Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older (S-PACT)

11. september 2017 opdateret af: UNC Lineberger Comprehensive Cancer Center

A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)

This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina

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

61 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Men and women age 65 years and older
  • Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD

  • Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)

    • Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
    • Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
  • Moderate to severe fatigue (>4 on BFI)
  • Less than 120 minutes/week of physical activity
  • English speaking
  • Signed IRB approved written informed consent
  • Approval from their treating physician to engage in moderate-intensity physical activity
  • Patient-assessed ability to walk and engage in moderate physical activity
  • Willing and able to meet all study requirements.

Exclusion Criteria:

  • Receiving hormonal therapy for prostate cancer
  • Unable to walk or engage in moderate-intensity physical activity
  • Have BFI≤3.
  • Report more than 120 minutes/week of physical activity

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
This arm will begin the Walk With Ease program after the completion of chemotherapy.
Adfærdsmæssigt: Gå med lethed
Walk With Ease er Arthritis Foundations evidensbaserede gangintervention for at hjælpe med træthed og smerte. Interventionen er et selvstyret program, der hjælper med at guide deltagerne i et sikkert og behageligt gåprogram med et ultimativt mål om at gå 30 minutter om dagen, fem dage om ugen.
Andre navne:
  • WWE
Aktiv komparator: Wait List Control
The arm will begin the Walk With Ease program three months after completion of chemotherapy.
Adfærdsmæssigt: Gå med lethed
Walk With Ease er Arthritis Foundations evidensbaserede gangintervention for at hjælpe med træthed og smerte. Interventionen er et selvstyret program, der hjælper med at guide deltagerne i et sikkert og behageligt gåprogram med et ultimativt mål om at gå 30 minutter om dagen, fem dage om ugen.
Andre navne:
  • WWE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
Tidsramme: Three months
Change in fatigue will be measured using the FACIT-F.
Three months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
Tidsramme: Three months
This outcome will be measured by the Brief Fatigue Inventory
Three months
To report recruitment and retention in the study at 3 months
Tidsramme: Three months
Three months
To report recruitment and retention in the study at 6 months
Tidsramme: Six months
Six months
To measure implementation of and adherence to WWE
Tidsramme: Six months
Six months
To count the number of adverse events
Tidsramme: Six months
To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.
Six months
To measure change in engagement of walking over time from baseline to three months.
Tidsramme: Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Three Months
To measure change in physical function over time from baseline to three months.
Tidsramme: Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Physical function as measured by SPPB
Three Months
To measure change in quality of life over time from baseline to three months.
Tidsramme: Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.
Three Months
To measure change in self-efficacy over time from baseline to three months.
Tidsramme: Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Three Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Samarbejdspartnere

Breast Cancer Research Foundation

Efterforskere

  • Ledende efterforsker: Hyman B Muss, MD, UNC Lineberger Comprehensive Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 2014

Primær færdiggørelse (Faktiske)

1. august 2017

Studieafslutning (Faktiske)

1. august 2017

Datoer for studieregistrering

Først indsendt

20. juni 2014

Først indsendt, der opfyldte QC-kriterier

14. juli 2014

Først opslået (Skøn)

16. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LCCC1402

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 .

Kliniske forsøg med Gå med lethed

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Israel

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner