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Dyadisk yogaintervensjon for forbedring av helsetjenester og livskvalitet hos pasienter med hode- og nakkekreft som gjennomgår kjemoradiasjon og deres omsorgspersoner

25. september 2026 oppdatert av: M.D. Anderson Cancer Center

Forbedring av helsetjenester og livskvalitet hos hode- og nakkekreftpasienter som gjennomgår kjemoradiasjon og deres familieomsorgspersoner

This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. Examine the efficacy of the dyadic yoga (DY) intervention regarding reduced patient emergency department (ED) visits and feeding tube (FT) insertions and improved patient and caregiver quality of life (QOL) as compared to the usual care (UC) group.

II. Estimate intervention costs, direct medical costs, indirect costs (i.e., productivity loss), and evaluate the overall cost-effectiveness of the DY intervention for patients and caregivers.

III. Demonstrate that, compared to the UC group, the DY program improves patient and caregiver symptoms burden, objective physical function, and illness communication and reduces patient use of opioids during chemoradiotherapy (CRT), which will in turn mediate intervention outcomes at the follow-up assessments.

IV. Understand the patient and caregiver experience of head and neck cancer (HNC), healthcare utilization and symptom management and emerging themes as possible mediators as they relate to or suggest modifications of our proposed model using qualitative methods.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.

ARM II: Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.

After completion of study, participants are followed up every 2 weeks for 3 months and then monthly for up to 6 months.

Studietype

Intervensjonell

Registrering (Faktiske)

415

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Houston, Texas, Forente stater, 77030
        • M D Anderson Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • PATIENTS: Diagnosed with a primary HNC and going to receive at least 5 weeks (25 fractions) of CRT
  • PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • PATIENTS: Having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate
  • PATIENTS AND CAREGIVERS: Must be at least 18 years old
  • PATIENTS AND CAREGIVERS: Able to read and speak English
  • PATIENTS AND CAREGIVERS: Able to provide informed consent

Exclusion Criteria:

  • PATIENTS AND CAREGIVERS: Who have regularly (self-defined) participated in a yoga program in the year prior to diagnosis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm I (Standard of care)

Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.
Annen: Questionnaire Administration

Ancillary studies

Annen: Best Practice

Receive standard care

Andre navn:
  • velferdstandard
  • standard terapi
Annen: Arm II (exercise, yoga sessions)

Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.
Annen: Questionnaire Administration

Ancillary studies

Annen: Best Practice

Receive standard care

Andre navn:
  • velferdstandard
  • standard terapi
Annen: Exercise Intervention

Participate in yoga sessions

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient healthcare utilization (Standard of care)
Tidsramme: Up to 6 months with 3 months follow-up

Will examine group differences in patient emergency department visit (yes/no) during the observation period of during and up to 3 months post chemoradiotherapy (CRT) as the primary outcome. Will use logistic regression with the randomization factors as covariates, as these factors may be associated with the study outcomes, and controlling for them is likely to increase the power to detect the between-group differences.
Up to 6 months with 3 months follow-up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Caregiver quality of life questionnaire (RAND 36-Item Health Survey)
Tidsramme: Up to 6 months with 3 months follow-up

Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate.

Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue)
Up to 6 months with 3 months follow-up
Patient quality of life questionnaire
Tidsramme: Up to 6 months with 3 months follow-up

Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate.

Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue)
Up to 6 months with 3 months follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

M.D. Anderson Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Kathrin Milbury, M.D. Anderson Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. januar 2021

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

27. januar 2021

Først innsendt som oppfylte QC-kriteriene

12. mai 2021

Først lagt ut (Faktiske)

18. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2020-0311
  • 2020-0311 (Annen identifikator: M D Anderson Cancer Center)
  • NCI-2020-13884 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • R01CA247307 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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