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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.
The final sample (n = 32) included 16 patients in the intervention and 16 in the attention control group (study attrition (n = 8, 20%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symptom assessment | Active Comparator | 6 weeks of symptom assessment phone calls. |
|
| Mindfulness intervention | Experimental | Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| symptom assessment | Behavioral | attention control receives a weekly symptom assessment phone interview for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
| 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 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Lehto, PhD | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60208 | United States | ||
| Michigan State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25631362 | Derived | Lehto RH, Wyatt G, Sikorskii A, Tesnjak I, Kaufman VH. Home-based mindfulness therapy for lung cancer symptom management: a randomized feasibility trial. Psychooncology. 2015 Sep;24(9):1208-12. doi: 10.1002/pon.3755. Epub 2015 Jan 28. No abstract available. |
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There were no participants excluded from the trial before group assignment. However, there were patients who dropped from the study before starting the intervention.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Symptom Assessment | weekly phone calls. symptom assessment: attention control group |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | weekly symptom assessment phone calls. |
| BG001 | Mindfulness Intervention | Participants receive weekly symptom assessment phone calls. Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symptom Assessment | weekly phone calls. symptom assessment: attention control group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca H. Lehto, PhD, Assistant Professor | Michigan State University College of Nursing | 517-353-4757 | rebecca.lehto@hc.msu.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Mindfulness Intervention | Behavioral | Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks. |
|
| Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
| 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 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
| 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 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
| 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 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
| Baseline Values for All Measures. | Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons. | Baseline. |
| East Lansing |
| Michigan |
| 48824 |
| United States |
| Allegiance Health | Jackson | Michigan | 49201 | United States |
| health complications |
|
| stopped medical treatment |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Attention Control Group | weekly phone calls. symptom assessment interview. |
| OG001 | Mindfulness Intervention | Participants receive 6 weekly sessions of a home delivered mindfulness intervention. Participants receive weekly phone calls to assess symptoms. |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
|
|
|
|
| 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). | Posted | Least Squares Mean | Standard Error | units on a scale | Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
|
|
|
|
| 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). | Posted | Least Squares Mean | Standard Error | units on a scale | Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline. |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Mindfulness Intervention | Participants will receive 6 weeks of home-based mindfulness intervention. Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention. | 0 | 20 | 0 | 20 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Physical Function - Summary |
|
| Physical Role Function - Time 2 |
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| Physical Role Function - Time 3 |
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| Physical Role Function - Summary |
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| Bodily Pain Time 2 |
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| Bodily Pain Time 3 |
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| Bodily Pain Summary |
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| General Health - Time 2 |
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| General Health Summary |
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| Vitality Time 2 |
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| Vitality Time 3 |
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| Vitality Summary |
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| Social Function - Time 2 |
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| Social Function - Time 3 |
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| Social Function - Summary |
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| Emotional Role Function - Time 2 |
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| Emotional Role Function - Time 3 |
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| Emotional Role Function - Summary |
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| Mental Health - Time 2 |
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| Mental Health - Time 3 |
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| Mental Health - Summary |
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| Physical Overall - Time 2 |
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| Physical Overall - Time 3 |
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| Physical Overall - Summary |
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| Mental Overall - Time 2 |
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| Mental Overall - Time 3 |
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| CESD - Summary |
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| CDS - total score - Summary |
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| CDS - effort - Time 2 |
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| CDS - effort - Time 3 |
|
| CDS - effort - summary |
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| CDS - anxiety - Time 2 |
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| CDS - anxiety - Time 3 |
|
| CDS - anxiety - summary |
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| CDS - discomfort - Time 2 |
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| CDS - discomfort - Time 3 |
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| CDS - discomfort - summary |
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| Cancer-related worry - Summary |
|
| General worry - Time 2 |
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| General worry - Time 3 |
|
| General worry - Summary |
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| PSSQ_I Quality- Overall |
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| PSSQ_I Interference- Time 2 |
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| PSSQ_I Interference- Time 3 |
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| PSSQ_I Interference- Overall |
|
| HRQOL -Physical Function (range 0-100) |
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| HRQOL - Physical Role Function (range 0-100) |
|
| HRQOL - Bodily Pain (range 0-100) |
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| HRQOL - General Health (range 0-100) |
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| HRQOL - Vitality (range 0-100) |
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| HRQOL - Social Function (range 0-100) |
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| HRQOL - Emotional Function(range 0-100) |
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| HRQOL - Mental Health (range 0-100) |
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| HRQOL - Physical Summary (range 0-100) |
|
| HRQOL - Mental Summary (range 0-100) |
|
| CESD - Depression (range 0-60) |
|
| CDS - Overall Dyspnea (range 0-42) |
|
| CDS - Effort (range 0-20) |
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| CDS - Anxiety (range 0-16) |
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| CDS - Discomfort (range 0-12) |
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| Worry - General (range 3-15) |
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| Worry - Cancer-related (range 3-15) |
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| PSSQ_I Sleep quality (range 0-25) |
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| PSSQ_I Sleep interference (range 0-32) |
|