- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01565980
Mindfulness Therapy for Individuals With Lung Cancer
A Mindfulness Intervention for Symptom Management in Lung Cancer
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60208
- Northwestern University
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Michigan
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East Lansing, Michigan, Vereinigte Staaten, 48824
- Michigan State University
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Jackson, Michigan, Vereinigte Staaten, 49201
- Allegiance Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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M.D. Anderson Symptom Inventory (MDASI)
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Center for Epidemiologic Studies Depression (CES-D)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Rebecca Lehto, PhD, Michigan State University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CTSI grant
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