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Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01799031
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer Survivor Other: internet-based intervention Procedure: management of therapy complications Other: educational intervention Other: questionnaire administration Procedure: quality-of-life assessment Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Reducing Work Disability in Breast Cancer Survivors
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: internet-based intervention
Receive access to the WISE web-based educational intervention

Procedure: management of therapy complications
Receive standard of care
Other Name: complications of therapy, management of

Other: educational intervention
Receive access to the WISE web-based educational intervention
Other Name: intervention, educational

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Active Comparator: Arm II (control)
Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Procedure: management of therapy complications
Receive standard of care
Other Name: complications of therapy, management of

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment




Primary Outcome Measures :
  1. Usability of the WISE website as assessed by responses to a 5-point Likert scale [ Time Frame: 3 months ]
    The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.

  2. Usability of the WISE website as assessed by responses to a 5-point Likert scale [ Time Frame: 6 months ]
    The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.

  3. Work ability, assessed by the Work Limitations Questionnaire (WLQ) [ Time Frame: Baseline ]
  4. Work ability, assessed by the WLQ [ Time Frame: 3 months ]
  5. Work ability, assessed by the WLQ [ Time Frame: 6 months ]
  6. 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 [ Time Frame: Baseline ]
  7. Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors [ Time Frame: 3 months ]
  8. Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors [ Time Frame: 6 months ]
  9. Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ) [ Time Frame: Baseline ]
  10. Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ [ Time Frame: 3 months ]
  11. Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Up to 6 months ]
  2. Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation [ Time Frame: Up to 6 months ]
  3. Individuals self-reported work ability, using the Work Ability Index (WAI) [ Time Frame: Up to 6 months ]
  4. Employment status [ Time Frame: Up to 6 months ]
  5. Change in job performance or difficulty performing work tasks [ Time Frame: Baseline to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799031


Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mary Sesto University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01799031    
Other Study ID Numbers: OS12115
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 )
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: July 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases