Occupational Therapist-Led Work Intervention in Facilitating Work Maintenance or Re-entry to the Workforce in Patients With Stage I to III Breast Cancer Undergoing Chemotherapy

June 30, 2021 updated by: University of Washington

The Evaluation of a Work Intervention to Facilitate Work Maintenance or Re-Entry to the Workforce for Breast Cancer Patients

This trial studies how well occupational therapy (occupational therapist-led work intervention) works in facilitating work maintenance or re-entry to the workforce for stages I to III breast cancer patients who will be undergoing curative intent chemotherapy. Occupational therapy may help cancer patients maintain employment or successfully return to work soon after treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients receive in-person occupational therapist-led work consultation.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage I-III breast cancer patients who will be undergoing curative intent chemotherapy
  • Working in a paid capacity (part or full-time) at time of diagnosis with the intent to maintain or return to work following treatment

Exclusion Criteria:

  • Non-English speaking patients. This study requires completing online questionnaires that are written in English and will not be translated
  • Patients with a psychiatric or neurological condition that impairs capacity to make decisions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (Occupational therapy)
Patients receive in-person occupational therapist-led work consultation
Behavioral: Occupational Therapy
Receive in-person occupational therapist-led work consultation
Other Names:
  • Occupational Therapy, OT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perceived work ability
Time Frame: Baseline up to 3 years
Will be measured by the Work Abilities Index (WAI).
Baseline up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in health related quality of life
Time Frame: Baseline up to 3 years
Will be measured by the Functional Assessment of Cancer Therapy General (FACT-G), a validated measure for quality of life in patients with cancer.
Baseline up to 3 years
Change in financial toxicity
Time Frame: Baseline up to 3 years
Will be measured by the Comprehensive Score for Financial Toxicity (COST-FACIT), a validated measure for financial toxicity for clinically relevant patient-centered outcomes.
Baseline up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Rachel Yung, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2018

Primary Completion (Actual)

September 22, 2020

Study Completion (Actual)

September 22, 2020

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1718049
  • NCI-2018-02059 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 9993 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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