Trial Outcomes & Findings for Mindfulness Therapy for Individuals With Lung Cancer (NCT NCT01565980)
NCT ID: NCT01565980
Last Updated: 2014-11-17
Results Overview
Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine." The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely"). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed.
COMPLETED
NA
40 participants
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
2014-11-17
Participant Flow
Patients were recruited from two community-based hospital sites and one cancer center located in Chicago Illinois. Recruitment occurred between March 2012 to February 2013.
There were no participants excluded from the trial before group assignment. However, there were patients who dropped from the study before starting the intervention.
Participant milestones
| Measure |
Symptom Assessment
weekly phone calls.
symptom assessment: attention control group
|
Mindfulness Intervention
Participants will receive 6 weeks of home-based mindfulness intervention.
Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.
Participants also receive weekly symptom assessment phone interview.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Symptom Assessment
weekly phone calls.
symptom assessment: attention control group
|
Mindfulness Intervention
Participants will receive 6 weeks of home-based mindfulness intervention.
Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.
Participants also receive weekly symptom assessment phone interview.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
health complications
|
1
|
1
|
|
Overall Study
stopped medical treatment
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Mindfulness Therapy for Individuals With Lung Cancer
Baseline characteristics by cohort
| Measure |
Attention Control
n=20 Participants
weekly symptom assessment phone calls.
|
Mindfulness Intervention
n=20 Participants
Participants receive weekly symptom assessment phone calls.
Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
64.5 years
STANDARD_DEVIATION 9.25 • n=4 Participants
|
66.2 years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.Population: Adjusted means of outcomes and their standard errors are reported for times 2 and 3. The summary of linear mixed effects for group comparisons are then presented.
Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine." The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely"). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed.
Outcome measures
| Measure |
Attention Control Group
n=16 Participants
weekly phone calls.
symptom assessment interview.
|
Mindfulness Intervention
n=16 Participants
Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms.
|
|---|---|---|
|
M.D. Anderson Symptom Inventory (MDASI)
Symptom Severity - Time 2
|
33.91 units on a scale
Standard Error 3.94
|
20.91 units on a scale
Standard Error 4.30
|
|
M.D. Anderson Symptom Inventory (MDASI)
Symptom Severity - Time 3
|
33.04 units on a scale
Standard Error 3.98
|
22.86 units on a scale
Standard Error 4.33
|
|
M.D. Anderson Symptom Inventory (MDASI)
Symptom Severity - Summary
|
32.11 units on a scale
Standard Error 2.64
|
26.79 units on a scale
Standard Error 2.84
|
|
M.D. Anderson Symptom Inventory (MDASI)
Symptom Interference - Time 2
|
22.38 units on a scale
Standard Error 2.63
|
10.45 units on a scale
Standard Error 2.88
|
|
M.D. Anderson Symptom Inventory (MDASI)
Symptom Interference - Time 3
|
19.27 units on a scale
Standard Error 2.65
|
11.06 units on a scale
Standard Error 2.90
|
|
M.D. Anderson Symptom Inventory (MDASI)
Symptom Interference - Summary
|
18.95 units on a scale
Standard Error 1.74
|
4.33 units on a scale
Standard Error 1.87
|
PRIMARY outcome
Timeframe: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.Population: Adjusted means of outcomes and standards error provided for T2 \& 3, folllowed by summary of linear mixed effects models for the outcomes for group comparisons.
Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range). With normed scoring, general population has mean=50, SD=10. For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.
Outcome measures
| Measure |
Attention Control Group
n=16 Participants
weekly phone calls.
symptom assessment interview.
|
Mindfulness Intervention
n=16 Participants
Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms.
|
|---|---|---|
|
SF-36
Social Function - Time 3
|
42.53 units on a scale
Standard Error 2.28
|
48.97 units on a scale
Standard Error 2.38
|
|
SF-36
Social Function - Summary
|
41.20 units on a scale
Standard Error 1.75
|
48.25 units on a scale
Standard Error 1.86
|
|
SF-36
Emotional Role Function - Time 2
|
49.28 units on a scale
Standard Error 1.78
|
51.15 units on a scale
Standard Error 1.93
|
|
SF-36
Emotional Role Function - Time 3
|
49.49 units on a scale
Standard Error 1.82
|
51.40 units on a scale
Standard Error 1.94
|
|
SF-36
Emotional Role Function - Summary
|
49.38 units on a scale
Standard Error 1.68
|
51.28 units on a scale
Standard Error 1.82
|
|
SF-36
Mental Health - Time 2
|
49.61 units on a scale
Standard Error 2.20
|
54.51 units on a scale
Standard Error 2.35
|
|
SF-36
Mental Health - Time 3
|
48.30 units on a scale
Standard Error 2.22
|
54.51 units on a scale
Standard Error 2.35
|
|
SF-36
Mental Health - Summary
|
48.97 units on a scale
Standard Error 2.09
|
54.52 units on a scale
Standard Error 2.23
|
|
SF-36
Physical Overall - Time 2
|
37.14 units on a scale
Standard Error 2.05
|
42.79 units on a scale
Standard Error 2.16
|
|
SF-36
Physical Overall - Time 3
|
38.29 units on a scale
Standard Error 2.05
|
41.66 units on a scale
Standard Error 2.16
|
|
SF-36
Physical Overall - Summary
|
37.72 units on a scale
Standard Error 1.84
|
42.22 units on a scale
Standard Error 1.96
|
|
SF-36
Mental Overall - Time 2
|
50.72 units on a scale
Standard Error 2.16
|
54.27 units on a scale
Standard Error 2.29
|
|
SF-36
Mental Overall - Time 3
|
49.84 units on a scale
Standard Error 2.14
|
54.94 units on a scale
Standard Error 2.29
|
|
SF-36
Physical Function -Time 2
|
34.94 units on a scale
Standard Error 1.94
|
42.49 units on a scale
Standard Error 2.02
|
|
SF-36
Physical Function - Time 3
|
36.86 units on a scale
Standard Error 1.94
|
43.31 units on a scale
Standard Error 2.02
|
|
SF-36
Physical Function - Summary
|
35.90 units on a scale
Standard Error 1.73
|
42.90 units on a scale
Standard Error 1.82
|
|
SF-36
Physical Role Function - Time 2
|
39.56 units on a scale
Standard Error 2.22
|
41.61 units on a scale
Standard Error 2.37
|
|
SF-36
Physical Role Function - Time 3
|
41.82 units on a scale
Standard Error 2.27
|
44.34 units on a scale
Standard Error 2.37
|
|
SF-36
Physical Role Function - Summary
|
40.69 units on a scale
Standard Error 1.80
|
42.97 units on a scale
Standard Error 1.91
|
|
SF-36
Bodily Pain Time 2
|
44.81 units on a scale
Standard Error 2.52
|
51.22 units on a scale
Standard Error 2.67
|
|
SF-36
Bodily Pain Time 3
|
45.15 units on a scale
Standard Error 2.56
|
46.58 units on a scale
Standard Error 2.69
|
|
SF-36
Bodily Pain Summary
|
44.93 units on a scale
Standard Error 2.25
|
48.89 units on a scale
Standard Error 2.39
|
|
SF-36
General Health - Time 2
|
46.05 units on a scale
Standard Error 1.90
|
48.20 units on a scale
Standard Error 2.04
|
|
SF-36
General Health Summary
|
44.59 units on a scale
Standard Error 1.70
|
46.35 units on a scale
Standard Error 1.82
|
|
SF-36
Vitality Time 2
|
44.88 units on a scale
Standard Error 2.19
|
47.49 units on a scale
Standard Error 2.34
|
|
SF-36
Vitality Time 3
|
43.37 units on a scale
Standard Error 2.21
|
48.34 units on a scale
Standard Error 2.34
|
|
SF-36
Vitality Summary
|
44.15 units on a scale
Standard Error 2.06
|
47.92 units on a scale
Standard Error 2.19
|
|
SF-36
Social Function - Time 2
|
39.88 units on a scale
Standard Error 2.22
|
47.54 units on a scale
Standard Error 2.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.The score is the sum of the 20 questions. Each item has a range of 1 - 4 for frequency of a behavior or mental state in the past week ; 1 - Rarely or none of the time (less than 1 day); 2 = Some or a little of the time (1-2 days); 3 = Occasionally or a moderate amount of time (3-4 days); 4 = Most or all of the time (5-7 days). Possible range is 0-60. There are 4 reverse-scored items (questions 4, 8, 12, and 16). A score of 16 points or more is considered depressed.
Outcome measures
| Measure |
Attention Control Group
n=16 Participants
weekly phone calls.
symptom assessment interview.
|
Mindfulness Intervention
n=16 Participants
Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms.
|
|---|---|---|
|
Center for Epidemiologic Studies Depression (CES-D)
CESD - Time 2
|
12.70 units on a scale
Standard Error 1.84
|
8.07 units on a scale
Standard Error 1.97
|
|
Center for Epidemiologic Studies Depression (CES-D)
CESD - Time 3
|
12.83 units on a scale
Standard Error 1.84
|
7.63 units on a scale
Standard Error 1.97
|
|
Center for Epidemiologic Studies Depression (CES-D)
CESD - Summary
|
12.76 units on a scale
Standard Error 1.68
|
7.84 units on a scale
Standard Error 1.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.The cancer dyspnea scale (CDS) has 12 Likert scale items ( 1 = Not at all, 5 = Very much) that ask questions about breathlessness or difficulty in breathing during the past few days. The CDS has an overall score (range 0-42) and 3 subscales that measure the amount of effort with breathing, anxiety associated with breathing, and discomfort associated with breathing. The 3 subscales are calculated by: 1) effort (items 4+6+8+10+12) - 5 \[range 0 (no dyspnea effort)-20 (worst dyspnea effort)\]; 2) anxiety (items 5+7+9+11) - 4 \[range 0 (no dyspnea anxiety) - 16 (worst dyspnea anxiety)\]; 3) discomfort \[15 - (items 1+2+3) {range 0 (no dyspnea discomfort) - 12 (worst dyspnea discomfort)}\]. The total dyspnea score is derived by adding the total subscale scores. The subscale score subtractions are to make adjustments for 0 as a state of absence of dyspnea (thus total dyspnea summary scores range from 0 to 42).
Outcome measures
| Measure |
Attention Control Group
n=16 Participants
weekly phone calls.
symptom assessment interview.
|
Mindfulness Intervention
n=16 Participants
Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms.
|
|---|---|---|
|
Cancer Dyspnea Scale
CDS total score - Time 2
|
7.69 units on a scale
Standard Error 1.10
|
4.07 units on a scale
Standard Error 1.19
|
|
Cancer Dyspnea Scale
CDS total score - Time 3
|
7.50 units on a scale
Standard Error 1.10
|
3.21 units on a scale
Standard Error 1.19
|
|
Cancer Dyspnea Scale
CDS - total score - Summary
|
7.60 units on a scale
Standard Error .99
|
3.64 units on a scale
Standard Error 1.07
|
|
Cancer Dyspnea Scale
CDS - effort - Time 2
|
4.25 units on a scale
Standard Error .54
|
2.06 units on a scale
Standard Error .58
|
|
Cancer Dyspnea Scale
CDS - effort - Time 3
|
4.44 units on a scale
Standard Error .54
|
2.14 units on a scale
Standard Error .59
|
|
Cancer Dyspnea Scale
CDS - effort - summary
|
4.34 units on a scale
Standard Error .50
|
2.10 units on a scale
Standard Error .54
|
|
Cancer Dyspnea Scale
CDS - anxiety - Time 2
|
.93 units on a scale
Standard Error .40
|
.79 units on a scale
Standard Error .43
|
|
Cancer Dyspnea Scale
CDS - anxiety - Time 3
|
.80 units on a scale
Standard Error .40
|
.58 units on a scale
Standard Error .43
|
|
Cancer Dyspnea Scale
CDS - anxiety - summary
|
.87 units on a scale
Standard Error .32
|
.69 units on a scale
Standard Error .34
|
|
Cancer Dyspnea Scale
CDS - discomfort - Time 2
|
2.80 units on a scale
Standard Error .56
|
.87 units on a scale
Standard Error .60
|
|
Cancer Dyspnea Scale
CDS - discomfort - Time 3
|
2.55 units on a scale
Standard Error .56
|
.16 units on a scale
Standard Error .60
|
|
Cancer Dyspnea Scale
CDS - discomfort - summary
|
2.68 units on a scale
Standard Error .48
|
.51 units on a scale
Standard Error .52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.Both cancer-related and general worry were measured with 3 item scales. Cancer-related worry had three statements asking about level of worry related to diagnosis, treatment, and worry interference using a 1 = "not at all" to 5 = "most or all the time" scale, range 3-15. Items are summed. General worry used an abbreviated brief Penn State Worry questionnaire with 3 statements that measure how typical that statements are in describing the person. Uses a 3 item scale with 1 = "not at all typical" to 5 = "very typical". the range is 3-15. Items are summed.
Outcome measures
| Measure |
Attention Control Group
n=16 Participants
weekly phone calls.
symptom assessment interview.
|
Mindfulness Intervention
n=16 Participants
Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms.
|
|---|---|---|
|
Worry (Cancer-related and General)
Cancer-related worry - Time 2
|
8.26 units on a scale
Standard Error .58
|
6.28 units on a scale
Standard Error .62
|
|
Worry (Cancer-related and General)
Cancer-related worry - Time 3
|
7.88 units on a scale
Standard Error .58
|
6.06 units on a scale
Standard Error .62
|
|
Worry (Cancer-related and General)
Cancer-related worry - Summary
|
8.07 units on a scale
Standard Error .49
|
6.17 units on a scale
Standard Error .53
|
|
Worry (Cancer-related and General)
General worry - Time 2
|
5.89 units on a scale
Standard Error .52
|
5.41 units on a scale
Standard Error .56
|
|
Worry (Cancer-related and General)
General worry - Time 3
|
7.88 units on a scale
Standard Error .58
|
6.06 units on a scale
Standard Error .62
|
|
Worry (Cancer-related and General)
General worry - Summary
|
8.07 units on a scale
Standard Error .49
|
6.17 units on a scale
Standard Error .53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.The PSSQ\_I has 13 self rated questions. The first 5 items, used to determine sleep quality (presence; frequency of insomnia problems) are rated \[0 = never to 5 = always, 5-7 days per week; (range 0-25)\] and items 6 to 13 are aimed at identifying the degree of interference experienced from sleep impairment (rated 0=not at all to 4=extremely on Likert scale; range 0 - 32).
Outcome measures
| Measure |
Attention Control Group
n=16 Participants
weekly phone calls.
symptom assessment interview.
|
Mindfulness Intervention
n=16 Participants
Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms.
|
|---|---|---|
|
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
PSSQ_I Quality -Time 2
|
10.62 units on a scale
Standard Error 1.95
|
8.71 units on a scale
Standard Error 2.14
|
|
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
PSSQ_I Quality-Time 3
|
12.93 units on a scale
Standard Error 1.99
|
8.17 units on a scale
Standard Error 2.08
|
|
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
PSSQ_I Quality- Overall
|
11.76 units on a scale
Standard Error 1.75
|
8.38 units on a scale
Standard Error 1.87
|
|
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
PSSQ_I Interference- Time 2
|
6.45 units on a scale
Standard Error 1.47
|
5.99 units on a scale
Standard Error 1.55
|
|
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
PSSQ_I Interference- Time 3
|
9.26 units on a scale
Standard Error 1.54
|
6.28 units on a scale
Standard Error 1.55
|
|
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
PSSQ_I Interference- Overall
|
7.80 units on a scale
Standard Error 1.25
|
6.13 units on a scale
Standard Error 1.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline.Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.
Outcome measures
| Measure |
Attention Control Group
n=16 Participants
weekly phone calls.
symptom assessment interview.
|
Mindfulness Intervention
n=16 Participants
Participants receive 6 weekly sessions of a home delivered mindfulness intervention.
Participants receive weekly phone calls to assess symptoms.
|
|---|---|---|
|
Baseline Values for All Measures.
PSSQ_I Sleep interference (range 0-32)
|
6.37 units on a scale
Standard Deviation 6.18
|
10.63 units on a scale
Standard Deviation 8.05
|
|
Baseline Values for All Measures.
MDASI Symptom Severity (range 0-130)
|
29.25 units on a scale
Standard Deviation 19.18
|
35 units on a scale
Standard Deviation 21.26
|
|
Baseline Values for All Measures.
MDASI Symptom Interference (range 0-50)
|
19.15 units on a scale
Standard Deviation 16.41
|
21.25 units on a scale
Standard Deviation 16.2
|
|
Baseline Values for All Measures.
HRQOL -Physical Function (range 0-100)
|
35.25 units on a scale
Standard Deviation 10.17
|
37.73 units on a scale
Standard Deviation 8.90
|
|
Baseline Values for All Measures.
HRQOL - Physical Role Function (range 0-100)
|
40.31 units on a scale
Standard Deviation 10.47
|
38.97 units on a scale
Standard Deviation 9.64
|
|
Baseline Values for All Measures.
HRQOL - Bodily Pain (range 0-100)
|
47.36 units on a scale
Standard Deviation 12.29
|
41.96 units on a scale
Standard Deviation 9.59
|
|
Baseline Values for All Measures.
HRQOL - General Health (range 0-100)
|
46.43 units on a scale
Standard Deviation 11.66
|
41.89 units on a scale
Standard Deviation 11.60
|
|
Baseline Values for All Measures.
HRQOL - Vitality (range 0-100)
|
45.91 units on a scale
Standard Deviation 11.96
|
42.2 units on a scale
Standard Deviation 7.5
|
|
Baseline Values for All Measures.
HRQOL - Social Function (range 0-100)
|
47.56 units on a scale
Standard Deviation 10.72
|
41.55 units on a scale
Standard Deviation 11.42
|
|
Baseline Values for All Measures.
HRQOL - Emotional Function(range 0-100)
|
47.12 units on a scale
Standard Deviation 12.75
|
46.77 units on a scale
Standard Deviation 11.25
|
|
Baseline Values for All Measures.
HRQOL - Mental Health (range 0-100)
|
49.56 units on a scale
Standard Deviation 10.13
|
45.37 units on a scale
Standard Deviation 10.07
|
|
Baseline Values for All Measures.
HRQOL - Physical Summary (range 0-100)
|
39.17 units on a scale
Standard Deviation 10.43
|
37.83 units on a scale
Standard Deviation 8.91
|
|
Baseline Values for All Measures.
HRQOL - Mental Summary (range 0-100)
|
51.82 units on a scale
Standard Deviation 12.23
|
47.33 units on a scale
Standard Deviation 11.01
|
|
Baseline Values for All Measures.
CESD - Depression (range 0-60)
|
10.35 units on a scale
Standard Deviation 8.27
|
15.9 units on a scale
Standard Deviation 10.51
|
|
Baseline Values for All Measures.
CDS - Overall Dyspnea (range 0-42)
|
8.85 units on a scale
Standard Deviation 8.86
|
7.05 units on a scale
Standard Deviation 6.23
|
|
Baseline Values for All Measures.
CDS - Effort (range 0-20)
|
4.85 units on a scale
Standard Deviation 4.98
|
4.45 units on a scale
Standard Deviation 4.47
|
|
Baseline Values for All Measures.
CDS - Anxiety (range 0-16)
|
1.55 units on a scale
Standard Deviation 2.72
|
.85 units on a scale
Standard Deviation 1.5
|
|
Baseline Values for All Measures.
CDS - Discomfort (range 0-12)
|
2.45 units on a scale
Standard Deviation 2.63
|
1.75 units on a scale
Standard Deviation 1.97
|
|
Baseline Values for All Measures.
Worry - General (range 3-15)
|
5.55 units on a scale
Standard Deviation 3.09
|
7.35 units on a scale
Standard Deviation 4.07
|
|
Baseline Values for All Measures.
Worry - Cancer-related (range 3-15)
|
7.45 units on a scale
Standard Deviation 3.63
|
9.70 units on a scale
Standard Deviation 3.57
|
|
Baseline Values for All Measures.
PSSQ_I Sleep quality (range 0-25)
|
11.65 units on a scale
Standard Deviation 7.53
|
14.47 units on a scale
Standard Deviation 6.84
|
Adverse Events
Symptom Assessment
Mindfulness Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca H. Lehto, PhD, Assistant Professor
Michigan State University College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place