Mindfulness Therapy for Individuals With Lung Cancer

Michigan State University

Status: Completed

Conditions: Lung Cancer

Treatments: Behavioral: Mindfulness Intervention; Behavioral: symptom assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01565980

CTSI grant

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

symptom assessment

Active Comparator group

Description:

6 weeks of symptom assessment phone calls.

Treatment:

Behavioral: symptom assessment

Mindfulness intervention

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Intervention

Behavioral: symptom assessment