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Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy (PEDWAY)

1. mai 2017 oppdatert av: Margie McNeely, University of Alberta

Feasibility of a Supported Walking Program for Breast and Head-and-Neck Cancer Survivors Receiving Adjuvant Radiation Therapy

This pilot study will assess whether a supported pedometer-based walking program is helpful in maintaining physical activity for breast and head-and-neck cancer patients who are undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide support for physical activity during radiation therapy. We will also examine the relationship of physical activity and quality of life outcomes to help inform future research.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Will the integration of a patient-centered exercise prescription and supportive counseling attenuate declines in physical activity during radiation therapy? To address this question, this study will assess the feasibility of a patient-centered walking program for breast and head-and-neck cancer patients undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide support and ongoing counseling to facilitate increased activity (through walking) during radiation therapy. We will also examine the effect of the walking program on other outcomes such as happiness, depression and sleep to determine point estimates and measures of variability to inform future research.

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6J4P9
        • Cross Cancer Institute

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

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Survivors with a diagnosis of breast cancer or head and neck cancer
  • Adults aged 18 years or older
  • Commencing adjuvant radiation therapy treatments
  • Karnofsky Performance Status greater than or equal to 60%

Exclusion Criteria:

  • Clinical or radiological evidence of active disease, either local or metastatic
  • Serious non-malignant disease, such as cardiac failure or advanced arthritis of weight bearing joints, which would preclude daily treatment and follow-up
  • Patients for whom physical activity or exercise is contraindicated
  • Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol
  • Unable to comply with the protocol, measurement and follow-up schedule (e.g., scheduling conflicts, time commitment)

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
Eksperimentell: Walking Intervention
Pedometer Walking Program
Atferdsmessig: Pedometer Walking Program
All subjects will be prescribed a low-intensity walking program based on their current activity level and an daily assigned step count goal (with the current physical activity recommendations of 30 minutes of moderate-to-vigorous activity per day or 150 minutes per week as the ideal goal). Participants will be provided with face-to-face counseling and written material describing their specific individualized walking program. Participants will also be instructed to maintain their normal activities as much as possible during the intervention period. Participants will be given a pedometer and instructed to wear it at least 5 days per week for the duration of the study.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accrual Rate and Completion Rate
Tidsramme: Anticipated duration of radiation therapy of 6 weeks
Accrual: Number of participants agreeing to participate divided by the number of eligible participants Completion rate: number of participants completing the trial
Anticipated duration of radiation therapy of 6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence
Tidsramme: Anticipated duration of radiation therapy of 6 weeks
Adherence to the intervention protocol: number of days meeting target step count
Anticipated duration of radiation therapy of 6 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6-Minute Walk Test
Tidsramme: Change from baseline to anticipated end of radiation therapy of 6 weeks
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a six minutes time period on a hard, flat surface (e.g., 100 foot hallway).
Change from baseline to anticipated end of radiation therapy of 6 weeks
Physical Activity
Tidsramme: Change from baseline to anticipated duration of radiation therapy of 6 weeks
An accelerometer armband will be used to provide a breakdown of an individual's daily activity.
Change from baseline to anticipated duration of radiation therapy of 6 weeks
Self-esteem
Tidsramme: Change from baseline to anticipated duration of radiation therapy of 6 weeks
Rosenberg Self-Esteem Scale (10 item)
Change from baseline to anticipated duration of radiation therapy of 6 weeks
Depression
Tidsramme: Change from baseline to anticipated duration of radiation therapy of 6 weeks
Beck Depression Inventory II (21 item)
Change from baseline to anticipated duration of radiation therapy of 6 weeks
Happiness
Tidsramme: Change from baseline to anticipated duration of radiation therapy of 6 weeks
Oxford Happiness Questionnaire (29 items)
Change from baseline to anticipated duration of radiation therapy of 6 weeks
Sleep
Tidsramme: Change from baseline to anticipated duration of radiation therapy of 6 weeks
Pittsburgh Sleep Quality Index (9 item)
Change from baseline to anticipated duration of radiation therapy of 6 weeks
Fatigue
Tidsramme: Recorded daily during study period of 6 weeks
Visual analogue scale, recorded as part of daily diary
Recorded daily during study period of 6 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

University of Alberta

Etterforskere

  • Hovedetterforsker: Margaret McNeely, PhD, University of Alberta and Cross Cancer Institute

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. juni 2013

Primær fullføring (Faktiske)

1. oktober 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

16. juni 2013

Først innsendt som oppfylte QC-kriteriene

25. juni 2013

Først lagt ut (Anslag)

26. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2017

Sist bekreftet

1. mai 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • ACREC 26059

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

No plan in place

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. .

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