Employment Support After Hematopoietic Stem Cell Transplantation (WorkS)

MGH Institute of Health Professions

Status: Enrolling

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Behavioral: Work Support (WorkS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06494423

2024P000290

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Work Support Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Work Support (WorkS)