Clinical Trials Directory

Trials / Completed

CompletedNCT01565980

Mindfulness Therapy for Individuals With Lung Cancer

A Mindfulness Intervention for Symptom Management in Lung Cancer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Michigan State University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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%).

Conditions

Interventions

TypeNameDescription
BEHAVIORALsymptom assessmentattention control receives a weekly symptom assessment phone interview for 6 weeks.
BEHAVIORALMindfulness InterventionParticipants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.

Timeline

Start date
2012-03-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2012-03-29
Last updated
2014-11-17
Results posted
2014-11-17

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01565980. Inclusion in this directory is not an endorsement.