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Reducing Work Disability in Breast Cancer Survivors


N/A
25 Years
64 Years
Open (Enrolling)
Female
Breast Cancer, Cancer Survivor

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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 ClinicsMadison, Wisconsin  53792-0001