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Hula, a Physical Activity Intervention for Female-Cancer Survivors

16. april 2019 oppdatert av: University of Hawaii
A six-month interventional program to determine the biological and psychosocial effects of hula as a form of physical activity for female breast, cervical, endometrial or ovarian cancer survivors living on Oahu.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

73

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
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • University of Hawaii 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

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Lives on Oahu
  • Diagnosed with primary breast,cervical, endometrial or ovarian cancer (stage I-III)
  • Completed initial regional and systemic treatment for breast cancer 2 months ago
  • Physically capable of doing the hula-based physical activity
  • Receives approval by attending physician to participate in trial

Exclusion Criteria:

  • Currently undergoing chemotherapy or radiation therapy

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Hula
Hula is an ancient, Native Hawaiian dance form of cultural expression and physical activity. Participants will attend one-hour hula classes twice a week for six months.
Atferdsmessig: Hula

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hula Program Feasibility (Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention)
Tidsramme: 6 months after the start of the intervention program
Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention
6 months after the start of the intervention program

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
Circulating levels of sex hormones measured in serum samples.
Baseline, 6 months and 12 months after the start of the intervention program
Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
Circulating levels of cytokines measured in serum samples.
Baseline, 6 months and 12 months after the start of the intervention program
Biomarkers - Inflammatory Markers (Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.
Baseline, 6 months and 12 months after the start of the intervention program
DNA Methylation Patterns (DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Demographics (Collectively looking at demographic items as measured on the baseline questionnaire, including ethnicity, education, family, history of cancer, stage of cancer, treatment type, and comorbidities.)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
Collectively looking at demographic items as measured on the baseline questionnaire, including ethnicity, education, family, history of cancer, stage of cancer, treatment type, and comorbidities.
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Physical Activity (Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Health-Related Quality of Life (Quality of life of participants assessed using The European Organization for Research and Treatment of Cancer QLQ-C30.)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
The severity and impact of fatigue on daily functioning assessed using The Brief Fatigue Inventory (BFI).
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Depression (indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
The presence of depression as indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED).
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Affective States (assessed using The Profile of Mood States short form (POMS-SF) questionnaire.)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
Affect of participants assessed using The Profile of Mood States short form (POMS-SF) questionnaire.
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.)
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
How people adjust and cope with a cancer diagnosis assessed using The 10-item Social Constraints Scale.
Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog
Tidsramme: Baseline, 6 months and 12 months after the start of the intervention program
2 subscales assess cognitive deficiency and cognitive capability
Baseline, 6 months and 12 months after the start of the intervention program

Samarbeidspartnere og etterforskere

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

Sponsor

University of Hawaii

Etterforskere

  • Hovedetterforsker: Erin Bantum, MA, PhD, University of Hawaii Cancer Research Center

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

1. september 2013

Primær fullføring (Faktiske)

1. desember 2017

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

20. januar 2015

Først innsendt som oppfylte QC-kriteriene

29. januar 2015

Først lagt ut (Anslag)

30. januar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Bantum-2013-2

Plan for individuelle deltakerdata (IPD)

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produkt produsert i og eksportert fra USA

Nei

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