Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy (PEDWAY)
1. maj 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T6J4P9
- Cross Cancer Institute
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Walking Intervention
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Margaret McNeely, PhD, University of Alberta and Cross Cancer Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2013
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
16. juni 2013
Først indsendt, der opfyldte QC-kriterier
25. juni 2013
Først opslået (Skøn)
26. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ACREC 26059
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
No plan in place
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .