Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
14 november 2019 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
44
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Hospital and Clinics
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år till 64 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Sidostudier
Sidostudier
Andra namn:
Receive access to the WISE web-based educational intervention
Receive standard of care
Andra namn:
Receive access to the WISE web-based educational intervention
Andra namn:
|
|
Aktiv komparator: Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
|
Sidostudier
Sidostudier
Andra namn:
Receive standard of care
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline
|
Baseline
|
|
|
Work ability, assessed by the WLQ
Tidsram: 3 months
|
3 months
|
|
|
Work ability, assessed by the WLQ
Tidsram: 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
Tidsram: Baseline
|
Baseline
|
|
|
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Tidsram: 3 months
|
3 months
|
|
|
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
Tidsram: 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)
Tidsram: Baseline
|
Baseline
|
|
|
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Tidsram: 3 months
|
3 months
|
|
|
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
Tidsram: 6 months
|
6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: Up to 6 months
|
Up to 6 months
|
|
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
Tidsram: Up to 6 months
|
Up to 6 months
|
|
Individuals self-reported work ability, using the Work Ability Index (WAI)
Tidsram: Up to 6 months
|
Up to 6 months
|
|
Employment status
Tidsram: Up to 6 months
|
Up to 6 months
|
|
Change in job performance or difficulty performing work tasks
Tidsram: Baseline to 6 months
|
Baseline to 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Mary Sesto, University of Wisconsin, Madison
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2015
Primärt slutförande (Faktisk)
1 oktober 2015
Avslutad studie (Faktisk)
1 juni 2017
Studieregistreringsdatum
Först inskickad
21 februari 2013
Först inskickad som uppfyllde QC-kriterierna
21 februari 2013
Första postat (Uppskatta)
26 februari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 november 2019
Senast verifierad
1 juli 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OS12115
- A536130 (Annan identifierare: UW Madison)
- NCI-2012-03055 (Registeridentifierare: NCI Trial ID)
- 2012-0729 (Annan identifierare: Institutional Review Board)
- SMPH\ORTHOPEDIC&REHAB\PT (Annan identifierare: UW Madison)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .