Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

NCT01799031 — Not applicable, Completed, 44 participants, University of Wisconsin, Madison

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Reducing Work Disability in Breast Cancer Survivors

RegistryNCT01799031
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment44 (Actual)
SponsorUniversity of Wisconsin, Madison (Other); collaborators: National Cancer Institute (NCI)
ConditionsBreast Cancer, Cancer Survivor
Interventionsinternet-based intervention, management of therapy complications, educational intervention, questionnaire administration, quality-of-life assessment (Other, procedure)
Datesstart 2015-07-01, primary completion 2015-10-01, completion 2017-06-01, first posted 2013-02-26, last updated 2019-11-18
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer All trials for Cancer Survivor All trials of internet-based intervention All trials of management of therapy complications

-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Arm I (WISE)ExperimentalOther: internet-based intervention; Procedure: management of therapy complications; Other: educational intervention; Other: questionnaire administration; Procedure: quality-of-life assessmentPatients 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)Active comparatorProcedure: management of therapy complications; Other: questionnaire administration; Procedure: quality-of-life assessmentPatients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.
  • internet-based intervention (Other): Receive access to the WISE web-based educational intervention
  • management of therapy complications (Procedure), also known as complications of therapy, management of: Receive standard of care
  • educational intervention (Other), also known as intervention, educational: Receive access to the WISE web-based educational intervention
  • questionnaire administration (Other): Ancillary studies
  • quality-of-life assessment (Procedure), also known as quality of life assessment: Ancillary studies

+Outcome measures

Primary outcomes

  • Usability of the WISE website as assessed by responses to a 5-point Likert scale [3 months]: The primary analysis of the effect of the WISE intervention on work ability will be performed using a Wilcoxon rank sum test.
  • 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 [3 months]
  • Work ability, assessed by the WLQ [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]
  • Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors [3 months]
  • Individual factors, including symptoms assessed using the SB-R and MDASI, socio-demographic factors, individual disease factors, and treatment factors [6 months]
  • 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 [3 months]
  • Workplace factors, including work history, job characteristics, job control, job support, and level of job stress using the JCQ [6 months]

Secondary outcomes

  • 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]
  • Individuals self-reported work ability, using the Work Ability Index (WAI) [Up to 6 months]
  • Employment status [Up to 6 months]
  • Change in job performance or difficulty performing work tasks [Baseline to 6 months]

+Eligibility

Sex: Female, ages: 25 Years to 64 Years

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

+Locations (1)

FacilityCityCountryStatus
University of Wisconsin Hospital and ClinicsMadison, WisconsinUnited States

+Investigators

  • Mary Sesto, Principal investigator, University of Wisconsin, Madison