Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
Reducing Work Disability in Breast Cancer Survivors
5 other identifiers
interventional
44
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedNovember 18, 2019
July 1, 2017
3 months
February 21, 2013
November 14, 2019
Conditions
Outcome Measures
Primary Outcomes (11)
Usability of the WISE website as assessed by responses to a 5-point Likert scale
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
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)
Baseline
Work ability, assessed by the WLQ
3 months
Work ability, assessed by the WLQ
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
Baseline
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
3 months
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
6 months
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
Baseline
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
3 months
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
6 months
Secondary Outcomes (5)
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
Up to 6 months
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
Up to 6 months
Individuals self-reported work ability, using the Work Ability Index (WAI)
Up to 6 months
Employment status
Up to 6 months
Change in job performance or difficulty performing work tasks
Baseline to 6 months
Study Arms (2)
Arm I (WISE)
EXPERIMENTALPatients 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 (control)
ACTIVE COMPARATORPatients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Interventions
Receive access to the WISE web-based educational intervention
Receive standard of care
Receive access to the WISE web-based educational intervention
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Sesto
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2013
First Posted
February 26, 2013
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
June 1, 2017
Last Updated
November 18, 2019
Record last verified: 2017-07