Mindfulness Therapy for Individuals With Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebecca Lehto, Michigan State University
ClinicalTrials.gov Identifier:
NCT01565980
First received: March 22, 2012
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

Managing psychological and physical symptoms to improve quality of life in patients with lung cancer are a major public health concern. Mindfulness-based therapies, a form of supportive complementary and alternative medicine (CAM), 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 interventions are grounded in evidence that meditation including breathing exercises, and gentle yoga enhance patients' ability to adapt to serious medical concerns. The study purpose is to test the acceptability, feasibility, and health-related quality of life (HRQOL) outcomes of a home-based mindfulness intervention for individuals with lung cancer who are undergoing non-curative treatment. Acceptability and feasibility will be measured via patient consent and retention rates, therapy expectancy, study adherence, attrition reasons, and quality assurance indicators. Efficacy will be determined by HRQOL outcomes: symptoms; function; and health perceptions. Thirty-six individuals undergoing treatment of non-small cell lung cancer will be randomly assigned to receive either six weekly mindfulness sessions (N=18) or an attention control condition (N=18). Symptom data will be collected weekly to document the process of change in symptoms in both groups. HRQOL data will be obtained at baseline (Time 1), following the intervention (Time 2), and four weeks after completion (Time 3). The hypothesis is that the mindfulness group will have better HRQOL (less 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.


Condition Intervention
Lung Cancer
Behavioral: symptom assessment
Behavioral: Mindfulness Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Changes in health related quality of life (HRQOL) [ Time Frame: Baseline to 10 weeks ] [ Designated as safety issue: No ]
    HRQOL. HRQOL includes symptom (worry, dyspnea, insomnia, depressive symptoms), physical and social functioning, and general health parameters.


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: symptom assessment
weekly phone calls.
Behavioral: symptom assessment
attention control group
Experimental: Mindfulness intervention
Participants will receive 6 weeks of home-based mindfulness intervention.
Behavioral: Mindfulness Intervention
Participants will receive a weekly home-based mindfulness intervention.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;47 and 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;
  3. cognitive impairment;
  4. current active anti-cancer treatment;
  5. participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses; and
  6. diagnosis of small cell lung cancer. We excluded small cell lung cancer because of its very different disease presentation and its associated very rapid disease progression.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565980

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Allegiance Health
Jackson, Michigan, United States, 49201
Sponsors and Collaborators
Michigan State University
  More Information

No publications provided

Responsible Party: Rebecca Lehto, PhD, RN, Assistant Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01565980     History of Changes
Other Study ID Numbers: CTSI grant
Study First Received: March 22, 2012
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
Lung cancer
mindfulness therapy
active treatment (radiation and/or chemotherapy)

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014