Mindfulness Therapy for Individuals With Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: symptom assessment; Behavioral: Mindfulness Intervention

• Registration Number: NCT01565980
• Lead Sponsor: Michigan State University

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-07-13
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-14
• Last Update Submitted: 2014-11-14
• Results First Posted: 2014-11-17
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
M.D. Anderson Symptom Inventory (MDASI)	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 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.

Trial Locations

Locations (3)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

Allegiance Health; 🇺🇸 Jackson, Michigan, United States