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Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582971
First Posted: April 23, 2012
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University
  Purpose
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.

Condition Intervention
Breast Cancer Other: Reflexology

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Gwen Wyatt, Michigan State University:

Primary Outcome Measures:
  • 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 (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling), and the interference of these symptoms with daily life. Summed symptom severity and interference scores were derived from this instrument.

    Higher score representing worse outcome.


  • Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 [ Time Frame: Week 5 and week 11 ]
    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.


  • Quality of Life Index (QLI) [ Time Frame: Week 5 and week 11 ]
    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.

  • Use of Unscheduled Health Service [ Time Frame: Week 11 ]
    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.


Enrollment: 256
Study Start Date: April 17, 2012
Estimated Study Completion Date: November 2017
Primary Completion Date: May 1, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member
Other: Reflexology
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
No Intervention: Control
Standard medical care: no reflexology

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:

  1. 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.

  2. 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.

  3. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582971


Locations
United States, Illinois
Northwestern
Chicago, Illinois, United States, 49201
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
Lemmon-Holton Cancer Center
Grand Rapids, Michigan, United States, 49503
Breslin Cancer Center
Lansing, Michigan, United States, 48910
Sparrow Cancer Center
Lansing, Michigan, United States, 48912
McLaren Macomb
Mount Clemens, Michigan, United States, 48043
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48241
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
St. Johns Providence
Warren, Michigan, United States, 48093
Sponsors and Collaborators
Michigan State University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gwen Wyatt, PhD, RN Michigan State University
  More Information

Responsible Party: Gwen Wyatt, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01582971     History of Changes
Other Study ID Numbers: 1R01CA157459-01 ( U.S. NIH Grant/Contract )
First Submitted: April 17, 2012
First Posted: April 23, 2012
Results First Submitted: March 21, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gwen Wyatt, Michigan State University:
Breast Cancer
Reflexology
Complementary

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases