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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-03055 | Registry Identifier | NCI Trial ID | |
| 2012-0729 | Other Identifier | Institutional Review Board | |
| A536130 | Other Identifier | UW Madison | |
| SMPH\ORTHOPEDIC&REHAB\PT | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (WISE) | Experimental | 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. |
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| Arm II (control) | Active Comparator | Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| internet-based intervention | Other | Receive access to the WISE web-based educational intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Sesto | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| management of therapy complications | Procedure | Receive standard of care |
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| educational intervention | Other | Receive access to the WISE web-based educational intervention |
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| questionnaire administration | Other | Ancillary studies |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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