Joseph Mercy Oakland Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: St. Mary's Health Care Center
state: Michigan
city: Lansing
country: United States
facility: Great Lakes Cancer Institute (GLCI) MSU
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital-Troy Campus
state: Michigan
city: Warren
country: United States
facility: St. John Macomb
state: Michigan
city: West Bloomfield
country: United States
facility: Josephine Ford Cancer Care, Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Michigan State University
name: Gwen Wyatt, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.