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Mindfulness Therapy for Individuals With Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
symptom assessment
Mindfulness Intervention
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung cancer, mindfulness therapy, active treatment (radiation and/or chemotherapy)

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University
  • Michigan State University
  • Allegiance Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

symptom assessment

Mindfulness intervention

Arm Description

6 weeks of symptom assessment phone calls.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2012
Last Updated
November 14, 2014
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT01565980
Brief Title
Mindfulness Therapy for Individuals With Lung Cancer
Official Title
A Mindfulness Intervention for Symptom Management in Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, mindfulness therapy, active treatment (radiation and/or chemotherapy)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
symptom assessment
Arm Type
Active Comparator
Arm Description
6 weeks of symptom assessment phone calls.
Arm Title
Mindfulness intervention
Arm Type
Experimental
Arm Description
Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
Intervention Type
Behavioral
Intervention Name(s)
symptom assessment
Intervention Description
attention control receives a weekly symptom assessment phone interview for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Intervention
Intervention Description
Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.
Primary Outcome Measure Information:
Title
M.D. Anderson Symptom Inventory (MDASI)
Description
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 Frame
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Title
SF-36
Description
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 Frame
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Other Pre-specified Outcome Measures:
Title
Center for Epidemiologic Studies Depression (CES-D)
Description
The score is the sum of the 20 questions. Each item has a range of 1 - 4 for frequency of a behavior or mental state in the past week ; 1 - Rarely or none of the time (less than 1 day); 2 = Some or a little of the time (1-2 days); 3 = Occasionally or a moderate amount of time (3-4 days); 4 = Most or all of the time (5-7 days). Possible range is 0-60. There are 4 reverse-scored items (questions 4, 8, 12, and 16). A score of 16 points or more is considered depressed.
Time Frame
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Title
Cancer Dyspnea Scale
Description
The cancer dyspnea scale (CDS) has 12 Likert scale items ( 1 = Not at all, 5 = Very much) that ask questions about breathlessness or difficulty in breathing during the past few days. The CDS has an overall score (range 0-42) and 3 subscales that measure the amount of effort with breathing, anxiety associated with breathing, and discomfort associated with breathing. The 3 subscales are calculated by: 1) effort (items 4+6+8+10+12) - 5 [range 0 (no dyspnea effort)-20 (worst dyspnea effort)]; 2) anxiety (items 5+7+9+11) - 4 [range 0 (no dyspnea anxiety) - 16 (worst dyspnea anxiety)]; 3) discomfort [15 - (items 1+2+3) {range 0 (no dyspnea discomfort) - 12 (worst dyspnea discomfort)}]. The total dyspnea score is derived by adding the total subscale scores. The subscale score subtractions are to make adjustments for 0 as a state of absence of dyspnea (thus total dyspnea summary scores range from 0 to 42).
Time Frame
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Title
Worry (Cancer-related and General)
Description
Both cancer-related and general worry were measured with 3 item scales. Cancer-related worry had three statements asking about level of worry related to diagnosis, treatment, and worry interference using a 1 = "not at all" to 5 = "most or all the time" scale, range 3-15. Items are summed. General worry used an abbreviated brief Penn State Worry questionnaire with 3 statements that measure how typical that statements are in describing the person. Uses a 3 item scale with 1 = "not at all typical" to 5 = "very typical". the range is 3-15. Items are summed.
Time Frame
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Title
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
Description
The PSSQ_I has 13 self rated questions. The first 5 items, used to determine sleep quality (presence; frequency of insomnia problems) are rated [0 = never to 5 = always, 5-7 days per week; (range 0-25)] and items 6 to 13 are aimed at identifying the degree of interference experienced from sleep impairment (rated 0=not at all to 4=extremely on Likert scale; range 0 - 32).
Time Frame
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Title
Baseline Values for All Measures.
Description
Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Lehto, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25631362
Citation
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.
Results Reference
derived

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Mindfulness Therapy for Individuals With Lung Cancer

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