Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
14. november 2019 oppdatert av: University of Wisconsin, Madison
Reducing Work Disability in Breast Cancer Survivors
This randomized clinical trial studies an educational intervention for reducing work disability in breast cancer survivors.
Web sites providing symptom management education may be an effective method to help breast cancer survivors reduce work disability after treatment
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. Determine the feasibility and usability of the Work Ability Improvement Through Symptom Management and Ergonomic Strategies (WISE) and empirically evaluate its effect on short-term work ability among breast cancer survivors (BCS).
SECONDARY OBJECTIVES:
I. Explore individual and workplace factors associated with work ability in BCS.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
ARM II: Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
After completion of study treatment, patients are followed up at 3 and 6 months.
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
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Hospital and Clinics
-
-
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
25 år til 64 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Diagnosed with breast cancer
- Employed at time of cancer diagnosis (defined as paid employment > 20 hours/week)
- Within six months of completion of active treatment
- Working during treatment or intending to return to work following active treatment
- Computer and internet access
Exclusion Criteria:
- Patients who do not intend to continue/resume working following treatment
- Develop distant metastases or progressive disease
- Prior diagnosis of malignancy at any other site except for in situ carcinomas of the cervix or non-melanomatous skin cancers
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm I (WISE)
Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications.
Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
|
Hjelpestudier
Hjelpestudier
Andre navn:
Receive access to the WISE web-based educational intervention
Receive standard of care
Andre navn:
Receive access to the WISE web-based educational intervention
Andre navn:
|
|
Aktiv komparator: Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
|
Hjelpestudier
Hjelpestudier
Andre navn:
Receive standard of care
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Tidsramme: 3 months
|
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
|
3 months
|
|
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Tidsramme: 6 months
|
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
|
6 months
|
|
Work ability, assessed by the Work Limitations Questionnaire (WLQ)
Tidsramme: Baseline
|
Baseline
|
|
|
Work ability, assessed by the WLQ
Tidsramme: 3 months
|
3 months
|
|
|
Work ability, assessed by the WLQ
Tidsramme: 6 months
|
6 months
|
|
|
Individual factors, including symptoms assessed using the Symptom Bother-Revised scale (SB-R) and MD Anderson Symptom Inventory (MDASI), socio-demographic factors, individual disease factors, and treatment factors
Tidsramme: Baseline
|
Baseline
|
|
|
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Tidsramme: 3 months
|
3 months
|
|
|
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Tidsramme: 6 months
|
6 months
|
|
|
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
Tidsramme: Baseline
|
Baseline
|
|
|
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Tidsramme: 3 months
|
3 months
|
|
|
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Feasibility measures, including participation/dropout rates, patient satisfaction, usability/satisfaction with WISE, knowledge/use of self-care symptom management/ergonomic strategies, and use of ergonomic/symptom management strategies, and barriers
Tidsramme: Up to 6 months
|
Up to 6 months
|
|
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
Tidsramme: Up to 6 months
|
Up to 6 months
|
|
Individuals self-reported work ability, using the Work Ability Index (WAI)
Tidsramme: Up to 6 months
|
Up to 6 months
|
|
Employment status
Tidsramme: Up to 6 months
|
Up to 6 months
|
|
Change in job performance or difficulty performing work tasks
Tidsramme: Baseline to 6 months
|
Baseline to 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mary Sesto, University of Wisconsin, Madison
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. juli 2015
Primær fullføring (Faktiske)
1. oktober 2015
Studiet fullført (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først innsendt
21. februar 2013
Først innsendt som oppfylte QC-kriteriene
21. februar 2013
Først lagt ut (Anslag)
26. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. november 2019
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OS12115
- A536130 (Annen identifikator: UW Madison)
- NCI-2012-03055 (Registeridentifikator: NCI Trial ID)
- 2012-0729 (Annen identifikator: Institutional Review Board)
- SMPH\ORTHOPEDIC&REHAB\PT (Annen identifikator: UW Madison)
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. .