Recruiting

Observational Study

Sponsor:

MGH Institute of Health Professions

Code:

NCT06494423

Conditions

Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Work Support (WorkS)

Study Details

Brief summary:

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.

Conditions

Hematopoietic Stem Cell Transplantation

Study ID

NCT06494423

Start date

Jul 31, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Screening Rate [ Time Frame: At screening ]
  • Eligibility Rate [ Time Frame: At screening ]
  • Enrollment Rate [ Time Frame: Up to 2 months ]
  • Intervention completion Rate [ Time Frame: Up to 2 months ]
  • Assessment Completion Rate [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Kathleen Lyons, ScD, OTR/L

614-643-5372klyons2@mghihp.edu

Locations

MGH Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sheel Singh, MA

617-398-7608ssingh@mghihp.edu

More Information

Sponsor

MGH Institute of Health Professions

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • Return to Work

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MGH Institute of Health Professions on 2025-12-19.