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NCT01565980 · ClinicalTrials.gov registry record · NA
Mindfulness Therapy for Individuals With Lung Cancer
A NA study of Lung Cancer, sponsored by Michigan State University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT01565980 is a NA study of Lung Cancer that has completed, run by Michigan State University. The registered enrollment target is 40 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01565980, a NA study of Lung Cancer, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness Intervention
- BEHAVIORAL symptom assessment
Study Locations (3)
Michigan
- Michigan State University - East Lansing
- Allegiance Health - Jackson
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01565980
The ClinicalTrials.gov registry entry for NCT01565980 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness Intervention is the first listed.
NCT01565980 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Illinois.
Frequently Asked Questions
What is clinical trial NCT01565980 about?
NCT01565980 is a clinical study titled "Mindfulness Therapy for Individuals With Lung Cancer". 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 incl...
What is the current status of trial NCT01565980?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2012-03. Estimated completion is 2013-06.
What conditions does trial NCT01565980 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT01565980?
The interventions under investigation include: Mindfulness Intervention (BEHAVIORAL), symptom assessment (BEHAVIORAL).
Who is sponsoring clinical trial NCT01565980?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01565980 being conducted?
This trial has 3 study locations across Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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