The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older (S-PACT)
11. september 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
44
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina
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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
61 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention
This arm will begin the Walk With Ease program after the completion of chemotherapy.
|
Walk With Ease er Arthritis Foundations evidensbaserte gangintervensjon for å hjelpe mot tretthet og smerte.
Intervensjonen er et selvstyrt program som hjelper deltakerne i et trygt og komfortabelt turprogram med et endelig mål om å gå i 30 minutter om dagen, fem dager i uken.
Andre navn:
|
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Aktiv komparator: Wait List Control
The arm will begin the Walk With Ease program three months after completion of chemotherapy.
|
Walk With Ease er Arthritis Foundations evidensbaserte gangintervensjon for å hjelpe mot tretthet og smerte.
Intervensjonen er et selvstyrt program som hjelper deltakerne i et trygt og komfortabelt turprogram med et endelig mål om å gå i 30 minutter om dagen, fem dager i uken.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
Tidsramme: Three months
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Change in fatigue will be measured using the FACIT-F.
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Three months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Three months
|
|
To report recruitment and retention in the study at 3 months
Tidsramme: Three months
|
Three months
|
|
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To report recruitment and retention in the study at 6 months
Tidsramme: Six months
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Six months
|
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To measure implementation of and adherence to WWE
Tidsramme: Six months
|
Six months
|
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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
|
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To measure change in engagement of walking over time from baseline to three months.
Tidsramme: Three Months
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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
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To measure change in physical function over time from baseline to three months.
Tidsramme: Three Months
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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
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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
|
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hyman B Muss, MD, UNC Lineberger Comprehensive Cancer Center
Publikasjoner og nyttige lenker
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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
1. juni 2014
Primær fullføring (Faktiske)
1. august 2017
Studiet fullført (Faktiske)
1. august 2017
Datoer for studieregistrering
Først innsendt
20. juni 2014
Først innsendt som oppfylte QC-kriteriene
14. juli 2014
Først lagt ut (Anslag)
16. juli 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. september 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2017
Sist bekreftet
1. september 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LCCC1402
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