Employment Support After Hematopoietic Stem Cell Transplantation

NCT ID: NCT06494423

Last Updated: 2025-12-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2027-12-31

Brief Summary

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This is a feasibility study of a Work Support (WorkS) intervention designed to ameliorate employment challenges for people preparing to return to work after allogeneic stem cell transplantation. The aim of this study is to evaluate "proof of concept" by:

1. examining the feasibility and acceptability of the WorkS intervention and the study procedures, and
2. exploring the preliminary effects of WorkS for improving patient-reported return-to-work self-efficacy, work status, quality of life, and financial toxicity.

Detailed Description

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Participants will be recruited from MGH Cancer Center. The intervention will be delivered at MGH Institute of Health Professions (IHP) and investigators at MGH IHP will be involved in recruiting participants and collecting/managing data.

Participants will be enrolled in the study for approximately six months following the schedule below:

* Enrollment into study: HSCT recipients will be recruited into the study approximately six months post HSCT (+/- one month).
* Baseline assessment: To be completed within 3 weeks of completing informed consent.
* WorkS Appointment #1 and #2: To be completed within a 2-month period after completing the baseline assessment. Ideally, the appointments will be approximately one month apart, but can be timed whenever in the 2-month window that is preferred by the participant.
* Exit assessment: To be completed within 3 weeks of completing Appointment 2.
* Final assessment: Return to work status at 12 months post HSCT (+/- three weeks)

Conditions

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Hematopoietic Stem Cell Transplantation

Keywords

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Return to Work

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single arm proof-of-concept trial with up to 35 HSCT survivors reporting employment concerns.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Work Support Intervention

This is a single arm proof-of-concept trial with up to 35 HSCT recipients reporting employment concerns. We will refine and preliminarily evaluate a Work Support (WorkS) self-management intervention designed to catalyze return-to-work self-efficacy.

Group Type EXPERIMENTAL

Work Support (WorkS)

Intervention Type BEHAVIORAL

The WorkS intervention entails two structured visits with a research team member initiated 6-months post-HSCT, which is the earliest point at which most HSCT survivors can safely consider returning to work. The sessions are focused on 1) identifying challenges of navigating work and illness; 2) linking survivors with psychological, rehabilitative, governmental, and community resources that can promote recovery and well-being; and 3) communicating with employers regarding the necessary work modifications to achieve mutual goals.

Interventions

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Work Support (WorkS)

The WorkS intervention entails two structured visits with a research team member initiated 6-months post-HSCT, which is the earliest point at which most HSCT survivors can safely consider returning to work. The sessions are focused on 1) identifying challenges of navigating work and illness; 2) linking survivors with psychological, rehabilitative, governmental, and community resources that can promote recovery and well-being; and 3) communicating with employers regarding the necessary work modifications to achieve mutual goals.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Received an allogeneic HSCT within the past six months to treat a hematological malignancy.
* Screen positive for work-related concerns (i.e., responds "yes" to the question, "Are you concerned about your ability to return to work in the coming six months?")

Exclusion Criteria

* Patients with acute psychiatric or cognitive conditions which the treating clinician believes prohibits informed consent or compliance with the study procedures
* We will not enroll the following special populations: adults unable to consent, individuals not yet adults, pregnant women, and prisoners.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

MGH Institute of Health Professions

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Lyons, ScD, OTR/L

Professor, Occupational Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen Lyons, ScD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

MGH Institute of Health Professions

Locations

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MGH Cancer Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen Lyons, ScD, OTR/L

Role: CONTACT

Phone: 614-643-5372

Email: [email protected]

Facility Contacts

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Sheel Singh, MA

Role: primary

Other Identifiers

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2024P000290

Identifier Type: -

Identifier Source: org_study_id