Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Mary Sesto; University of Wisconsin, Madison

More Information

Additional Information:

University of Wisconsin Carbone Cancer Center 

• 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
• Last Update Posted: November 18, 2019
• Last Verified: July 2017

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases