Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
1 other identifier
interventional
256
1 country
9
Brief Summary
The purpose of this project is to test foot reflexology delivered by a friend or family member in the home for women with breast cancer. The primary aims of the proposed study in a sample of women with breast cancer receiving chemotherapy and/or hormonal therapy are to determine the effects of 4 family- or friend-delivered weekly reflexology sessions compared to an attention control group.
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 Apr 2012
Typical duration for not_applicable breast-cancer
9 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
First Submitted
Initial submission to the registry
April 17, 2012
CompletedStudy Start
First participant enrolled
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
October 2, 2017
CompletedApril 18, 2018
March 1, 2018
4 years
April 17, 2012
March 21, 2017
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The M.D. Anderson Symptom Inventory (MDASI)
The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived. Higher symptom severity and interference scores represent worse outcome.
Week 5 and week 11
Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0
1. PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population. 2. PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population. Higher scores representing better outcomes in each subscale.
Week 5 and week 11
Quality of Life Index (QLI)
The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.
Week 5 and week 11
Use of Unscheduled Health Service
Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.
Week 11
Study Arms (2)
Intervention
EXPERIMENTALReflexology: 4 weekly foot reflexology sessions delivered by friend/family member
Control
NO INTERVENTIONStandard medical care: no reflexology
Interventions
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
Eligibility Criteria
You may qualify if:
- Age ≥ 21
- Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence
- Able to perform basic ADLs
- Undergoing chemotherapy and/or hormonal therapy for breast cancer
- Able to speak and understand English
- Have access to a telephone
- Able to hear normal conversation
- Cognitively oriented to time, place, and person (determined via nurse recruiter)
You may not qualify if:
- Diagnosis of major mental illness on the medical record and verified by the recruiter
- Residing in a nursing home
- Bedridden
- Currently receiving regular reflexology
- Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (9)
Northwestern
Chicago, Illinois, 49201, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Lemmon-Holton Cancer Center
Grand Rapids, Michigan, 49503, United States
Breslin Cancer Center
Lansing, Michigan, 48910, United States
Sparrow Cancer Center
Lansing, Michigan, 48912, United States
McLaren Macomb
Mount Clemens, Michigan, 48043, United States
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48241, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. Johns Providence
Warren, Michigan, 48093, United States
Related Publications (2)
Sikorskii A, Niyogi PG, Victorson D, Tamkus D, Wyatt G. Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer. Support Care Cancer. 2020 Mar;28(3):1395-1404. doi: 10.1007/s00520-019-04959-y. Epub 2019 Jul 2.
PMID: 31267277DERIVEDLuo Z, Wang L, Sikorskii A, Wyatt G. Healthcare service utilization and work-related productivity in reflexology intervention for advanced breast cancer women. Support Care Cancer. 2019 Aug;27(8):2837-2847. doi: 10.1007/s00520-018-4592-4. Epub 2018 Dec 14.
PMID: 30552595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gwen Wyatt
- Organization
- Michigan State University
Study Officials
- PRINCIPAL INVESTIGATOR
Gwen Wyatt, PhD, RN
Michigan State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 23, 2012
Study Start
April 17, 2012
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
April 18, 2018
Results First Posted
October 2, 2017
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share