Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 29, 2012
Results First Submitted Date  ICMJE July 13, 2014
Results First Posted Date  ICMJE November 17, 2014
Last Update Posted Date November 17, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2014)
  • M.D. Anderson Symptom Inventory (MDASI) [ Time Frame: 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 Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Changes in health related quality of life (HRQOL) [ Time Frame: Baseline to 10 weeks ]
HRQOL. HRQOL includes symptom (worry, dyspnea, insomnia, depressive symptoms), physical and social functioning, and general health parameters.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 14, 2014)
  • Center for Epidemiologic Studies Depression (CES-D) [ Time Frame: 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 Frame: 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 Frame: 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 Frame: 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. [ Time Frame: Baseline. ]
    Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Therapy for Individuals With Lung Cancer
Official Title  ICMJE A Mindfulness Intervention for Symptom Management in Lung Cancer
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%).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Behavioral: symptom assessment
    attention control receives a weekly symptom assessment phone interview for 6 weeks.
  • Behavioral: Mindfulness Intervention
    Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.
Study Arms  ICMJE
  • Active Comparator: symptom assessment
    6 weeks of symptom assessment phone calls.
    Intervention: Behavioral: symptom assessment
  • Experimental: Mindfulness intervention
    Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
    Interventions:
    • Behavioral: symptom assessment
    • Behavioral: Mindfulness Intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2013)
40
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2012)
36
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565980
Other Study ID Numbers  ICMJE CTSI grant
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca Lehto, Michigan State University
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca Lehto, PhD Michigan State University
PRS Account Michigan State University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP