Mindfulness Therapy for Individuals With Lung Cancer

• 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: Michigan State University
• Information provided by (Responsible Party): Rebecca Lehto, Michigan State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Behavioral: symptom assessment; Behavioral: Mindfulness Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Mindfulness Intervention for Symptom Management in Lung Cancer
• Study Start Date: March 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rebecca Lehto, PhD, RN, Assistant Professor, Michigan State University
• ClinicalTrials.gov Identifier: NCT01565980
• Other Study ID Numbers: CTSI grant
• First Posted: March 29, 2012
• Results First Posted: November 17, 2014
• Last Update Posted: November 17, 2014
• Last Verified: November 2014

Keywords provided by Rebecca Lehto, Michigan State University:

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

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases