NCT03723863

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

October 23, 2018

Last Update Submit

June 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in perceived work ability

    Will be measured by the Work Abilities Index (WAI).

    Baseline up to 3 years

Secondary Outcomes (2)

  • Change in health related quality of life

    Baseline up to 3 years

  • Change in financial toxicity

    Baseline up to 3 years

Study Arms (1)

Supportive care (Occupational therapy)

EXPERIMENTAL

Patients receive in-person occupational therapist-led work consultation

Behavioral: Occupational Therapy

Interventions

Receive in-person occupational therapist-led work consultation

Also known as: Occupational Therapy, OT
Supportive care (Occupational therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Rachel Yung

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 30, 2018

Study Start

October 25, 2018

Primary Completion

September 22, 2020

Study Completion

September 22, 2020

Last Updated

July 6, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations