- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01565980
Mindfulness Therapy for Individuals With Lung Cancer
A Mindfulness Intervention for Symptom Management in Lung Cancer
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60208
- Northwestern University
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Michigan
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East Lansing, Michigan, 미국, 48824
- Michigan State University
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Jackson, Michigan, 미국, 49201
- Allegiance Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: symptom assessment
6 weeks of symptom assessment phone calls.
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attention control receives a weekly symptom assessment phone interview for 6 weeks.
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실험적: Mindfulness intervention
Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
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attention control receives a weekly symptom assessment phone interview for 6 weeks.
Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
M.D. Anderson Symptom Inventory (MDASI)
기간: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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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.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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SF-36
기간: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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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.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Center for Epidemiologic Studies Depression (CES-D)
기간: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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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.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Cancer Dyspnea Scale
기간: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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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 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Worry (Cancer-related and General)
기간: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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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.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
기간: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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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).
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Baseline Values for All Measures.
기간: Baseline.
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Description of all measures are described elsewhere.
Provided are the means and standard deviations for baseline comparisons.
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Baseline.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rebecca Lehto, PhD, Michigan State University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CTSI grant
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