Trial Outcomes & Findings for Home-Based Symptom Management Via Reflexology for Breast Cancer Patients (NCT NCT01582971)

Last Updated: 2018-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

256 participants

Primary outcome timeframe

Week 5 and week 11

Results posted on

2018-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	128	128
Overall Study COMPLETED	89	91
Overall Study NOT COMPLETED	39	37

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	2	1
Overall Study Lost to Follow-up	18	21
Overall Study Withdrawal by Subject	4	2
Overall Study Other	15	13

Baseline Characteristics

Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=128 Participants 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 n=128 Participants Standard medical care: no reflexology.	Total n=256 Participants Total of all reporting groups
Age, Continuous	58.09 years STANDARD_DEVIATION 11.62 • n=5 Participants	54.80 years STANDARD_DEVIATION 10.30 • n=7 Participants	56.44 years STANDARD_DEVIATION 11.08 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	128 Participants n=7 Participants	256 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants	122 Participants n=7 Participants	245 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	105 Participants n=5 Participants	107 Participants n=7 Participants	212 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	128 Participants n=5 Participants	128 Participants n=7 Participants	256 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 5 and week 11

Population: Patient outcome data collected at week 5 and week 11

Outcome measures

Outcome measures
Measure	Week 5 Intervention Group n=89 Participants 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.	Week 5 Control Group n=91 Participants Standard medical care: no reflexology	Week 11 Intervention Group n=89 Participants 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.	Week 11 Control Group n=91 Participants Standard medical care: no reflexology
The M.D. Anderson Symptom Inventory (MDASI) MDASI summed symptom severity	23.55 units on a scale Standard Error 1.52	29.69 units on a scale Standard Error 1.48	26.28 units on a scale Standard Error 1.54	28.67 units on a scale Standard Error 1.52
The M.D. Anderson Symptom Inventory (MDASI) MDASI summed symptom interference	11.19 units on a scale Standard Error 1.16	16.04 units on a scale Standard Error 1.12	12.43 units on a scale Standard Error 1.17	14.88 units on a scale Standard Error 1.16

PRIMARY outcome

Timeframe: Week 5 and week 11

Population: Participant outcome data collected at 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.

Outcome measures

Outcome measures
Measure	Week 5 Intervention Group n=89 Participants 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.	Week 5 Control Group n=91 Participants Standard medical care: no reflexology	Week 11 Intervention Group n=89 Participants 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.	Week 11 Control Group n=91 Participants Standard medical care: no reflexology
Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 PROMIS-Physical function subscale	42.06 units on a scale Standard Error 0.57	41.81 units on a scale Standard Error 0.55	42.93 units on a scale Standard Error 0.57	42.80 units on a scale Standard Error 0.56
Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 PROMIS-Social role subscale	47.59 units on a scale Standard Error 0.78	46.86 units on a scale Standard Error 0.75	48.58 units on a scale Standard Error 0.79	45.92 units on a scale Standard Error 0.78

PRIMARY outcome

Timeframe: Week 5 and week 11

Population: Participant outcome data collected at 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.

Outcome measures

Outcome measures
Measure	Week 5 Intervention Group n=89 Participants 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.	Week 5 Control Group n=91 Participants Standard medical care: no reflexology	Week 11 Intervention Group n=89 Participants 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.	Week 11 Control Group n=91 Participants Standard medical care: no reflexology
Quality of Life Index (QLI)	22.53 units on a scale Standard Error 0.29	21.94 units on a scale Standard Error 0.28	22.69 units on a scale Standard Error 0.29	22.08 units on a scale Standard Error 0.29

PRIMARY outcome

Timeframe: Week 11

Population: Participant outcome data collected at 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.

Outcome measures

Outcome measures
Measure	Week 5 Intervention Group n=89 Participants 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.	Week 5 Control Group n=91 Participants Standard medical care: no reflexology	Week 11 Intervention Group 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.	Week 11 Control Group Standard medical care: no reflexology
Use of Unscheduled Health Service Number of emergency room visits	0.27 unscheduled visits Standard Deviation 0.78	0.65 unscheduled visits Standard Deviation 2.85	—	—
Use of Unscheduled Health Service Number of urgent care center visits	0.09 unscheduled visits Standard Deviation 0.33	0.12 unscheduled visits Standard Deviation 0.39	—	—
Use of Unscheduled Health Service Number of Hospitalizations	0.76 unscheduled visits Standard Deviation 1.19	1.05 unscheduled visits Standard Deviation 0.61	—	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gwen Wyatt

Michigan State University

Phone: 517-432-5511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place