Educational Intervention for Reducing Work Disability in Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Cancer Survivor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

internet-based intervention

Intervention Type OTHER

Receive access to the WISE web-based educational intervention

management of therapy complications

Intervention Type PROCEDURE

Receive standard of care

educational intervention

Intervention Type OTHER

Receive access to the WISE web-based educational intervention

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Arm II (control)

Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights.

Group Type ACTIVE_COMPARATOR

management of therapy complications

Intervention Type PROCEDURE

Receive standard of care

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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internet-based intervention

Receive access to the WISE web-based educational intervention

Intervention Type OTHER

management of therapy complications

Receive standard of care

Intervention Type PROCEDURE

educational intervention

Receive access to the WISE web-based educational intervention

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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complications of therapy, management of intervention, educational quality of life assessment

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No