Reducing Work Disability in Breast Cancer Survivors
25 Years
64 Years
Female
Breast Cancer, Cancer Survivor
Trial Information
Reducing Work Disability in Breast Cancer Survivors
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Usability of the WISE website as assessed by responses to a 5-point Likert scale
Outcome Description:
The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Mary Sesto
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Institutional Review Board
Study ID:
OS12115
NCT ID:
NCT01799031
Start Date:
April 2013
Completion Date:
Related Keywords:
- Breast Cancer
- Cancer Survivor
- Breast Neoplasms
Name | Location |
|---|---|
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
