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Mindfulness Therapy for Individuals With Lung Cancer

NCT ID: NCT01565980

Last Updated: 2014-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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The final sample (n = 32) included 16 patients in the intervention and 16 in the attention control group (study attrition (n = 8, 20%).

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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symptom assessment

6 weeks of symptom assessment phone calls.

Group Type ACTIVE_COMPARATOR

symptom assessment

Intervention Type BEHAVIORAL

attention control receives a weekly symptom assessment phone interview for 6 weeks.

Mindfulness intervention

Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.

Group Type EXPERIMENTAL

symptom assessment

Intervention Type BEHAVIORAL

attention control receives a weekly symptom assessment phone interview for 6 weeks.

Mindfulness Intervention

Intervention Type BEHAVIORAL

Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.

Interventions

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symptom assessment

attention control receives a weekly symptom assessment phone interview for 6 weeks.

Intervention Type BEHAVIORAL

Mindfulness Intervention

Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
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 that would impede study participation.
3. cognitive impairment
4. active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses
5. diagnosis of small cell lung cancer
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Lehto

PhD, RN, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Lehto, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Michigan State University

East Lansing, Michigan, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Countries

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United States

References

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Lehto RH, Wyatt G, Sikorskii A, Tesnjak I, Kaufman VH. Home-based mindfulness therapy for lung cancer symptom management: a randomized feasibility trial. Psychooncology. 2015 Sep;24(9):1208-12. doi: 10.1002/pon.3755. Epub 2015 Jan 28. No abstract available.

Reference Type DERIVED
PMID: 25631362 (View on PubMed)

Other Identifiers

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CTSI grant

Identifier Type: -

Identifier Source: org_study_id