Lung Cancer
Conditions
Keywords
Lung cancer, mindfulness therapy, active treatment (radiation and/or chemotherapy)
Brief summary
Managing psychological and physical symptoms to improve quality of life in patients with lung cancer are a major public health concern. Mindfulness-based therapies are showing promise in modifying psychological distress and improving quality of life in some cancer groups, but little testing has included lung cancer samples. Mindfulness-based therapies integrate meditation, breathing, and gentle yoga practices to promote an attitude of nonjudgmental acceptance and awareness of bodily states. Such strategies may promote well being, self-regulation, and symptom management. The study purpose was to test the acceptability, feasibility, and symptom / health-related quality of life (HRQOL) outcomes of a home-based mindfulness intervention for individuals with advanced lung cancer during non-curative treatment (radiation and/or chemotherapy). Acceptability and feasibility were measured via patient consent and retention rates, therapy expectancy, study adherence, attrition reasons, and quality assurance indicators. Efficacy was determined via symptom and HRQOL (health perceptions, physical and emotional function) outcomes. 40 patients undergoing treatment of non-small cell lung cancer were randomized to receive either six weekly mindfulness sessions (N=20) or an attention control condition (N=20). Outcome data was obtained at baseline (Time 1), post-intervention (Time 2, week 8), and four weeks after completion (Time 3, week 11). In addition, both groups received weekly symptom assessment interviews. The hypothesis was that the mindfulness group would report better symptom management and HRQOL (lower worry, dyspnea, insomnia, depression; higher physical and social function; more positive health perceptions) than the attention control group at the protocol end and that these differences will be sustained at Time 3.
Detailed description
The final sample (n = 32) included 16 patients in the intervention and 16 in the attention control group (study attrition (n = 8, 20%).
Interventions
BEHAVIORALsymptom assessment
attention control receives a weekly symptom assessment phone interview for 6 weeks.
BEHAVIORALMindfulness Intervention
Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.
Sponsors
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand and speak English 2. at least 21 years old 3. active treatment for a diagnosis of non-small cell lung cancer 4. Karnofsky score \> 80 5. have a telephone by which they can be reached
Exclusion criteria
1. current substance abuse other than tobacco 2. active treatment for psychiatric disorders excluding depression, and/or use of antipsychotic medications that would impede study participation. 3. cognitive impairment 4. active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses 5. diagnosis of small cell lung cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| M.D. Anderson Symptom Inventory (MDASI) | Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. | 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. |
| SF-36 | Time 2 (week 8), Time 3 (week 11), and overall average 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies Depression (CES-D) | 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. |
| Cancer Dyspnea Scale | 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). |
| Worry (Cancer-related and General) | 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. |
| Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | 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). |
| Baseline Values for All Measures. | Baseline. | Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Attention Control weekly symptom assessment phone calls. | 20 |
| Mindfulness Intervention Participants receive weekly symptom assessment phone calls.
Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | health complications | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | stopped medical treatment | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Attention Control | Total | Mindfulness Intervention |
|---|---|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 9.5 | 66.2 years STANDARD_DEVIATION 9.4 | 64.5 years STANDARD_DEVIATION 9.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 36 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 34 Participants | 18 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
M.D. Anderson Symptom Inventory (MDASI)
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.
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Group | M.D. Anderson Symptom Inventory (MDASI) | Symptom Severity - Time 2 | 33.91 units on a scale | Standard Error 3.94 |
| Attention Control Group | M.D. Anderson Symptom Inventory (MDASI) | Symptom Severity - Time 3 | 33.04 units on a scale | Standard Error 3.98 |
| Attention Control Group | M.D. Anderson Symptom Inventory (MDASI) | Symptom Severity - Summary | 32.11 units on a scale | Standard Error 2.64 |
| Attention Control Group | M.D. Anderson Symptom Inventory (MDASI) | Symptom Interference - Time 2 | 22.38 units on a scale | Standard Error 2.63 |
| Attention Control Group | M.D. Anderson Symptom Inventory (MDASI) | Symptom Interference - Time 3 | 19.27 units on a scale | Standard Error 2.65 |
| Attention Control Group | M.D. Anderson Symptom Inventory (MDASI) | Symptom Interference - Summary | 18.95 units on a scale | Standard Error 1.74 |
| Mindfulness Intervention | M.D. Anderson Symptom Inventory (MDASI) | Symptom Interference - Time 3 | 11.06 units on a scale | Standard Error 2.9 |
| Mindfulness Intervention | M.D. Anderson Symptom Inventory (MDASI) | Symptom Severity - Time 2 | 20.91 units on a scale | Standard Error 4.3 |
| Mindfulness Intervention | M.D. Anderson Symptom Inventory (MDASI) | Symptom Interference - Time 2 | 10.45 units on a scale | Standard Error 2.88 |
| Mindfulness Intervention | M.D. Anderson Symptom Inventory (MDASI) | Symptom Severity - Time 3 | 22.86 units on a scale | Standard Error 4.33 |
| Mindfulness Intervention | M.D. Anderson Symptom Inventory (MDASI) | Symptom Interference - Summary | 4.33 units on a scale | Standard Error 1.87 |
| Mindfulness Intervention | M.D. Anderson Symptom Inventory (MDASI) | Symptom Severity - Summary | 26.79 units on a scale | Standard Error 2.84 |
Comparison: 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.p-value: <0.05Mixed Models Analysis
Primary
SF-36
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.
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Group | SF-36 | Social Function - Time 2 | 39.88 units on a scale | Standard Error 2.22 |
| Attention Control Group | SF-36 | Physical Role Function - Time 3 | 41.82 units on a scale | Standard Error 2.27 |
| Attention Control Group | SF-36 | Social Function - Time 3 | 42.53 units on a scale | Standard Error 2.28 |
| Attention Control Group | SF-36 | Bodily Pain Summary | 44.93 units on a scale | Standard Error 2.25 |
| Attention Control Group | SF-36 | Social Function - Summary | 41.20 units on a scale | Standard Error 1.75 |
| Attention Control Group | SF-36 | Physical Function - Time 3 | 36.86 units on a scale | Standard Error 1.94 |
| Attention Control Group | SF-36 | Emotional Role Function - Time 2 | 49.28 units on a scale | Standard Error 1.78 |
| Attention Control Group | SF-36 | General Health - Time 2 | 46.05 units on a scale | Standard Error 1.9 |
| Attention Control Group | SF-36 | Emotional Role Function - Time 3 | 49.49 units on a scale | Standard Error 1.82 |
| Attention Control Group | SF-36 | Physical Role Function - Summary | 40.69 units on a scale | Standard Error 1.8 |
| Attention Control Group | SF-36 | Emotional Role Function - Summary | 49.38 units on a scale | Standard Error 1.68 |
| Attention Control Group | SF-36 | General Health Summary | 44.59 units on a scale | Standard Error 1.7 |
| Attention Control Group | SF-36 | Mental Health - Time 2 | 49.61 units on a scale | Standard Error 2.2 |
| Attention Control Group | SF-36 | Physical Role Function - Time 2 | 39.56 units on a scale | Standard Error 2.22 |
| Attention Control Group | SF-36 | Mental Health - Time 3 | 48.30 units on a scale | Standard Error 2.22 |
| Attention Control Group | SF-36 | Vitality Time 2 | 44.88 units on a scale | Standard Error 2.19 |
| Attention Control Group | SF-36 | Mental Health - Summary | 48.97 units on a scale | Standard Error 2.09 |
| Attention Control Group | SF-36 | Bodily Pain Time 2 | 44.81 units on a scale | Standard Error 2.52 |
| Attention Control Group | SF-36 | Physical Overall - Time 2 | 37.14 units on a scale | Standard Error 2.05 |
| Attention Control Group | SF-36 | Vitality Time 3 | 43.37 units on a scale | Standard Error 2.21 |
| Attention Control Group | SF-36 | Physical Overall - Time 3 | 38.29 units on a scale | Standard Error 2.05 |
| Attention Control Group | SF-36 | Physical Function - Summary | 35.90 units on a scale | Standard Error 1.73 |
| Attention Control Group | SF-36 | Physical Overall - Summary | 37.72 units on a scale | Standard Error 1.84 |
| Attention Control Group | SF-36 | Vitality Summary | 44.15 units on a scale | Standard Error 2.06 |
| Attention Control Group | SF-36 | Mental Overall - Time 2 | 50.72 units on a scale | Standard Error 2.16 |
| Attention Control Group | SF-36 | Bodily Pain Time 3 | 45.15 units on a scale | Standard Error 2.56 |
| Attention Control Group | SF-36 | Mental Overall - Time 3 | 49.84 units on a scale | Standard Error 2.14 |
| Attention Control Group | SF-36 | Physical Function -Time 2 | 34.94 units on a scale | Standard Error 1.94 |
| Mindfulness Intervention | SF-36 | Mental Overall - Time 3 | 54.94 units on a scale | Standard Error 2.29 |
| Mindfulness Intervention | SF-36 | Physical Function -Time 2 | 42.49 units on a scale | Standard Error 2.02 |
| Mindfulness Intervention | SF-36 | Physical Function - Time 3 | 43.31 units on a scale | Standard Error 2.02 |
| Mindfulness Intervention | SF-36 | Physical Function - Summary | 42.90 units on a scale | Standard Error 1.82 |
| Mindfulness Intervention | SF-36 | Physical Role Function - Time 2 | 41.61 units on a scale | Standard Error 2.37 |
| Mindfulness Intervention | SF-36 | Physical Role Function - Time 3 | 44.34 units on a scale | Standard Error 2.37 |
| Mindfulness Intervention | SF-36 | Physical Role Function - Summary | 42.97 units on a scale | Standard Error 1.91 |
| Mindfulness Intervention | SF-36 | Bodily Pain Time 2 | 51.22 units on a scale | Standard Error 2.67 |
| Mindfulness Intervention | SF-36 | Bodily Pain Time 3 | 46.58 units on a scale | Standard Error 2.69 |
| Mindfulness Intervention | SF-36 | Bodily Pain Summary | 48.89 units on a scale | Standard Error 2.39 |
| Mindfulness Intervention | SF-36 | General Health - Time 2 | 48.20 units on a scale | Standard Error 2.04 |
| Mindfulness Intervention | SF-36 | General Health Summary | 46.35 units on a scale | Standard Error 1.82 |
| Mindfulness Intervention | SF-36 | Vitality Time 2 | 47.49 units on a scale | Standard Error 2.34 |
| Mindfulness Intervention | SF-36 | Vitality Time 3 | 48.34 units on a scale | Standard Error 2.34 |
| Mindfulness Intervention | SF-36 | Vitality Summary | 47.92 units on a scale | Standard Error 2.19 |
| Mindfulness Intervention | SF-36 | Social Function - Time 2 | 47.54 units on a scale | Standard Error 2.38 |
| Mindfulness Intervention | SF-36 | Social Function - Time 3 | 48.97 units on a scale | Standard Error 2.38 |
| Mindfulness Intervention | SF-36 | Social Function - Summary | 48.25 units on a scale | Standard Error 1.86 |
| Mindfulness Intervention | SF-36 | Emotional Role Function - Time 2 | 51.15 units on a scale | Standard Error 1.93 |
| Mindfulness Intervention | SF-36 | Emotional Role Function - Time 3 | 51.40 units on a scale | Standard Error 1.94 |
| Mindfulness Intervention | SF-36 | Emotional Role Function - Summary | 51.28 units on a scale | Standard Error 1.82 |
| Mindfulness Intervention | SF-36 | Mental Health - Time 2 | 54.51 units on a scale | Standard Error 2.35 |
| Mindfulness Intervention | SF-36 | Mental Health - Time 3 | 54.51 units on a scale | Standard Error 2.35 |
| Mindfulness Intervention | SF-36 | Mental Health - Summary | 54.52 units on a scale | Standard Error 2.23 |
| Mindfulness Intervention | SF-36 | Physical Overall - Time 2 | 42.79 units on a scale | Standard Error 2.16 |
| Mindfulness Intervention | SF-36 | Physical Overall - Time 3 | 41.66 units on a scale | Standard Error 2.16 |
| Mindfulness Intervention | SF-36 | Physical Overall - Summary | 42.22 units on a scale | Standard Error 1.96 |
| Mindfulness Intervention | SF-36 | Mental Overall - Time 2 | 54.27 units on a scale | Standard Error 2.29 |
p-value: <0.05Mixed Models Analysis
Other Pre-specified
Baseline Values for All Measures.
Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.
Time frame: Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Physical Summary (range 0-100) | 39.17 units on a scale | Standard Deviation 10.43 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - General Health (range 0-100) | 46.43 units on a scale | Standard Deviation 11.66 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Mental Summary (range 0-100) | 51.82 units on a scale | Standard Deviation 12.23 |
| Attention Control Group | Baseline Values for All Measures. | MDASI Symptom Interference (range 0-50) | 19.15 units on a scale | Standard Deviation 16.41 |
| Attention Control Group | Baseline Values for All Measures. | CESD - Depression (range 0-60) | 10.35 units on a scale | Standard Deviation 8.27 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Vitality (range 0-100) | 45.91 units on a scale | Standard Deviation 11.96 |
| Attention Control Group | Baseline Values for All Measures. | CDS - Overall Dyspnea (range 0-42) | 8.85 units on a scale | Standard Deviation 8.86 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Physical Role Function (range 0-100) | 40.31 units on a scale | Standard Deviation 10.47 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Social Function (range 0-100) | 47.56 units on a scale | Standard Deviation 10.72 |
| Attention Control Group | Baseline Values for All Measures. | CDS - Anxiety (range 0-16) | 1.55 units on a scale | Standard Deviation 2.72 |
| Attention Control Group | Baseline Values for All Measures. | MDASI Symptom Severity (range 0-130) | 29.25 units on a scale | Standard Deviation 19.18 |
| Attention Control Group | Baseline Values for All Measures. | CDS - Discomfort (range 0-12) | 2.45 units on a scale | Standard Deviation 2.63 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Emotional Function(range 0-100) | 47.12 units on a scale | Standard Deviation 12.75 |
| Attention Control Group | Baseline Values for All Measures. | Worry - General (range 3-15) | 5.55 units on a scale | Standard Deviation 3.09 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Bodily Pain (range 0-100) | 47.36 units on a scale | Standard Deviation 12.29 |
| Attention Control Group | Baseline Values for All Measures. | Worry - Cancer-related (range 3-15) | 7.45 units on a scale | Standard Deviation 3.63 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL - Mental Health (range 0-100) | 49.56 units on a scale | Standard Deviation 10.13 |
| Attention Control Group | Baseline Values for All Measures. | PSSQ_I Sleep quality (range 0-25) | 11.65 units on a scale | Standard Deviation 7.53 |
| Attention Control Group | Baseline Values for All Measures. | HRQOL -Physical Function (range 0-100) | 35.25 units on a scale | Standard Deviation 10.17 |
| Attention Control Group | Baseline Values for All Measures. | PSSQ_I Sleep interference (range 0-32) | 6.37 units on a scale | Standard Deviation 6.18 |
| Attention Control Group | Baseline Values for All Measures. | CDS - Effort (range 0-20) | 4.85 units on a scale | Standard Deviation 4.98 |
| Mindfulness Intervention | Baseline Values for All Measures. | PSSQ_I Sleep interference (range 0-32) | 10.63 units on a scale | Standard Deviation 8.05 |
| Mindfulness Intervention | Baseline Values for All Measures. | MDASI Symptom Severity (range 0-130) | 35 units on a scale | Standard Deviation 21.26 |
| Mindfulness Intervention | Baseline Values for All Measures. | MDASI Symptom Interference (range 0-50) | 21.25 units on a scale | Standard Deviation 16.2 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL -Physical Function (range 0-100) | 37.73 units on a scale | Standard Deviation 8.9 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Physical Role Function (range 0-100) | 38.97 units on a scale | Standard Deviation 9.64 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Bodily Pain (range 0-100) | 41.96 units on a scale | Standard Deviation 9.59 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - General Health (range 0-100) | 41.89 units on a scale | Standard Deviation 11.6 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Vitality (range 0-100) | 42.2 units on a scale | Standard Deviation 7.5 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Social Function (range 0-100) | 41.55 units on a scale | Standard Deviation 11.42 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Emotional Function(range 0-100) | 46.77 units on a scale | Standard Deviation 11.25 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Mental Health (range 0-100) | 45.37 units on a scale | Standard Deviation 10.07 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Physical Summary (range 0-100) | 37.83 units on a scale | Standard Deviation 8.91 |
| Mindfulness Intervention | Baseline Values for All Measures. | HRQOL - Mental Summary (range 0-100) | 47.33 units on a scale | Standard Deviation 11.01 |
| Mindfulness Intervention | Baseline Values for All Measures. | CESD - Depression (range 0-60) | 15.9 units on a scale | Standard Deviation 10.51 |
| Mindfulness Intervention | Baseline Values for All Measures. | CDS - Overall Dyspnea (range 0-42) | 7.05 units on a scale | Standard Deviation 6.23 |
| Mindfulness Intervention | Baseline Values for All Measures. | CDS - Effort (range 0-20) | 4.45 units on a scale | Standard Deviation 4.47 |
| Mindfulness Intervention | Baseline Values for All Measures. | CDS - Anxiety (range 0-16) | .85 units on a scale | Standard Deviation 1.5 |
| Mindfulness Intervention | Baseline Values for All Measures. | CDS - Discomfort (range 0-12) | 1.75 units on a scale | Standard Deviation 1.97 |
| Mindfulness Intervention | Baseline Values for All Measures. | Worry - General (range 3-15) | 7.35 units on a scale | Standard Deviation 4.07 |
| Mindfulness Intervention | Baseline Values for All Measures. | Worry - Cancer-related (range 3-15) | 9.70 units on a scale | Standard Deviation 3.57 |
| Mindfulness Intervention | Baseline Values for All Measures. | PSSQ_I Sleep quality (range 0-25) | 14.47 units on a scale | Standard Deviation 6.84 |
p-value: <0.05Descriptive statistics for outcomes
Other Pre-specified
Cancer Dyspnea Scale
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Group | Cancer Dyspnea Scale | CDS total score - Time 2 | 7.69 units on a scale | Standard Error 1.1 |
| Attention Control Group | Cancer Dyspnea Scale | CDS total score - Time 3 | 7.50 units on a scale | Standard Error 1.1 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - total score - Summary | 7.60 units on a scale | Standard Error 0.99 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - effort - Time 2 | 4.25 units on a scale | Standard Error 0.54 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - effort - Time 3 | 4.44 units on a scale | Standard Error 0.54 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - effort - summary | 4.34 units on a scale | Standard Error 0.5 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - anxiety - Time 2 | .93 units on a scale | Standard Error 0.4 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - anxiety - Time 3 | .80 units on a scale | Standard Error 0.4 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - anxiety - summary | .87 units on a scale | Standard Error 0.32 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - discomfort - Time 2 | 2.80 units on a scale | Standard Error 0.56 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - discomfort - Time 3 | 2.55 units on a scale | Standard Error 0.56 |
| Attention Control Group | Cancer Dyspnea Scale | CDS - discomfort - summary | 2.68 units on a scale | Standard Error 0.48 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - discomfort - Time 3 | .16 units on a scale | Standard Error 0.6 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS total score - Time 2 | 4.07 units on a scale | Standard Error 1.19 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - anxiety - Time 2 | .79 units on a scale | Standard Error 0.43 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS total score - Time 3 | 3.21 units on a scale | Standard Error 1.19 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - discomfort - Time 2 | .87 units on a scale | Standard Error 0.6 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - total score - Summary | 3.64 units on a scale | Standard Error 1.07 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - anxiety - Time 3 | .58 units on a scale | Standard Error 0.43 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - effort - Time 2 | 2.06 units on a scale | Standard Error 0.58 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - discomfort - summary | .51 units on a scale | Standard Error 0.52 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - effort - Time 3 | 2.14 units on a scale | Standard Error 0.59 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - anxiety - summary | .69 units on a scale | Standard Error 0.34 |
| Mindfulness Intervention | Cancer Dyspnea Scale | CDS - effort - summary | 2.10 units on a scale | Standard Error 0.54 |
p-value: <0.05Mixed Models Analysis
Other Pre-specified
Center for Epidemiologic Studies Depression (CES-D)
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Group | Center for Epidemiologic Studies Depression (CES-D) | CESD - Time 2 | 12.70 units on a scale | Standard Error 1.84 |
| Attention Control Group | Center for Epidemiologic Studies Depression (CES-D) | CESD - Time 3 | 12.83 units on a scale | Standard Error 1.84 |
| Attention Control Group | Center for Epidemiologic Studies Depression (CES-D) | CESD - Summary | 12.76 units on a scale | Standard Error 1.68 |
| Mindfulness Intervention | Center for Epidemiologic Studies Depression (CES-D) | CESD - Time 2 | 8.07 units on a scale | Standard Error 1.97 |
| Mindfulness Intervention | Center for Epidemiologic Studies Depression (CES-D) | CESD - Time 3 | 7.63 units on a scale | Standard Error 1.97 |
| Mindfulness Intervention | Center for Epidemiologic Studies Depression (CES-D) | CESD - Summary | 7.84 units on a scale | Standard Error 1.8 |
p-value: <0.05Mixed Models Analysis
Other Pre-specified
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Group | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Quality -Time 2 | 10.62 units on a scale | Standard Error 1.95 |
| Attention Control Group | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Quality-Time 3 | 12.93 units on a scale | Standard Error 1.99 |
| Attention Control Group | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Quality- Overall | 11.76 units on a scale | Standard Error 1.75 |
| Attention Control Group | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Interference- Time 2 | 6.45 units on a scale | Standard Error 1.47 |
| Attention Control Group | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Interference- Time 3 | 9.26 units on a scale | Standard Error 1.54 |
| Attention Control Group | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Interference- Overall | 7.80 units on a scale | Standard Error 1.25 |
| Mindfulness Intervention | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Interference- Time 3 | 6.28 units on a scale | Standard Error 1.55 |
| Mindfulness Intervention | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Quality -Time 2 | 8.71 units on a scale | Standard Error 2.14 |
| Mindfulness Intervention | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Interference- Time 2 | 5.99 units on a scale | Standard Error 1.55 |
| Mindfulness Intervention | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Quality-Time 3 | 8.17 units on a scale | Standard Error 2.08 |
| Mindfulness Intervention | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Interference- Overall | 6.13 units on a scale | Standard Error 1.29 |
| Mindfulness Intervention | Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I) | PSSQ_I Quality- Overall | 8.38 units on a scale | Standard Error 1.87 |
p-value: <0.05Mixed Models Analysis
Other Pre-specified
Worry (Cancer-related and General)
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control Group | Worry (Cancer-related and General) | Cancer-related worry - Time 2 | 8.26 units on a scale | Standard Error 0.58 |
| Attention Control Group | Worry (Cancer-related and General) | Cancer-related worry - Time 3 | 7.88 units on a scale | Standard Error 0.58 |
| Attention Control Group | Worry (Cancer-related and General) | Cancer-related worry - Summary | 8.07 units on a scale | Standard Error 0.49 |
| Attention Control Group | Worry (Cancer-related and General) | General worry - Time 2 | 5.89 units on a scale | Standard Error 0.52 |
| Attention Control Group | Worry (Cancer-related and General) | General worry - Time 3 | 7.88 units on a scale | Standard Error 0.58 |
| Attention Control Group | Worry (Cancer-related and General) | General worry - Summary | 8.07 units on a scale | Standard Error 0.49 |
| Mindfulness Intervention | Worry (Cancer-related and General) | General worry - Time 3 | 6.06 units on a scale | Standard Error 0.62 |
| Mindfulness Intervention | Worry (Cancer-related and General) | Cancer-related worry - Time 2 | 6.28 units on a scale | Standard Error 0.62 |
| Mindfulness Intervention | Worry (Cancer-related and General) | General worry - Time 2 | 5.41 units on a scale | Standard Error 0.56 |
| Mindfulness Intervention | Worry (Cancer-related and General) | Cancer-related worry - Time 3 | 6.06 units on a scale | Standard Error 0.62 |
| Mindfulness Intervention | Worry (Cancer-related and General) | General worry - Summary | 6.17 units on a scale | Standard Error 0.53 |
| Mindfulness Intervention | Worry (Cancer-related and General) | Cancer-related worry - Summary | 6.17 units on a scale | Standard Error 0.53 |
p-value: <0.05Mixed Models Analysis