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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: November 6, 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
Results First Submitted: March 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Other: Reflexology

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention

Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.

Friend/family member was trained in foot reflexology protocol by certified reflexologist.

Friend/family member provides 4 weekly sessions to patient.

Control Standard medical care: no reflexology.

Participant Flow:   Overall Study
    Intervention   Control
STARTED   128   128 
COMPLETED   89   91 
NOT COMPLETED   39   37 
Death                2                1 
Lost to Follow-up                18                21 
Withdrawal by Subject                4                2 
Other                15                13 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention

Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.

Friend/family member was trained in foot reflexology protocol by certified reflexologist.

Friend/family member provides 4 weekly sessions to patient.

Control Standard medical care: no reflexology.
Total Total of all reporting groups

Baseline Measures
   Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 128   128   256 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.09  (11.62)   54.80  (10.30)   56.44  (11.08) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   128   128   256 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      5   3.9%      6   4.7%      11   4.3% 
Not Hispanic or Latino      123  96.1%      122  95.3%      245  95.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      13  10.2%      13  10.2%      26  10.2% 
White      105  82.0%      107  83.6%      212  82.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      10   7.8%      8   6.3%      18   7.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   128   128   256 


  Outcome Measures
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1.  Primary:   The M.D. Anderson Symptom Inventory (MDASI)   [ Time Frame: Week 5 and week 11 ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gwen Wyatt
Organization: Michigan State University
phone: 517-432-5511
e-mail: gwyatt@msu.edu



Responsible Party: Gwen Wyatt, 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: November 6, 2017