Mindfulness Therapy for Individuals With Lung Cancer

Browse trials for

• Lung Neoplasms 7,243

Keywords

• Lung cancer
• mindfulness therapy
• active treatment (radiation and/or chemotherapy)

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Lead sponsor

Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.

Study arms

• Active comparator
  symptom assessment

  6 weeks of symptom assessment phone calls.

  Behavioral: symptom assessment

• Experimental
  Mindfulness intervention

  Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.

  Behavioral: symptom assessment · Behavioral: Mindfulness Intervention

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.

Primary outcomes

1. 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.

2. 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.

Other outcomes

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Baseline characteristics

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. No abstract available. PubMed 25631362 ↗