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N/A N=40 Randomized Single-blind Supportive Care

Mindfulness Therapy for Individuals With Lung Cancer

Lung Cancer

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: M.D. Anderson Symptom Inventory (MDASI) — 33.91; 20.91; 33.04; 22.86 units on a scale — p=<.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
symptom assessment (Behavioral); Mindfulness Intervention (Behavioral)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Michigan State University
Primary completion
Jun 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
M.D. Anderson Symptom Inventory (MDASI)
33.91; 20.91; 33.04; 22.86; 32.11; 26.79 <.05 sig
PRIMARY
SF-36
34.94; 42.49; 36.86; 43.31; 35.90; 42.90 <0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and speak English
  • at least 21 years old
  • active treatment for a diagnosis of non-small cell lung cancer
  • Karnofsky score > 80
  • have a telephone by which they can be reached

Exclusion Criteria

  • current substance abuse other than tobacco
  • active treatment for psychiatric disorders excluding depression, and/or use of antipsychotic medications that would impede study participation.
  • cognitive impairment
  • active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses
  • diagnosis of small cell lung cancer
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01565980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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