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Mindfulness Therapy for Individuals With Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565980
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Rebecca Lehto, Michigan State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Lung Cancer
Interventions Behavioral: symptom assessment
Behavioral: Mindfulness Intervention
Enrollment 40
Recruitment Details 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.
Pre-assignment Details There were no participants excluded from the trial before group assignment. However, there were patients who dropped from the study before starting the intervention.
Arm/Group Title Symptom Assessment Mindfulness Intervention
Hide Arm/Group Description

weekly phone calls.

symptom assessment: attention control group

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.

Period Title: Overall Study
Started 20 20 [1]
Completed 16 16
Not Completed 4 4
Reason Not Completed
Death             1             0
Lost to Follow-up             1             0
health complications             1             1
stopped medical treatment             1             0
Withdrawal by Subject             0             3
[1]
Three patients had started the intervention protocol at the time of study withdrawal.
Arm/Group Title Attention Control Mindfulness Intervention Total
Hide Arm/Group Description weekly symptom assessment phone calls.

Participants receive weekly symptom assessment phone calls.

Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
67.9  (9.5) 64.5  (9.25) 66.2  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
14
  70.0%
13
  65.0%
27
  67.5%
Male
6
  30.0%
7
  35.0%
13
  32.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
3
  15.0%
0
   0.0%
3
   7.5%
Not Hispanic or Latino
17
  85.0%
19
  95.0%
36
  90.0%
Unknown or Not Reported
0
   0.0%
1
   5.0%
1
   2.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
1
   5.0%
0
   0.0%
1
   2.5%
Asian
1
   5.0%
1
   5.0%
2
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.0%
0
   0.0%
1
   2.5%
White
16
  80.0%
18
  90.0%
34
  85.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.0%
1
   5.0%
2
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title M.D. Anderson Symptom Inventory (MDASI)
Hide Description 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.
Time Frame Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Attention Control Group Mindfulness Intervention
Hide Arm/Group Description:

weekly phone calls.

symptom assessment interview.

Participants receive 6 weekly sessions of a home delivered mindfulness intervention.

Participants receive weekly phone calls to assess symptoms.

Overall Number of Participants Analyzed 16 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Symptom Severity - Time 2 33.91  (3.94) 20.91  (4.30)
Symptom Severity - Time 3 33.04  (3.98) 22.86  (4.33)
Symptom Severity - Summary 32.11  (2.64) 26.79  (2.84)
Symptom Interference - Time 2 22.38  (2.63) 10.45  (2.88)
Symptom Interference - Time 3 19.27  (2.65) 11.06  (2.90)
Symptom Interference - Summary 18.95  (1.74) 4.33  (1.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Attention Control Group, Mindfulness Intervention
Comments The outcome measure was analyzed using linear mixed effects models (LME). The main effect of the trial arm was evaluated by averaging time 2 and time 3 values of the outcomes within the LME model. The resulting least square (LS) means and their standard errors are reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments P-values for the comparison of least square (LS) means represent the effect of the trial arm. The effect sizes are calculated as Cohen's d: difference between LS means divided by the standard deviation.
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title SF-36
Hide Description 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.
Time Frame Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Attention Control Group Mindfulness Intervention
Hide Arm/Group Description:

weekly phone calls.

symptom assessment interview.

Participants receive 6 weekly sessions of a home delivered mindfulness intervention.

Participants receive weekly phone calls to assess symptoms.

Overall Number of Participants Analyzed 16 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Function -Time 2 34.94  (1.94) 42.49  (2.02)
Physical Function - Time 3 36.86  (1.94) 43.31  (2.02)
Physical Function - Summary 35.90  (1.73) 42.90  (1.82)
Physical Role Function - Time 2 39.56  (2.22) 41.61  (2.37)
Physical Role Function - Time 3 41.82  (2.27) 44.34  (2.37)
Physical Role Function - Summary 40.69  (1.80) 42.97  (1.91)
Bodily Pain Time 2 44.81  (2.52) 51.22  (2.67)
Bodily Pain Time 3 45.15  (2.56) 46.58  (2.69)
Bodily Pain Summary 44.93  (2.25) 48.89  (2.39)
General Health - Time 2 46.05  (1.90) 48.20  (2.04)
General Health Summary 44.59  (1.70) 46.35  (1.82)
Vitality Time 2 44.88  (2.19) 47.49  (2.34)
Vitality Time 3 43.37  (2.21) 48.34  (2.34)
Vitality Summary 44.15  (2.06) 47.92  (2.19)
Social Function - Time 2 39.88  (2.22) 47.54  (2.38)
Social Function - Time 3 42.53  (2.28) 48.97  (2.38)
Social Function - Summary 41.20  (1.75) 48.25  (1.86)
Emotional Role Function - Time 2 49.28  (1.78) 51.15  (1.93)
Emotional Role Function - Time 3 49.49  (1.82) 51.40  (1.94)
Emotional Role Function - Summary 49.38  (1.68) 51.28  (1.82)
Mental Health - Time 2 49.61  (2.20) 54.51  (2.35)
Mental Health - Time 3 48.30  (2.22) 54.51  (2.35)
Mental Health - Summary 48.97  (2.09) 54.52  (2.23)
Physical Overall - Time 2 37.14  (2.05) 42.79  (2.16)
Physical Overall - Time 3 38.29  (2.05) 41.66  (2.16)
Physical Overall - Summary 37.72  (1.84) 42.22  (1.96)
Mental Overall - Time 2 50.72  (2.16) 54.27  (2.29)
Mental Overall - Time 3 49.84  (2.14) 54.94  (2.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Attention Control Group, Mindfulness Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments P values below 0.05 are considered statistically significant in this study.
Method Mixed Models Analysis
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Center for Epidemiologic Studies Depression (CES-D)
Hide Description 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.
Time Frame Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Attention Control Group Mindfulness Intervention
Hide Arm/Group Description:

weekly phone calls.

symptom assessment interview.

Participants receive 6 weekly sessions of a home delivered mindfulness intervention.

Participants receive weekly phone calls to assess symptoms.

Overall Number of Participants Analyzed 16 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
CESD - Time 2 12.70  (1.84) 8.07  (1.97)
CESD - Time 3 12.83  (1.84) 7.63  (1.97)
CESD - Summary 12.76  (1.68) 7.84  (1.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Attention Control Group, Mindfulness Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments P values below 0.05 are considered statistically significant in this study.
Method Mixed Models Analysis
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Cancer Dyspnea Scale
Hide Description

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).

Time Frame Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Attention Control Group Mindfulness Intervention
Hide Arm/Group Description:

weekly phone calls.

symptom assessment interview.

Participants receive 6 weekly sessions of a home delivered mindfulness intervention.

Participants receive weekly phone calls to assess symptoms.

Overall Number of Participants Analyzed 16 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
CDS total score - Time 2 7.69  (1.10) 4.07  (1.19)
CDS total score - Time 3 7.50  (1.10) 3.21  (1.19)
CDS - total score - Summary 7.60  (.99) 3.64  (1.07)
CDS - effort - Time 2 4.25  (.54) 2.06  (.58)
CDS - effort - Time 3 4.44  (.54) 2.14  (.59)
CDS - effort - summary 4.34  (.50) 2.10  (.54)
CDS - anxiety - Time 2 .93  (.40) .79  (.43)
CDS - anxiety - Time 3 .80  (.40) .58  (.43)
CDS - anxiety - summary .87  (.32) .69  (.34)
CDS - discomfort - Time 2 2.80  (.56) .87  (.60)
CDS - discomfort - Time 3 2.55  (.56) .16  (.60)
CDS - discomfort - summary 2.68  (.48) .51  (.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Attention Control Group, Mindfulness Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments P values below 0.05 are considered statistically significant in this study.
Method Mixed Models Analysis
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Worry (Cancer-related and General)
Hide Description 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.
Time Frame Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Attention Control Group Mindfulness Intervention
Hide Arm/Group Description:

weekly phone calls.

symptom assessment interview.

Participants receive 6 weekly sessions of a home delivered mindfulness intervention.

Participants receive weekly phone calls to assess symptoms.

Overall Number of Participants Analyzed 16 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Cancer-related worry - Time 2 8.26  (.58) 6.28  (.62)
Cancer-related worry - Time 3 7.88  (.58) 6.06  (.62)
Cancer-related worry - Summary 8.07  (.49) 6.17  (.53)
General worry - Time 2 5.89  (.52) 5.41  (.56)
General worry - Time 3 7.88  (.58) 6.06  (.62)
General worry - Summary 8.07  (.49) 6.17  (.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Attention Control Group, Mindfulness Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments P values below 0.05 are considered statistically significant in this study.
Method Mixed Models Analysis
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
Hide Description 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).
Time Frame Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptom Assessment Mindfulness Intervention
Hide Arm/Group Description:

6 weeks of symptom assessment phone calls.

symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks.

Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.

symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks.

Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.

Overall Number of Participants Analyzed 16 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
PSSQ_I Quality -Time 2 10.62  (1.95) 8.71  (2.14)
PSSQ_I Quality-Time 3 12.93  (1.99) 8.17  (2.08)
PSSQ_I Quality- Overall 11.76  (1.75) 8.38  (1.87)
PSSQ_I Interference- Time 2 6.45  (1.47) 5.99  (1.55)
PSSQ_I Interference- Time 3 9.26  (1.54) 6.28  (1.55)
PSSQ_I Interference- Overall 7.80  (1.25) 6.13  (1.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symptom Assessment, Mindfulness Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments P values below 0.05 are considered statistically significant in this study.
Method Mixed Models Analysis
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Baseline Values for All Measures.
Hide Description Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.
Time Frame Baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptom Assessment Mindfulness Intervention
Hide Arm/Group Description:

weekly phone calls.

symptom assessment: attention control group

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 Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
MDASI Symptom Severity (range 0-130) 29.25  (19.18) 35  (21.26)
MDASI Symptom Interference (range 0-50) 19.15  (16.41) 21.25  (16.2)
HRQOL -Physical Function (range 0-100) 35.25  (10.17) 37.73  (8.90)
HRQOL - Physical Role Function (range 0-100) 40.31  (10.47) 38.97  (9.64)
HRQOL - Bodily Pain (range 0-100) 47.36  (12.29) 41.96  (9.59)
HRQOL - General Health (range 0-100) 46.43  (11.66) 41.89  (11.60)
HRQOL - Vitality (range 0-100) 45.91  (11.96) 42.2  (7.5)
HRQOL - Social Function (range 0-100) 47.56  (10.72) 41.55  (11.42)
HRQOL - Emotional Function(range 0-100) 47.12  (12.75) 46.77  (11.25)
HRQOL - Mental Health (range 0-100) 49.56  (10.13) 45.37  (10.07)
HRQOL - Physical Summary (range 0-100) 39.17  (10.43) 37.83  (8.91)
HRQOL - Mental Summary (range 0-100) 51.82  (12.23) 47.33  (11.01)
CESD - Depression (range 0-60) 10.35  (8.27) 15.9  (10.51)
CDS - Overall Dyspnea (range 0-42) 8.85  (8.86) 7.05  (6.23)
CDS - Effort (range 0-20) 4.85  (4.98) 4.45  (4.47)
CDS - Anxiety (range 0-16) 1.55  (2.72) .85  (1.5)
CDS - Discomfort (range 0-12) 2.45  (2.63) 1.75  (1.97)
Worry - General (range 3-15) 5.55  (3.09) 7.35  (4.07)
Worry - Cancer-related (range 3-15) 7.45  (3.63) 9.70  (3.57)
PSSQ_I Sleep quality (range 0-25) 11.65  (7.53) 14.47  (6.84)
PSSQ_I Sleep interference (range 0-32) 6.37  (6.18) 10.63  (8.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symptom Assessment, Mindfulness Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments P values above 0.05 are considered statistically insignificant in this study.
Method Descriptive statistics for outcomes
Comments [Not Specified]
Time Frame 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symptom Assessment Mindfulness Intervention
Hide Arm/Group Description

weekly phone calls.

symptom assessment: attention control group

Participants will receive 6 weeks of home-based mindfulness intervention.

Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.

All-Cause Mortality
Symptom Assessment Mindfulness Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Symptom Assessment Mindfulness Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Symptom Assessment Mindfulness Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rebecca H. Lehto, PhD, Assistant Professor
Organization: Michigan State University College of Nursing
Phone: 517-353-4757
EMail: rebecca.lehto@hc.msu.edu
Layout table for additonal information
Responsible Party: Rebecca Lehto, Michigan State University
ClinicalTrials.gov Identifier: NCT01565980    
Other Study ID Numbers: CTSI grant
First Submitted: March 22, 2012
First Posted: March 29, 2012
Results First Submitted: July 13, 2014
Results First Posted: November 17, 2014
Last Update Posted: November 17, 2014