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Mindfulness Therapy for Individuals With Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebecca Lehto, Michigan State University
ClinicalTrials.gov Identifier:
NCT01565980
First received: March 22, 2012
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Behavioral: symptom assessment
Behavioral: Mindfulness Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Mindfulness Intervention for Symptom Management in Lung Cancer

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • M.D. Anderson Symptom Inventory (MDASI) [ Time Frame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Center for Epidemiologic Studies Depression (CES-D) [ Time Frame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: symptom assessment
6 weeks of symptom assessment phone calls.
Behavioral: symptom assessment
attention control receives a weekly symptom assessment phone interview for 6 weeks.
Experimental: Mindfulness intervention
Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
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.

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%).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565980

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Allegiance Health
Jackson, Michigan, United States, 49201
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Rebecca Lehto, PhD Michigan State University
  More Information

No publications provided

Responsible Party: Rebecca Lehto, PhD, RN, Assistant Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01565980     History of Changes
Other Study ID Numbers: CTSI grant
Study First Received: March 22, 2012
Results First Received: July 13, 2014
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
Lung cancer
mindfulness therapy
active treatment (radiation and/or chemotherapy)

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014