- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03948100
Dyadisk yogaintervensjon for å forbedre fysisk ytelse og livskvalitet hos pasienter med stadium I-IV ikke-småcellet lunge- eller spiserørskreft som gjennomgår strålebehandling og deres omsorgspersoner
Dyadiske atferdsintervensjoner for å håndtere fysisk ytelse, symptomer og livskvalitet for pasienter som gjennomgår strålebehandling og deres familieomsorgspersoner
This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell lung or esophageal cancer undergoing radiotherapy and their caregivers. Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with non-small cell lung cancer and/or their caregivers.
Studieoversikt
Status
Forhold
- Stage IVA lungekreft AJCC v8
- Stage IVB lungekreft AJCC v8
- Ikke-småcellet lungekarsinom
- Stadium III lungekreft AJCC v8
- Stadium IV lungekreft AJCC v8
- Trinn II lungekreft AJCC v8
- Stage IIA lungekreft AJCC v8
- Stadium IIB lungekreft AJCC v8
- Stadium IIIA lungekreft AJCC v8
- Stadium IIIB lungekreft AJCC v8
- Esophageal karsinom
- Stage I lungekreft AJCC v8
- Stadium IA1 lungekreft AJCC v8
- Trinn IA2 lungekreft AJCC v8
- Stadium IA3 lungekreft AJCC v8
- Stage IB lungekreft AJCC v8
- Stadium IIIC lungekreft AJCC v8
Detaljert beskrivelse
PRIMARY OBJECTIVE:
I. To examine the extent to which the yoga program improves patient physical performance (i.e., 6-minute walk test [6MWT]) as compared to the education group.
SECONDARY OBJECTIVE:
I. To examine the extent to which the yoga program improves patient and caregiver quality of life (QOL) (SF-36) compared to the education group.
TERTIARY OBJECTIVES:
I. To explore if, compared to the education group, the yoga program improves symptom burden, reduces inflammatory cytokine and cortisol rhythmicity dysregulation, and improves dyadic symptom management skills at the end of treatment, which will in turn mediate intervention outcomes at the subsequent follow-up assessments.
II. To explore if baseline factors such as depressive symptoms moderate the treatment response. We also seek to explore if baseline factors such as depressive symptoms moderate the treatment response.
QUALITATIVE OBJECTIVE:
I. To understand the patient and caregiver experience of cancer, cancer treatment, and experience in the behavioral interventions, and explore emerging themes as possible mediators. We would also like to understand participants feedback on participating in this intervention via mobile application (app) delivery.
OUTLINE: Patients and caregivers are assigned to 1 of 2 groups.
GROUP I: Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.
GROUP II: Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.
After completion of study, patients and caregivers are followed up every 2 weeks for 3 months and then every month for up to 6 months.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kathrin Milbury
- Telefonnummer: 713-745-2868
- E-post: kmilbury@mdanderson.org
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- M D Anderson Cancer Center
-
Ta kontakt med:
- Kathrin Milbury
- Telefonnummer: 713-745-2868
- E-post: kmilbury@mdanderson.org
-
Hovedetterforsker:
- Kathrin Milbury
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- PATIENT ONLY: Diagnosed with stage I-IV non-small cell lung cancer (NSCLC) or esophageal cancer and going to receive at least 3 weeks of thoracic radiotherapy (RT)
- PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- PATIENT ONLY: Able to read, write and speak English
- PATIENT ONLY: Able to provide informed consent
- PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) who assists the patient during the cancer treatment (e.g., emotional support, transportation, meal preparation, care coordination, etc) per patient self-report. Note, patients must identify a family caregiver; however, the participation of the family caregiver is optional. For caregivers to be eligible, they must be at least 18 years old; able to read, write and speak English; and able to provide informed consent. Family caregivers may consent to participate in the intervention and caregiver assessments or only the assessments based on their preference.
Exclusion Criteria:
- PATIENT ONLY: Who have regularly (self-defined) participated in a mind-body practice in the year prior to diagnosis
- PATIENT ONLY: Patients who metastatic disease involving the central nervous system
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group I (dyadic yoga)
Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions. |
Ancillary studies
Andre navn:
Ancillary studies Undergo dyadic yoga
Andre navn:
|
|
Aktiv komparator: Group II (dyadic education)
Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions. |
Ancillary studies
Andre navn:
Ancillary studies Undergo dyadic education program
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient 6-minute walk test (6MWT)
Tidsramme: At 3 months post study
|
Descriptive statistics for study variables and potential covariates will be computed and distribution characteristics of the variables will be examined. The difference between dyadic yoga (DY) and dyadic edication (DE) at 3 month follow-up (3MFU) will be tested at a two-sided .05 significance level. |
At 3 months post study
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient and caregiver quality of life (QOL)
Tidsramme: Up to 6 months post study
|
Analyses will be similar to those for the primary outcome, except that we will use a dyadic model assuming additional dependence in outcomes between patient and caregiver outcomes. |
Up to 6 months post study
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kathrin Milbury, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Lungesykdommer
- Neoplasmer i hode og nakke
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Esophageal sykdommer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Neoplasmer i spiserøret
- Karsinom, ikke-småcellet lunge
- Undersøkelsesteknikker
- Terapeutikk
- Mind-kroppsbehandlinger
- Komplementære terapier
- Åndelige terapier
- Treningsbevegelsesteknikker
- Fysioterapi -modaliteter
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Barnehelsetjenester
- Community Health Services
- Forebyggende helsetjenester
- Sosioøkonomiske faktorer
- Befolkningskarakteristikker
- Metoder
- Yoga
- Tidlig intervensjon, pedagogisk
- Utdanningsstatus
Andre studie-ID-numre
- 2018-0503
- 2018-0503 (Annen identifikator: M D Anderson Cancer Center)
- NCI-2018-03913 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- R37CA231522 (U.S. NIH-stipend/kontrakt)
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