- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01565980
Mindfulness Therapy for Individuals With Lung Cancer
A Mindfulness Intervention for Symptom Management in Lung Cancer
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60208
- Northwestern University
-
-
Michigan
-
East Lansing, Michigan, Forente stater, 48824
- Michigan State University
-
Jackson, Michigan, Forente stater, 49201
- Allegiance Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: symptom assessment
6 weeks of symptom assessment phone calls.
|
attention control receives a weekly symptom assessment phone interview for 6 weeks.
|
Eksperimentell: Mindfulness intervention
Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
M.D. Anderson Symptom Inventory (MDASI)
Tidsramme: 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
Tidsramme: 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.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Center for Epidemiologic Studies Depression (CES-D)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: Baseline.
|
Description of all measures are described elsewhere.
Provided are the means and standard deviations for baseline comparisons.
|
Baseline.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rebecca Lehto, PhD, Michigan State University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CTSI grant
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Lungekreft
-
Yonsei UniversityFullført
-
Novartis PharmaceuticalsFullførtNevroendokrine svulster | Avansert NET av GI Origin | Advanced NET of Lung OriginForente stater, Colombia, Italia, Taiwan, Storbritannia, Belgia, Tsjekkia, Tyskland, Japan, Saudi-Arabia, Canada, Nederland, Spania, Korea, Republikken, Libanon, Østerrike, Kina, Hellas, Sør-Afrika, Thailand, Ungarn, Tyrkia, Polen, Slov... og mer
-
The Cleveland ClinicTilbaketrukketOne Lung Ventillation (OLV) | To lungeventilasjon (TLV) | Positivt End Expiratory Pressure (PEEP) | Null sluttekspirasjonstrykk (ZEEP)
-
Assiut UniversityHar ikke rekruttert ennåLungekreft | Lungeskade | Bleb Lung
-
RenJi HospitalRekrutteringMultiple Synchronous Lung Cancers (MSLC)Kina
-
Poitiers University HospitalFullførtEndobronchial Transbronchial Needle Aspiration Lung Cancer Procore
-
University of LorraineFullførtBare barn | Spontan pneumothorax | Idiopatisk pneumotoraks | Bleb LungFrankrike
-
AHS Cancer Control AlbertaCross Cancer InstituteFullførtOmfattende Stage Small Cel Lung CancerCanada
-
Damascus UniversityUniversity Children's HospitalFullførtEsophageal atresi | One Lung Ventilation OLV | Hydrocystoma | Pneumonektomi | Pleura; AbscessDen syriske arabiske republikk
-
Ministry of Health, Saudi ArabiaHar ikke rekruttert ennåLuftveissykdom | Prematuritet | Ventilator Lung; Nyfødt
Kliniske studier på symptom assessment
-
M.D. Anderson Cancer CenterFullførtAvansert kreftForente stater
-
University of South FloridaUkjentGastroøsofageal reflukslidelseForente stater
-
National Institute of Allergy and Infectious Diseases...Rho Federal Systems Division, Inc.FullførtSARS-CoV-2 | Coronavirus Disease 2019 (COVID-19)Forente stater
-
Memorial Sloan Kettering Cancer CenterFullførtKreft i spiserøretForente stater
-
University of WinchesterUniversity College DublinFullførtSlag | Fysisk aktivitet | Gangart, hemiplegiskStorbritannia
-
Rigshospitalet, DenmarkNovo Nordisk A/SFullførtHematologisk malignitet | GVHD, kroniskDanmark
-
Mutah UniversityIstishari Urology CenterFullført
-
Swing Therapeutics, Inc.FullførtFibromyalgiForente stater
-
Thomas Jefferson UniversityFullførtHematopoetisk og lymfoid celle-neoplasma | Ondartet fast neoplasmaForente stater