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Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT01582971
Recruitment Status : Completed
First Posted : April 23, 2012
Results First Posted : October 2, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University

Tracking Information
First Submitted Date  ICMJE April 17, 2012
First Posted Date  ICMJE April 23, 2012
Results First Submitted Date  ICMJE March 21, 2017
Results First Posted Date  ICMJE October 2, 2017
Last Update Posted Date April 18, 2018
Study Start Date  ICMJE April 17, 2012
Actual Primary Completion Date May 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Health Related Quality of Life [ Time Frame: 11 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Official Title  ICMJE Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Other: Reflexology
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
Study Arms  ICMJE
  • Experimental: Intervention
    Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member
    Intervention: Other: Reflexology
  • No Intervention: Control
    Standard medical care: no reflexology
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2017)
256
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
268
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01582971
Other Study ID Numbers  ICMJE 1R01CA157459-01( U.S. NIH Grant/Contract )
1R01CA157459-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gwen Wyatt, Michigan State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Michigan State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Gwen Wyatt, PhD, RN Michigan State University
PRS Account Michigan State University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP