Clinical trial NCT01799031: Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
Official title: Reducing Work Disability in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer Survivor
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-02-26
Enrollment: 44
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Usability of the WISE website as assessed by responses to a 5-point Likert scale
timeFrame: 3 months
measure: Usability of the WISE website as assessed by responses to a 5-point Likert scale
timeFrame: 6 months
measure: Work ability, assessed by the Work Limitations Questionnaire (WLQ)
timeFrame: Baseline
measure: Work ability, assessed by the WLQ
timeFrame: 3 months
measure: Work ability, assessed by the WLQ
timeFrame: 6 months
measure: 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
timeFrame: Baseline
measure: Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
timeFrame: 3 months
measure: Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors
timeFrame: 6 months
measure: Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the Job Content Questionnaire (JCQ)
timeFrame: Baseline
measure: Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
timeFrame: 3 months
measure: Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: Up to 6 months
measure: Self-car symptom management strategies used (if any), workplace strategies implemented, and barriers to implementation
timeFrame: Up to 6 months
measure: Individuals self-reported work ability, using the Work Ability Index (WAI)
timeFrame: Up to 6 months
measure: Employment status
timeFrame: Up to 6 months
measure: Change in job performance or difficulty performing work tasks
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mary Sesto
role: PRINCIPAL_INVESTIGATOR
References: