Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Other: Reflexology
Enrollment 256
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

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.

Standard medical care: no reflexology.
Period Title: Overall Study
Started 128 128
Completed 89 91
Not Completed 39 37
Reason Not Completed
Death             2             1
Lost to Follow-up             18             21
Withdrawal by Subject             4             2
Other             15             13
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

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.

Standard medical care: no reflexology. Total of all reporting groups
Overall Number of Baseline Participants 128 128 256
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 128 participants 256 participants
58.09  (11.62) 54.80  (10.30) 56.44  (11.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
Female 128 128 256
Male 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 128 participants 128 participants 256 participants
128 128 256
1.Primary Outcome
Title The M.D. Anderson Symptom Inventory (MDASI)
Hide Description

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.

Time Frame Week 5 and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Patient outcome data collected at week 5 and week 11
Arm/Group Title Week 5 Intervention Group Week 5 Control Group Week 11 Intervention Group Week 11 Control Group
Hide Arm/Group Description:

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.

Standard medical care: no reflexology

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.

Standard medical care: no reflexology
Overall Number of Participants Analyzed 89 91 89 91
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
MDASI summed symptom severity 23.55  (1.52) 29.69  (1.48) 26.28  (1.54) 28.67  (1.52)
MDASI summed symptom interference 11.19  (1.16) 16.04  (1.12) 12.43  (1.17) 14.88  (1.16)
2.Primary Outcome
Title Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0
Hide Description
  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.

Time Frame Week 5 and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Participant outcome data collected at week 5 and week 11
Arm/Group Title Week 5 Intervention Group Week 5 Control Group Week 11 Intervention Group Week 11 Control Group
Hide Arm/Group Description:

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.

Standard medical care: no reflexology.

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.

Standard medical care: no reflexology.
Overall Number of Participants Analyzed 89 91 89 91
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
PROMIS-Physical function subscale 42.06  (0.57) 41.81  (0.55) 42.93  (0.57) 42.80  (0.56)
PROMIS-Social role subscale 47.59  (0.78) 46.86  (0.75) 48.58  (0.79) 45.92  (0.78)
3.Primary Outcome
Title Quality of Life Index (QLI)
Hide Description 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.
Time Frame Week 5 and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Participant outcome data collected at week 5 and week 11
Arm/Group Title Week 5 Intervention Group Week 5 Control Group Week 11 Intervention Group Week 11 Control Group
Hide Arm/Group Description:

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.

Standard medical care: no reflexology.

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.

Standard medical care: no reflexology.
Overall Number of Participants Analyzed 89 91 89 91
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
22.53  (0.29) 21.94  (0.28) 22.69  (0.29) 22.08  (0.29)
4.Primary Outcome
Title Use of Unscheduled Health Service
Hide Description 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.
Time Frame Week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Participant outcome data collected at week 11
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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.

Standard medical care: no reflexology.
Overall Number of Participants Analyzed 89 91
Mean (Standard Deviation)
Unit of Measure: unscheduled visits
Number of emergency room visits 0.27  (0.78) 0.65  (2.85)
Number of urgent care center visits 0.09  (0.33) 0.12  (0.39)
Number of Hospitalizations 0.76  (1.19) 1.05  (0.61)
Time Frame Adverse events were tracked for unexpected foot effect at weeks 1-11
Adverse Event Reporting Description Adverse events were tracked from patient's report of the unexpected foot effect (UFE) which adapted from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) including discomfort, numbness or tingling, discoloration or bruising.
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

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.

Standard medical care: no reflexology
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   2/128 (1.56%)   1/128 (0.78%) 
Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/128 (0.00%)   0/128 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/128 (0.00%)   0/128 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Gwen Wyatt
Organization: Michigan State University
Phone: 517-432-5511
EMail: gwyatt@msu.edu
Layout table for additonal information
Responsible Party: Gwen Wyatt, Michigan State University
ClinicalTrials.gov Identifier: NCT01582971    
Other Study ID Numbers: 1R01CA157459-01 ( U.S. NIH Grant/Contract )
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: April 18, 2018