Mindfulness Therapy for Individuals With Lung Cancer
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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 |
- 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.
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | November 2012 (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 |
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;47 and 5) 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;
- cognitive impairment;
- current active anti-cancer treatment;
- participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses; and
- 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| Contact: Rebecca Lehto, PhD | 517-353-4757 |
| United States, Michigan | |
| Michigan State University | Not yet recruiting |
| East Lansing, Michigan, United States, 48824 | |
| Principal Investigator: Rebecca H Lehto, PhD, RN | |
| Sub-Investigator: Alla Sikorskii, PhD | |
| Sub-Investigator: Gwen Wyatt, PhD | |
| Allegiance Health | Not yet recruiting |
| Jackson, Michigan, United States, 49201 | |
| Contact: John Sturtevant, M.S. 517-788-4800 john.sturtevant@allegiancehealth.org | |
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: | March 27, 2012 |
| 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 June 13, 2013