Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Reducing Work Disability in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799031
• Other study ID #: OS12115
• Secondary ID: NCI-2012-0305520
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor

Intervention

Other:
• internet-based intervention
Receive access to the WISE web-based educational intervention

Procedure:
• management of therapy complications
Receive standard of care

Other:
• educational intervention
Receive access to the WISE web-based educational intervention
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Work ability, assessed by the Work Limitations Questionnaire (WLQ)		Baseline
Primary	Work ability, assessed by the WLQ		3 months
Primary	Work ability, assessed by the WLQ		6 months
Primary	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
Primary	Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors		3 months
Primary	Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors		6 months
Primary	Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)		Baseline
Primary	Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ		3 months
Primary	Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ		6 months
Secondary	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
Secondary	Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation		Up to 6 months
Secondary	Individuals self-reported work ability, using the Work Ability Index (WAI)		Up to 6 months
Secondary	Employment status		Up to 6 months
Secondary	Change in job performance or difficulty performing work tasks		Baseline to 6 months

External Links

•   University of Wisconsin Carbone Cancer Center