Trial Outcomes & Findings for Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients (NCT NCT02759146)
NCT ID: NCT02759146
Last Updated: 2020-12-16
Results Overview
Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
347 participants
Primary outcome timeframe
Week 1 -Week 4
Results posted on
2020-12-16
Participant Flow
Participants were recruited from 8 clinical centers between April 2015 and November 2019.
Of the 471 consented, 347 completed the baseline interview and were randomized. Between the time of consent and baseline interview 124 dyads attrited. Reasons included: Changed mind about participating (n=24), cannot be reached via phone/mail (n=55), too busy (n=19), too overwhelmed (n=8), too sick (n=9) and other reasons (n=48). Throughout the study, if either patient or caregiver dropped from the study, the dyad was considered an attrition.
Participant milestones
| Measure |
Reflexology With Response, Then Continued Reflexology
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Participants were randomized into the reflexology intervention, then after week 4 of symptom responses, were considered responders. Participants then continued with the reflexology intervention.
|
Reflexology Non-responders, Then Continued Reflexology
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Participants were randomized into the reflexology intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then continued with the reflexology intervention.
|
Reflexology Non-responders, Then Switch to Meditation
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.
Participants were randomized into the reflexology intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then switched to a meditative practice intervention.
|
Control
Control - no intervention
|
Meditative Practice With Response, Continued Meditation
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.
Participants were randomized into the meditative practice intervention, then after 4 weeks of symptom response were considered responders. Participants then continued with the meditative practice intervention.
|
Meditative Practice Non-responders, Continued Meditation
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.
Participants were randomized into the mindfulness meditation intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then continued with the meditative practice intervention.
|
Meditative Practice Non-responders, Switch to Reflexology
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Participants were randomized into the meditative practice intervention, then after 4 weeks of symptom responses were considered non-responders. Participants then switched to a reflexology intervention.
|
|---|---|---|---|---|---|---|---|
|
Week 1-4
STARTED
|
57
|
36
|
33
|
44
|
49
|
30
|
27
|
|
Week 1-4
COMPLETED
|
56
|
34
|
32
|
44
|
49
|
29
|
26
|
|
Week 1-4
NOT COMPLETED
|
1
|
2
|
1
|
0
|
0
|
1
|
1
|
|
Week 5-8
STARTED
|
56
|
34
|
32
|
44
|
49
|
29
|
26
|
|
Week 5-8
COMPLETED
|
46
|
29
|
22
|
37
|
44
|
23
|
20
|
|
Week 5-8
NOT COMPLETED
|
10
|
5
|
10
|
7
|
5
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline measure separated by patient/ caregiver
Baseline characteristics by cohort
| Measure |
Reflexology Patients
n=150 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=150 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=47 Participants
Control- no intervention
|
Reflexology Caregivers
n=150 Participants
Caregivers providing reflexology to their friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditation Practice Caregivers
n=150 Participants
Caregivers providing meditative practice to their friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Caregivers
n=47 Participants
Control - no intervention
|
Total
n=694 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age- Caregiver
|
—
|
—
|
—
|
56.07 years
STANDARD_DEVIATION 14.84 • n=146 Participants • Baseline measure separated by patient/ caregiver
|
55.56 years
STANDARD_DEVIATION 14.58 • n=146 Participants • Baseline measure separated by patient/ caregiver
|
54.59 years
STANDARD_DEVIATION 13.42 • n=47 Participants • Baseline measure separated by patient/ caregiver
|
55.65 years
STANDARD_DEVIATION 14.50 • n=339 Participants • Baseline measure separated by patient/ caregiver
|
|
Age, Customized
Age- Patient
|
56.65 years
STANDARD_DEVIATION 13.91 • n=150 Participants • Baseline measure separated by patient/ caregiver
|
58.41 years
STANDARD_DEVIATION 12.29 • n=150 Participants • Baseline measure separated by patient/ caregiver
|
59.31 years
STANDARD_DEVIATION 13.99 • n=47 Participants • Baseline measure separated by patient/ caregiver
|
—
|
—
|
—
|
57.77 years
STANDARD_DEVIATION 13.25 • n=347 Participants • Baseline measure separated by patient/ caregiver
|
|
Sex: Female, Male
Female
|
116 Participants
n=150 Participants • Participant did not respond
|
115 Participants
n=150 Participants • Participant did not respond
|
34 Participants
n=47 Participants • Participant did not respond
|
84 Participants
n=140 Participants • Participant did not respond
|
76 Participants
n=137 Participants • Participant did not respond
|
26 Participants
n=45 Participants • Participant did not respond
|
451 Participants
n=669 Participants • Participant did not respond
|
|
Sex: Female, Male
Male
|
34 Participants
n=150 Participants • Participant did not respond
|
35 Participants
n=150 Participants • Participant did not respond
|
13 Participants
n=47 Participants • Participant did not respond
|
56 Participants
n=140 Participants • Participant did not respond
|
61 Participants
n=137 Participants • Participant did not respond
|
19 Participants
n=45 Participants • Participant did not respond
|
218 Participants
n=669 Participants • Participant did not respond
|
|
Race/Ethnicity, Customized
Race · White Caucasian
|
126 Participants
n=150 Participants • Participant did not respond
|
129 Participants
n=150 Participants • Participant did not respond
|
46 Participants
n=47 Participants • Participant did not respond
|
119 Participants
n=139 Participants • Participant did not respond
|
119 Participants
n=145 Participants • Participant did not respond
|
40 Participants
n=47 Participants • Participant did not respond
|
579 Participants
n=678 Participants • Participant did not respond
|
|
Race/Ethnicity, Customized
Race · Asian
|
7 Participants
n=150 Participants • Participant did not respond
|
2 Participants
n=150 Participants • Participant did not respond
|
1 Participants
n=47 Participants • Participant did not respond
|
4 Participants
n=139 Participants • Participant did not respond
|
5 Participants
n=145 Participants • Participant did not respond
|
4 Participants
n=47 Participants • Participant did not respond
|
23 Participants
n=678 Participants • Participant did not respond
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
12 Participants
n=150 Participants • Participant did not respond
|
12 Participants
n=150 Participants • Participant did not respond
|
0 Participants
n=47 Participants • Participant did not respond
|
8 Participants
n=139 Participants • Participant did not respond
|
12 Participants
n=145 Participants • Participant did not respond
|
0 Participants
n=47 Participants • Participant did not respond
|
44 Participants
n=678 Participants • Participant did not respond
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=150 Participants • Participant did not respond
|
7 Participants
n=150 Participants • Participant did not respond
|
0 Participants
n=47 Participants • Participant did not respond
|
8 Participants
n=139 Participants • Participant did not respond
|
9 Participants
n=145 Participants • Participant did not respond
|
3 Participants
n=47 Participants • Participant did not respond
|
32 Participants
n=678 Participants • Participant did not respond
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
23 Participants
n=147 Participants • Participant did not respond
|
7 Participants
n=148 Participants • Participant did not respond
|
3 Participants
n=46 Participants • Participant did not respond
|
17 Participants
n=145 Participants • Participant did not respond
|
7 Participants
n=147 Participants • Participant did not respond
|
3 Participants
n=47 Participants • Participant did not respond
|
60 Participants
n=680 Participants • Participant did not respond
|
|
Race/Ethnicity, Customized
Ethnicity · Non Hispanic
|
122 Participants
n=147 Participants • Participant did not respond
|
140 Participants
n=148 Participants • Participant did not respond
|
43 Participants
n=46 Participants • Participant did not respond
|
126 Participants
n=145 Participants • Participant did not respond
|
139 Participants
n=147 Participants • Participant did not respond
|
44 Participants
n=47 Participants • Participant did not respond
|
614 Participants
n=680 Participants • Participant did not respond
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
2 Participants
n=147 Participants • Participant did not respond
|
1 Participants
n=148 Participants • Participant did not respond
|
0 Participants
n=46 Participants • Participant did not respond
|
2 Participants
n=145 Participants • Participant did not respond
|
1 Participants
n=147 Participants • Participant did not respond
|
0 Participants
n=47 Participants • Participant did not respond
|
6 Participants
n=680 Participants • Participant did not respond
|
|
Number of comorbid conditions
Comorbid conditions- patient
|
3.89 Number of conditions
STANDARD_DEVIATION 2.83 • n=148 Participants • Not all participants responded to question
|
3.83 Number of conditions
STANDARD_DEVIATION 2.73 • n=148 Participants • Not all participants responded to question
|
4.19 Number of conditions
STANDARD_DEVIATION 3.35 • n=47 Participants • Not all participants responded to question
|
—
|
—
|
—
|
3.90 Number of conditions
STANDARD_DEVIATION 2.86 • n=343 Participants • Not all participants responded to question
|
|
Number of comorbid conditions
Comorbid conditions- caregiver
|
—
|
—
|
—
|
3.45 Number of conditions
STANDARD_DEVIATION 2.56 • n=146 Participants • Not all participants responded to question
|
2.93 Number of conditions
STANDARD_DEVIATION 2.71 • n=148 Participants • Not all participants responded to question
|
3.06 Number of conditions
STANDARD_DEVIATION 2.54 • n=47 Participants • Not all participants responded to question
|
3.17 Number of conditions
STANDARD_DEVIATION 2.63 • n=341 Participants • Not all participants responded to question
|
|
Patient-caregiver relationship
Spouse
|
85 Participants
n=145 Participants • Participant did not respond
|
94 Participants
n=147 Participants • Participant did not respond
|
30 Participants
n=47 Participants • Participant did not respond
|
85 Participants
n=145 Participants • Participant did not respond
|
94 Participants
n=147 Participants • Participant did not respond
|
30 Participants
n=47 Participants • Participant did not respond
|
418 Participants
n=678 Participants • Participant did not respond
|
|
Patient-caregiver relationship
Adult Child
|
14 Participants
n=145 Participants • Participant did not respond
|
11 Participants
n=147 Participants • Participant did not respond
|
3 Participants
n=47 Participants • Participant did not respond
|
15 Participants
n=145 Participants • Participant did not respond
|
16 Participants
n=147 Participants • Participant did not respond
|
7 Participants
n=47 Participants • Participant did not respond
|
66 Participants
n=678 Participants • Participant did not respond
|
|
Patient-caregiver relationship
Parent
|
15 Participants
n=145 Participants • Participant did not respond
|
16 Participants
n=147 Participants • Participant did not respond
|
7 Participants
n=47 Participants • Participant did not respond
|
14 Participants
n=145 Participants • Participant did not respond
|
11 Participants
n=147 Participants • Participant did not respond
|
3 Participants
n=47 Participants • Participant did not respond
|
66 Participants
n=678 Participants • Participant did not respond
|
|
Patient-caregiver relationship
Friend
|
19 Participants
n=145 Participants • Participant did not respond
|
17 Participants
n=147 Participants • Participant did not respond
|
5 Participants
n=47 Participants • Participant did not respond
|
19 Participants
n=145 Participants • Participant did not respond
|
17 Participants
n=147 Participants • Participant did not respond
|
5 Participants
n=47 Participants • Participant did not respond
|
82 Participants
n=678 Participants • Participant did not respond
|
|
Patient-caregiver relationship
Other
|
12 Participants
n=145 Participants • Participant did not respond
|
9 Participants
n=147 Participants • Participant did not respond
|
2 Participants
n=47 Participants • Participant did not respond
|
12 Participants
n=145 Participants • Participant did not respond
|
9 Participants
n=147 Participants • Participant did not respond
|
2 Participants
n=47 Participants • Participant did not respond
|
46 Participants
n=678 Participants • Participant did not respond
|
|
Living arrangement
Together
|
100 Participants
n=142 Participants • Not all patients/ caregivers responded
|
112 Participants
n=147 Participants • Not all patients/ caregivers responded
|
34 Participants
n=47 Participants • Not all patients/ caregivers responded
|
100 Participants
n=142 Participants • Not all patients/ caregivers responded
|
112 Participants
n=147 Participants • Not all patients/ caregivers responded
|
34 Participants
n=47 Participants • Not all patients/ caregivers responded
|
492 Participants
n=672 Participants • Not all patients/ caregivers responded
|
|
Living arrangement
Separately
|
42 Participants
n=142 Participants • Not all patients/ caregivers responded
|
35 Participants
n=147 Participants • Not all patients/ caregivers responded
|
13 Participants
n=47 Participants • Not all patients/ caregivers responded
|
42 Participants
n=142 Participants • Not all patients/ caregivers responded
|
35 Participants
n=147 Participants • Not all patients/ caregivers responded
|
13 Participants
n=47 Participants • Not all patients/ caregivers responded
|
180 Participants
n=672 Participants • Not all patients/ caregivers responded
|
|
Number of Complimentary and Alternative Medicine (CAM) therapies used
|
2.36 Number of CAM therapies
STANDARD_DEVIATION 2.41 • n=148 Participants • Participants did not respond
|
2.51 Number of CAM therapies
STANDARD_DEVIATION 2.23 • n=148 Participants • Participants did not respond
|
2.00 Number of CAM therapies
STANDARD_DEVIATION 1.91 • n=47 Participants • Participants did not respond
|
—
|
—
|
—
|
2.38 Number of CAM therapies
STANDARD_DEVIATION 2.27 • n=343 Participants • Participants did not respond
|
|
Education
High school or less
|
2 Participants
n=150 Participants
|
4 Participants
n=150 Participants
|
0 Participants
n=47 Participants
|
25 Participants
n=150 Participants
|
18 Participants
n=150 Participants
|
6 Participants
n=47 Participants
|
55 Participants
n=694 Participants
|
|
Education
At least some college
|
61 Participants
n=150 Participants
|
62 Participants
n=150 Participants
|
22 Participants
n=47 Participants
|
85 Participants
n=150 Participants
|
81 Participants
n=150 Participants
|
28 Participants
n=47 Participants
|
339 Participants
n=694 Participants
|
|
Education
Graduate/ professional degree
|
45 Participants
n=150 Participants
|
33 Participants
n=150 Participants
|
11 Participants
n=47 Participants
|
36 Participants
n=150 Participants
|
49 Participants
n=150 Participants
|
13 Participants
n=47 Participants
|
187 Participants
n=694 Participants
|
|
Employment
Employed full time
|
46 Participants
n=147 Participants • Participant did not respond
|
44 Participants
n=146 Participants • Participant did not respond
|
13 Participants
n=47 Participants • Participant did not respond
|
78 Participants
n=145 Participants • Participant did not respond
|
67 Participants
n=147 Participants • Participant did not respond
|
18 Participants
n=47 Participants • Participant did not respond
|
266 Participants
n=679 Participants • Participant did not respond
|
|
Employment
Employed part time
|
9 Participants
n=147 Participants • Participant did not respond
|
15 Participants
n=146 Participants • Participant did not respond
|
4 Participants
n=47 Participants • Participant did not respond
|
11 Participants
n=145 Participants • Participant did not respond
|
15 Participants
n=147 Participants • Participant did not respond
|
5 Participants
n=47 Participants • Participant did not respond
|
59 Participants
n=679 Participants • Participant did not respond
|
|
Employment
Retired
|
9 Participants
n=147 Participants • Participant did not respond
|
6 Participants
n=146 Participants • Participant did not respond
|
2 Participants
n=47 Participants • Participant did not respond
|
42 Participants
n=145 Participants • Participant did not respond
|
47 Participants
n=147 Participants • Participant did not respond
|
16 Participants
n=47 Participants • Participant did not respond
|
122 Participants
n=679 Participants • Participant did not respond
|
|
Employment
Not employed
|
83 Participants
n=147 Participants • Participant did not respond
|
81 Participants
n=146 Participants • Participant did not respond
|
28 Participants
n=47 Participants • Participant did not respond
|
14 Participants
n=145 Participants • Participant did not respond
|
18 Participants
n=147 Participants • Participant did not respond
|
8 Participants
n=47 Participants • Participant did not respond
|
232 Participants
n=679 Participants • Participant did not respond
|
|
Income
<= $24,000
|
18 Participants
n=146 Participants • Participant did not respond
|
8 Participants
n=148 Participants • Participant did not respond
|
1 Participants
n=46 Participants • Participant did not respond
|
13 Participants
n=134 Participants • Participant did not respond
|
9 Participants
n=137 Participants • Participant did not respond
|
4 Participants
n=43 Participants • Participant did not respond
|
53 Participants
n=654 Participants • Participant did not respond
|
|
Income
$25,000-$49,000
|
21 Participants
n=146 Participants • Participant did not respond
|
25 Participants
n=148 Participants • Participant did not respond
|
5 Participants
n=46 Participants • Participant did not respond
|
25 Participants
n=134 Participants • Participant did not respond
|
23 Participants
n=137 Participants • Participant did not respond
|
7 Participants
n=43 Participants • Participant did not respond
|
106 Participants
n=654 Participants • Participant did not respond
|
|
Income
$50,000-$99,000
|
30 Participants
n=146 Participants • Participant did not respond
|
28 Participants
n=148 Participants • Participant did not respond
|
7 Participants
n=46 Participants • Participant did not respond
|
32 Participants
n=134 Participants • Participant did not respond
|
42 Participants
n=137 Participants • Participant did not respond
|
6 Participants
n=43 Participants • Participant did not respond
|
145 Participants
n=654 Participants • Participant did not respond
|
|
Income
>=$100,000
|
17 Participants
n=146 Participants • Participant did not respond
|
24 Participants
n=148 Participants • Participant did not respond
|
11 Participants
n=46 Participants • Participant did not respond
|
24 Participants
n=134 Participants • Participant did not respond
|
20 Participants
n=137 Participants • Participant did not respond
|
11 Participants
n=43 Participants • Participant did not respond
|
107 Participants
n=654 Participants • Participant did not respond
|
|
Income
Other
|
60 Participants
n=146 Participants • Participant did not respond
|
63 Participants
n=148 Participants • Participant did not respond
|
22 Participants
n=46 Participants • Participant did not respond
|
40 Participants
n=134 Participants • Participant did not respond
|
43 Participants
n=137 Participants • Participant did not respond
|
15 Participants
n=43 Participants • Participant did not respond
|
243 Participants
n=654 Participants • Participant did not respond
|
|
Brief Fatigue Inventory Severity of Fatigue (BFI, worst fatigue)
|
4.08 units on a scale
STANDARD_DEVIATION 2.90 • n=148 Participants • Caregivers did not report outcome measure
|
3.95 units on a scale
STANDARD_DEVIATION 2.71 • n=148 Participants • Caregivers did not report outcome measure
|
3.81 units on a scale
STANDARD_DEVIATION 2.63 • n=47 Participants • Caregivers did not report outcome measure
|
—
|
—
|
—
|
3.99 units on a scale
STANDARD_DEVIATION 2.78 • n=343 Participants • Caregivers did not report outcome measure
|
|
Fatigue interference (BFI)
|
20.14 units on a scale
STANDARD_DEVIATION 15.09 • n=148 Participants • Caregivers did not report outcome measure
|
21.85 units on a scale
STANDARD_DEVIATION 16.14 • n=148 Participants • Caregivers did not report outcome measure
|
21.91 units on a scale
STANDARD_DEVIATION 14.08 • n=47 Participants • Caregivers did not report outcome measure
|
—
|
—
|
—
|
21.12 units on a scale
STANDARD_DEVIATION 15.40 • n=343 Participants • Caregivers did not report outcome measure
|
|
Summed severity of other symptoms (MDASI)
|
38.61 units on a scale
STANDARD_DEVIATION 29.00 • n=148 Participants • Caregivers did not report outcome measure
|
40.43 units on a scale
STANDARD_DEVIATION 28.24 • n=148 Participants • Caregivers did not report outcome measure
|
37.23 units on a scale
STANDARD_DEVIATION 22.46 • n=47 Participants • Caregivers did not report outcome measure
|
—
|
—
|
—
|
39.20 units on a scale
STANDARD_DEVIATION 27.81 • n=343 Participants • Caregivers did not report outcome measure
|
|
Symptom interference (MDASI)
|
19.06 units on a scale
STANDARD_DEVIATION 15.46 • n=148 Participants • Caregivers did not report outcome measure
|
19.69 units on a scale
STANDARD_DEVIATION 15.35 • n=148 Participants • Caregivers did not report outcome measure
|
18.98 units on a scale
STANDARD_DEVIATION 14.91 • n=47 Participants • Caregivers did not report outcome measure
|
—
|
—
|
—
|
19.32 units on a scale
STANDARD_DEVIATION 15.30 • n=343 Participants • Caregivers did not report outcome measure
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) depression
PROMIS depression- Patient
|
53.67 units on a scale
STANDARD_DEVIATION 8.52 • n=148 Participants • Not all participants responded to question
|
53.13 units on a scale
STANDARD_DEVIATION 8.39 • n=148 Participants • Not all participants responded to question
|
55.26 units on a scale
STANDARD_DEVIATION 7.98 • n=47 Participants • Not all participants responded to question
|
—
|
—
|
—
|
53.65 units on a scale
STANDARD_DEVIATION 8.39 • n=343 Participants • Not all participants responded to question
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) depression
PROMIS depression- Caregiver
|
—
|
—
|
—
|
47.14 units on a scale
STANDARD_DEVIATION 7.61 • n=146 Participants • Not all participants responded to question
|
45.41 units on a scale
STANDARD_DEVIATION 6.45 • n=148 Participants • Not all participants responded to question
|
46.87 units on a scale
STANDARD_DEVIATION 7.82 • n=47 Participants • Not all participants responded to question
|
46.35 units on a scale
STANDARD_DEVIATION 7.19 • n=341 Participants • Not all participants responded to question
|
|
PROMIS anxiety
PROMIS anxiety- Patient
|
54.34 units on a scale
STANDARD_DEVIATION 9.17 • n=148 Participants • Not all participants responded
|
53.64 units on a scale
STANDARD_DEVIATION 8.66 • n=148 Participants • Not all participants responded
|
55.01 units on a scale
STANDARD_DEVIATION 7.78 • n=47 Participants • Not all participants responded
|
—
|
—
|
—
|
54.13 units on a scale
STANDARD_DEVIATION 8.76 • n=343 Participants • Not all participants responded
|
|
PROMIS anxiety
PROMIS anxiety- Caregiver
|
—
|
—
|
—
|
48.38 units on a scale
STANDARD_DEVIATION 8.31 • n=146 Participants • Not all participants responded
|
46.09 units on a scale
STANDARD_DEVIATION 7.67 • n=147 Participants • Not all participants responded
|
48.10 units on a scale
STANDARD_DEVIATION 9.43 • n=47 Participants • Not all participants responded
|
47.35 units on a scale
STANDARD_DEVIATION 8.26 • n=340 Participants • Not all participants responded
|
|
Attentional function index
Subscale 1 (action)
|
6.08 units on a scale
STANDARD_DEVIATION 2.22 • n=148 Participants • Caregivers did not report outcome information
|
6.19 units on a scale
STANDARD_DEVIATION 2.11 • n=148 Participants • Caregivers did not report outcome information
|
5.71 units on a scale
STANDARD_DEVIATION 2.45 • n=47 Participants • Caregivers did not report outcome information
|
—
|
—
|
—
|
6.08 units on a scale
STANDARD_DEVIATION 2.20 • n=343 Participants • Caregivers did not report outcome information
|
|
Attentional function index
Subscale 2 (lapses)
|
3.50 units on a scale
STANDARD_DEVIATION 2.20 • n=148 Participants • Caregivers did not report outcome information
|
3.19 units on a scale
STANDARD_DEVIATION 2.25 • n=148 Participants • Caregivers did not report outcome information
|
3.21 units on a scale
STANDARD_DEVIATION 2.07 • n=47 Participants • Caregivers did not report outcome information
|
—
|
—
|
—
|
3.33 units on a scale
STANDARD_DEVIATION 2.20 • n=343 Participants • Caregivers did not report outcome information
|
|
Attentional function index
Subscale 3 (effectiveness)
|
5.93 units on a scale
STANDARD_DEVIATION 1.71 • n=148 Participants • Caregivers did not report outcome information
|
6.04 units on a scale
STANDARD_DEVIATION 1.67 • n=148 Participants • Caregivers did not report outcome information
|
5.70 units on a scale
STANDARD_DEVIATION 1.93 • n=47 Participants • Caregivers did not report outcome information
|
—
|
—
|
—
|
5.95 units on a scale
STANDARD_DEVIATION 1.73 • n=343 Participants • Caregivers did not report outcome information
|
|
Long Term Quality of Life (LTQL) spirituality
|
34.27 units on a scale
STANDARD_DEVIATION 8.56 • n=148 Participants • Caregivers did not report outcome measure
|
33.63 units on a scale
STANDARD_DEVIATION 7.30 • n=148 Participants • Caregivers did not report outcome measure
|
33.26 units on a scale
STANDARD_DEVIATION 8.33 • n=47 Participants • Caregivers did not report outcome measure
|
—
|
—
|
—
|
33.85 units on a scale
STANDARD_DEVIATION 7.99 • n=343 Participants • Caregivers did not report outcome measure
|
|
Social Support (MSPSS)
|
25.93 units on a scale
STANDARD_DEVIATION 4.46 • n=148 Participants • Caregivers did not report outcome measure
|
26.40 units on a scale
STANDARD_DEVIATION 4.19 • n=148 Participants • Caregivers did not report outcome measure
|
25.64 units on a scale
STANDARD_DEVIATION 3.07 • n=47 Participants • Caregivers did not report outcome measure
|
—
|
—
|
—
|
26.09 units on a scale
STANDARD_DEVIATION 4.18 • n=343 Participants • Caregivers did not report outcome measure
|
|
PROMIS physical function
PROMIS physical function- Patient
|
39.97 units on a scale
STANDARD_DEVIATION 7.99 • n=146 Participants • Not all participants responded to question
|
40.17 units on a scale
STANDARD_DEVIATION 8.58 • n=145 Participants • Not all participants responded to question
|
39.91 units on a scale
STANDARD_DEVIATION 7.01 • n=47 Participants • Not all participants responded to question
|
—
|
—
|
—
|
40.05 units on a scale
STANDARD_DEVIATION 8.10 • n=338 Participants • Not all participants responded to question
|
|
PROMIS physical function
PROMIS physical function- Caregiver
|
—
|
—
|
—
|
54.00 units on a scale
STANDARD_DEVIATION 6.03 • n=145 Participants • Not all participants responded to question
|
53.33 units on a scale
STANDARD_DEVIATION 6.74 • n=148 Participants • Not all participants responded to question
|
52.40 units on a scale
STANDARD_DEVIATION 8.54 • n=46 Participants • Not all participants responded to question
|
53.49 units on a scale
STANDARD_DEVIATION 6.73 • n=339 Participants • Not all participants responded to question
|
|
PROMIS sleep disturbance
|
—
|
—
|
—
|
47.09 units on a scale
STANDARD_DEVIATION 7.18 • n=146 Participants • Patients did not report outcome measure
|
46.29 units on a scale
STANDARD_DEVIATION 8.27 • n=147 Participants • Patients did not report outcome measure
|
47.86 units on a scale
STANDARD_DEVIATION 7.80 • n=47 Participants • Patients did not report outcome measure
|
46.85 units on a scale
STANDARD_DEVIATION 7.75 • n=340 Participants • Patients did not report outcome measure
|
|
PROMIS fatigue
|
—
|
—
|
—
|
47.10 units on a scale
STANDARD_DEVIATION 9.03 • n=146 Participants • Patients did not report outcome measure
|
45.40 units on a scale
STANDARD_DEVIATION 8.57 • n=147 Participants • Patients did not report outcome measure
|
48.43 units on a scale
STANDARD_DEVIATION 9.78 • n=47 Participants • Patients did not report outcome measure
|
46.55 units on a scale
STANDARD_DEVIATION 8.99 • n=340 Participants • Patients did not report outcome measure
|
|
PROMIS pain interference
|
—
|
—
|
—
|
47.59 units on a scale
STANDARD_DEVIATION 7.67 • n=145 Participants • Patients did not report outcome measure
|
47.18 units on a scale
STANDARD_DEVIATION 7.85 • n=147 Participants • Patients did not report outcome measure
|
49.28 units on a scale
STANDARD_DEVIATION 8.75 • n=47 Participants • Patients did not report outcome measure
|
47.65 units on a scale
STANDARD_DEVIATION 7.91 • n=339 Participants • Patients did not report outcome measure
|
|
PROMIS pain intensity
|
—
|
—
|
—
|
1.51 units on a scale
STANDARD_DEVIATION 1.86 • n=145 Participants • Patients did not report outcome measure
|
1.29 units on a scale
STANDARD_DEVIATION 1.84 • n=147 Participants • Patients did not report outcome measure
|
1.64 units on a scale
STANDARD_DEVIATION 1.94 • n=47 Participants • Patients did not report outcome measure
|
1.43 units on a scale
STANDARD_DEVIATION 1.86 • n=339 Participants • Patients did not report outcome measure
|
|
Satisfaction with participation in social roles
|
—
|
—
|
—
|
54.63 units on a scale
STANDARD_DEVIATION 8.69 • n=146 Participants • Patients did not report outcome measure
|
55.94 units on a scale
STANDARD_DEVIATION 7.92 • n=148 Participants • Patients did not report outcome measure
|
53.15 units on a scale
STANDARD_DEVIATION 9.23 • n=47 Participants • Patients did not report outcome measure
|
55.00 units on a scale
STANDARD_DEVIATION 8.47 • n=341 Participants • Patients did not report outcome measure
|
|
Caregiver burden
Subscale 1 (impact)
|
—
|
—
|
—
|
2.46 units on a scale
STANDARD_DEVIATION 0.88 • n=146 Participants • Participant did not respond
|
2.35 units on a scale
STANDARD_DEVIATION 0.90 • n=148 Participants • Participant did not respond
|
2.63 units on a scale
STANDARD_DEVIATION 0.76 • n=47 Participants • Participant did not respond
|
2.44 units on a scale
STANDARD_DEVIATION 0.88 • n=341 Participants • Participant did not respond
|
|
Caregiver burden
Subscale 2 (esteem)
|
—
|
—
|
—
|
4.54 units on a scale
STANDARD_DEVIATION 0.44 • n=146 Participants • Participant did not respond
|
4.54 units on a scale
STANDARD_DEVIATION 0.37 • n=148 Participants • Participant did not respond
|
4.40 units on a scale
STANDARD_DEVIATION 0.46 • n=47 Participants • Participant did not respond
|
4.52 units on a scale
STANDARD_DEVIATION 0.42 • n=341 Participants • Participant did not respond
|
|
Caregiver burden
Subscale 3 (support)
|
—
|
—
|
—
|
1.70 units on a scale
STANDARD_DEVIATION 0.68 • n=146 Participants • Participant did not respond
|
1.67 units on a scale
STANDARD_DEVIATION 0.75 • n=148 Participants • Participant did not respond
|
1.84 units on a scale
STANDARD_DEVIATION 0.66 • n=47 Participants • Participant did not respond
|
1.71 units on a scale
STANDARD_DEVIATION 0.71 • n=341 Participants • Participant did not respond
|
|
Caregiver burden
Subscale 4 (health)
|
—
|
—
|
—
|
1.47 units on a scale
STANDARD_DEVIATION 0.68 • n=146 Participants • Participant did not respond
|
1.40 units on a scale
STANDARD_DEVIATION 0.63 • n=148 Participants • Participant did not respond
|
1.63 units on a scale
STANDARD_DEVIATION 0.75 • n=47 Participants • Participant did not respond
|
1.46 units on a scale
STANDARD_DEVIATION 0.67 • n=341 Participants • Participant did not respond
|
|
Caregiver burden
Subscale 5 (finance)
|
—
|
—
|
—
|
1.95 units on a scale
STANDARD_DEVIATION 0.89 • n=146 Participants • Participant did not respond
|
1.83 units on a scale
STANDARD_DEVIATION 0.84 • n=148 Participants • Participant did not respond
|
1.82 units on a scale
STANDARD_DEVIATION 0.83 • n=47 Participants • Participant did not respond
|
1.88 units on a scale
STANDARD_DEVIATION 0.86 • n=341 Participants • Participant did not respond
|
|
PROMIS- Fatigue Number
|
—
|
—
|
—
|
2.29 units on a scale
STANDARD_DEVIATION 1.07 • n=146 Participants • Only caregivers reported outcome
|
2.02 units on a scale
STANDARD_DEVIATION 1.00 • n=148 Participants • Only caregivers reported outcome
|
2.38 units on a scale
STANDARD_DEVIATION 1.17 • n=47 Participants • Only caregivers reported outcome
|
2.18 units on a scale
STANDARD_DEVIATION 1.06 • n=341 Participants • Only caregivers reported outcome
|
PRIMARY outcome
Timeframe: Week 1 -Week 4Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=120 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=97 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=42 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
Brief Fatigue Inventory (BFI)
|
4.17 units on a scale
Standard Error 0.17
|
4.08 units on a scale
Standard Error 0.18
|
4.32 units on a scale
Standard Error 0.26
|
—
|
PRIMARY outcome
Timeframe: Weeks 1-4Aim 1: Average severity of distress for weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=120 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=97 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=42 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
The MD Anderson Symptom Inventory (MDASI)- Distress
|
2.20 units on a scale
Standard Error 0.17
|
2.21 units on a scale
Standard Error 0.17
|
2.40 units on a scale
Standard Error 0.25
|
—
|
PRIMARY outcome
Timeframe: Weeks 1-4Aim 1: Average severity of symptoms from weeks 1-4 Summed range: 0-180 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=120 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=97 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=42 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
The MD Anderson Symptom Inventory (MDASI)- Summed Severity
|
29.99 units on a scale
Standard Error 1.27
|
29.32 units on a scale
Standard Error 1.30
|
32.52 units on a scale
Standard Error 1.87
|
—
|
PRIMARY outcome
Timeframe: Weeks 1-4Aim 1: Average severity of sadness from weeks 1-4 Score range: 0-10 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=120 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=97 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=42 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
The MD Anderson Symptom Inventory (MDASI)- Sadness
|
1.79 units on a scale
Standard Error 0.15
|
1.78 units on a scale
Standard Error 0.16
|
2.03 units on a scale
Standard Error 0.23
|
—
|
SECONDARY outcome
Timeframe: Weeks 5-12Aims 2 and 3: Average severity of fatigue for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=32 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=36 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=27 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
n=30 Participants
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
Brief Fatigue Inventory (BFI)
|
3.74 units on a scale
Standard Error 0.38
|
3.99 units on a scale
Standard Error 0.35
|
4.52 units on a scale
Standard Error 0.52
|
4.03 units on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Weeks 5-12Aims 2 and 3: Average severity of symptoms for weeks 5-12 Summed range: 0-180 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=27 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=32 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=21 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
n=29 Participants
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
MD Anderson Symptom Inventory (MDASI)- Summed Severity
|
29.96 units on a scale
Standard Error 3.97
|
28.02 units on a scale
Standard Error 3.57
|
32.18 units on a scale
Standard Error 3.76
|
30.33 units on a scale
Standard Error 3.04
|
SECONDARY outcome
Timeframe: Weeks 5-12Aims 2 and 3: Average severity of distress for weeks 5-12 Score range: 0-10 High score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=27 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=32 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=21 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
n=29 Participants
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
MD Anderson Symptom Inventory (MDASI)- Distress
|
2.28 units on a scale
Standard Error 0.33
|
2.09 units on a scale
Standard Error 0.30
|
2.11 units on a scale
Standard Error 0.56
|
2.07 units on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Weeks 5-12Aims 2 and 3: Average severity of sadness for weeks 5-12 Score range: 0-10 High score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=27 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=32 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=21 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
n=29 Participants
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
MD Anderson Symptom Inventory (MDASI)- Sadness
|
2.17 units on a scale
Standard Error 0.40
|
2.03 units on a scale
Standard Error 0.36
|
2.01 units on a scale
Standard Error 0.47
|
2.23 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Weeks 5-12Aim 4: Average severity of fatigue for weeks 5-12 across initial 3 arms of study. The BFI instrument consists of nine items. The first three items ask respondents to rate the severity of fatigue "right now," at its "usual" level during the past 24 hours and at its "worst" level during the past 24 hours. Score range: 0-10 where 0 = no fatigue and 10 = as bad as you can imagine Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=112 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=96 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=43 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
Brief Fatigue Inventory (BFI)
|
3.62 units on a scale
Standard Error 0.21
|
3.53 units on a scale
Standard Error 0.21
|
3.87 units on a scale
Standard Error 0.28
|
—
|
SECONDARY outcome
Timeframe: Weeks 5-12Aim 4: Average severity of distress for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=112 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=96 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=43 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
MD Anderson Symptom Inventory (MDASI)- Distress
|
1.78 units on a scale
Standard Error 0.19
|
2.00 units on a scale
Standard Error 0.20
|
2.20 units on a scale
Standard Error 0.26
|
—
|
SECONDARY outcome
Timeframe: Weeks 5-12Aim 4: Average severity of sadness for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=112 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=96 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=43 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
MD Anderson Symptom Inventory (MDASI)- Sadness
|
1.75 units on a scale
Standard Error 0.18
|
1.66 units on a scale
Standard Error 0.19
|
2.02 units on a scale
Standard Error 0.25
|
—
|
SECONDARY outcome
Timeframe: Weeks 5-12Aim 4: Comparing average severity of symptoms for weeks 5-12 Summed score range: 0-180 Higher score means worse outcome
Outcome measures
| Measure |
Reflexology Patients
n=112 Participants
Patients randomized into the reflexology arm, given reflexology from a friend/ family member.
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
|
Meditative Practice Patients
n=96 Participants
Patients randomized into the meditative practice arm, given meditative practice from a friend/ family member.
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
|
Control Patients
n=43 Participants
Control- no intervention
|
Meditative Practice, Continuing With Meditative Practice
Participants randomized into meditative practice for weeks 1-4, then continued with meditative practice for weeks 5-12
|
|---|---|---|---|---|
|
MD Anderson Symptom Inventory (MDASI)- Summed Severity
|
26.69 units on a scale
Standard Error 1.66
|
25.77 units on a scale
Standard Error 1.70
|
30.25 units on a scale
Standard Error 2.28
|
—
|
Adverse Events
Reflexology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Meditative Practice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place