Clinical trial NCT01565980: Mindfulness Therapy for Individuals With Lung Cancer
Official title: A Mindfulness Intervention for Symptom Management in Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
mindfulness therapy
active treatment (radiation and/or chemotherapy)
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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%).

Eligibility 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

Primary outcomes:
measure: M.D. Anderson Symptom Inventory (MDASI)
timeFrame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
measure: SF-36
timeFrame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Secondary outcomes:
Other outcomes:
measure: Center for Epidemiologic Studies Depression (CES-D)
timeFrame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
measure: Cancer Dyspnea Scale
timeFrame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
measure: Worry (Cancer-related and General)
timeFrame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
measure: Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
timeFrame: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
measure: Baseline Values for All Measures.
timeFrame: Baseline.
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
Study officials:
affiliation: Michigan State University
name: Rebecca Lehto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.