Mindfulness Therapy for Individuals With Lung Cancer

NCT01565980 | Completed Results DMC

• 1 other identifier: CTSI grant
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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

Lung Cancer

Keywords

Lung cancer; mindfulness therapy; active treatment (radiation and/or chemotherapy)

Outcome Measures

Primary Outcomes (2)

• M.D. Anderson Symptom Inventory (MDASI)

  Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine." The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely"). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed.

  Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

• SF-36

  Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range). With normed scoring, general population has mean=50, SD=10. For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.

  Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

Other Outcomes (5)

• Center for Epidemiologic Studies Depression (CES-D)

  Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

• Cancer Dyspnea Scale

  Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

• Worry (Cancer-related and General)

  Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

Study Arms (2)

symptom assessment

ACTIVE COMPARATOR

6 weeks of symptom assessment phone calls.

Behavioral: symptom assessment

Mindfulness intervention

EXPERIMENTAL

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

Behavioral: symptom assessment; Behavioral: Mindfulness Intervention

Interventions

symptom assessment BEHAVIORAL

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

Mindfulness intervention; symptom assessment

Mindfulness Intervention BEHAVIORAL

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

Mindfulness intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (3)

Northwestern University

Chicago, Illinois, 60208, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Related Publications (1)

• 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.

  PMID: 25631362 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Rebecca H. Lehto, PhD, Assistant Professor
• Organization: Michigan State University College of Nursing

rebecca.lehto@hc.msu.edu

517-353-4757

Study Officials

• Rebecca Lehto, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Assistant Professor

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 17, 2014
• Results First Posted: November 17, 2014

Record last verified: 2014-11

Locations

US (3)