- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01582971
Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Study Overview
Detailed Description
This project tests the benefits of a home-based intervention of foot reflexology for improving health-related quality of life (HRQOL) including symptom responses, functioning, and health perceptions in women treated with chemotherapy for advanced breast cancer. Reflexology applies a firm walking-motion during sessions and is based on the premise that the foot has reflexes mirroring organs of the body. Symptom burden is the strongest predictor of HRQOL for cancer patients. This project brings together expertise from nursing, reflexology, communication, statistics, and health economics. The primary specific aims, in a sample of women with advanced breast cancer receiving chemotherapy, are to determine the effects of a 4-week, home-based reflexology intervention delivered by a friend/family provider compared to attention control for improvement of:
HRQOL including symptoms, functioning, and health perception at study weeks 5 and 11.
The investigators hypothesize that the reflexology group will have better HRQOL (symptoms, functioning, and health perception) than the attention control group at study weeks 5 and 11.
Multiple symptom responses and times-to-response as determined by weekly symptom assessments during the 4-week intervention time.
The investigators hypothesize that the reflexology group will have a higher proportion of symptoms that respond to the intervention and shorter time-to-symptom-responses than the attention control group.
- Symptom-related use of unscheduled health services during the 11-week study. The investigators hypothesize that fewer unscheduled services will be used for symptom management over the 11-week study period by women receiving reflexology compared to women in the attention control.
The exploratory aims are to: 1) Explore differences between trial arms in perceptions of social support due to the family- or friend-delivered reflexology sessions at study weeks 5 and 11; 2) Determine if effects of the reflexology intervention on HRQOL are mediated by social support; and 3) Use the newly developed NIH PROMIS standardized symptom and functioning instruments to assess the effects of the reflexology intervention and to compare the responsiveness of PROMIS instruments and existing instruments designed to measure similar constructs.
This project has immense potential to make an effective symptom management intervention accessible to patients in their homes via a friend or family home provider. The investigators will not only intervene to enhance HRQOL but also to evaluate social support and costs associated with unscheduled health services. Effective symptom management provides time and cost savings to clinicians, advances the current state-of-the-science, and promotes adherence to medical treatment that may ultimately enhance survival.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 49201
- Northwestern
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Michigan
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, United States, 49503
- Lemmon-Holton Cancer Center
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Lansing, Michigan, United States, 48910
- Breslin Cancer Center
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Lansing, Michigan, United States, 48912
- Sparrow Cancer Center
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Mount Clemens, Michigan, United States, 48043
- McLaren Macomb
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Pontiac, Michigan, United States, 48241
- St. Joseph Mercy Oakland Hospital
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Royal Oak, Michigan, United States, 48073
- Beaumont Hospital
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Warren, Michigan, United States, 48093
- St. Johns Providence
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member
|
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
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No Intervention: Control
Standard medical care: no reflexology
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The M.D. Anderson Symptom Inventory (MDASI)
Time Frame: Week 5 and week 11
|
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
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Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0
Time Frame: Week 5 and week 11
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Higher scores representing better outcomes in each subscale. |
Week 5 and week 11
|
Quality of Life Index (QLI)
Time Frame: Week 5 and week 11
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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.
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Week 5 and week 11
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Use of Unscheduled Health Service
Time Frame: Week 11
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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.
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Week 11
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gwen Wyatt, PhD, RN, Michigan State University
Publications and helpful links
General Publications
- 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.
- Luo 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01CA157459-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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