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Completed

NCT Number: NCT01565980

Mindfulness Therapy for Individuals With Lung Cancer

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

The final sample (n = 32) included 16 patients in the intervention and 16 in the attention control group (study attrition (n = 8, 20%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and speak English
  • at least 21 years old
  • active treatment for a diagnosis of non-small cell lung cancer
  • Karnofsky score > 80
  • have a telephone by which they can be reached

Exclusion criteria

  • current substance abuse other than tobacco
  • active treatment for psychiatric disorders excluding depression, and/or use of antipsychotic medications that would impede study participation.
  • cognitive impairment
  • active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses
  • diagnosis of small cell lung cancer

Treatment and study plan

Symptom Assessment

Behavioral

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

Mindfulness Intervention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Official study title

A Mindfulness Intervention for Symptom Management in Lung Cancer

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2012
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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