Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Cancer Survivor; Breast Cancer
• Interventions: Other: internet-based intervention; Procedure: management of therapy complications; Other: educational intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

• Registration Number: NCT01799031
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-26
• Study Start: 2015-07
• Primary Completion: 2015-10
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (WISE)	management of therapy complications	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 I (WISE)	educational intervention	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 I (WISE)	questionnaire administration	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 (control)	quality-of-life assessment	Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Arm I (WISE)	internet-based intervention	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 (control)	management of therapy complications	Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
Arm I (WISE)	quality-of-life assessment	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 (control)	questionnaire administration	Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.

Primary Outcome Measures

Name	Time	Method
Usability of the WISE website as assessed by responses to a 5-point Likert scale	6 months	The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
Work ability, assessed by the Work Limitations Questionnaire (WLQ)	Baseline
Work ability, assessed by the WLQ	6 months
Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors	6 months
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
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)	Baseline
Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ	6 months

Secondary Outcome Measures

Name	Time	Method
Employment status	Up to 6 months
Individuals self-reported work ability, using the Work Ability Index (WAI)	Up to 6 months
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
Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation	Up to 6 months
Change in job performance or difficulty performing work tasks	Baseline to 6 months

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States