Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

• 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: Michigan State University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Intervention	Control
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

Baseline Characteristics

Arm/Group Title		Intervention	Control	Total
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
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

Outcome Measures

1. Primary Outcome

Title	The M.D. Anderson Symptom Inventory (MDASI)
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

Outcome Measure Data

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
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
Description	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.; 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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Participant outcome data collected at week 11

Arm/Group Title	Intervention	Control
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)

Adverse Events

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
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%)
Serious Adverse Events
	Intervention	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/128 (0.00%)	0/128 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: gwyatt@msu.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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