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Mindfulness Therapy for Individuals With Lung Cancer

14 novembre 2014 aggiornato da: Rebecca Lehto, Michigan State University

A Mindfulness Intervention for Symptom Management in Lung Cancer

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60208
        • Northwestern University
    • Michigan
      • East Lansing, Michigan, Stati Uniti, 48824
        • Michigan State University
      • Jackson, Michigan, Stati Uniti, 49201
        • Allegiance Health

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: symptom assessment
6 weeks of symptom assessment phone calls.
Comportamentale: symptom assessment
attention control receives a weekly symptom assessment phone interview for 6 weeks.
Sperimentale: Mindfulness intervention
Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
Comportamentale: symptom assessment
attention control receives a weekly symptom assessment phone interview for 6 weeks.
Comportamentale: Mindfulness Intervention
Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
M.D. Anderson Symptom Inventory (MDASI)
Lasso di tempo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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
Lasso di tempo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Center for Epidemiologic Studies Depression (CES-D)
Lasso di tempo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Cancer Dyspnea Scale
Lasso di tempo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

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.
Worry (Cancer-related and General)
Lasso di tempo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
Lasso di tempo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
Baseline Values for All Measures.
Lasso di tempo: Baseline.
Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.
Baseline.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Michigan State University

Investigatori

  • Investigatore principale: Rebecca Lehto, PhD, Michigan State University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2012

Completamento primario (Effettivo)

1 giugno 2013

Completamento dello studio (Effettivo)

1 giugno 2013

Date di iscrizione allo studio

Primo inviato

22 marzo 2012

Primo inviato che soddisfa i criteri di controllo qualità

27 marzo 2012

Primo Inserito (Stima)

29 marzo 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 novembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 novembre 2014

Ultimo verificato

1 novembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CTSI grant

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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