Employment Support After Hematopoietic Stem Cell Transplantation

NCT06494423 | Recruiting

• 1 other identifier: 2024P000290
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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. 1.examining the feasibility and acceptability of the WorkS intervention and the study procedures, and
2. 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

Keywords

Return to Work

Outcome Measures

Primary Outcomes (5)

• Screening Rate

  Number of patients screened / Number undergoing HSCT during study period

  At screening

• Eligibility Rate

  Number of patients screening positive \& eligible / Number screened

  At screening

• Enrollment Rate

  Number of participants who attended the WorkS sessions / Number enrolled; Enrollment rate of at least 50% will indicate feasibility.

  Up to 2 months

• Intervention completion Rate

  Number of participants who attended the WorkS sessions / Number enrolled; Feasible if at least 80% of participants complete two sessions.

  Up to 2 months

• Assessment Completion Rate

  Number participants completing each of the three study assessments/ Number of participants enrolled

  Up to 6 months

Secondary Outcomes (6)

• Working Status

  6 months

• Financial Toxicity

  2 months

• Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant

  2 months

• Return to Work Self-Efficacy

  2 months

• Concerns Regarding Work

  2 months

Study Arms (1)

Work Support Intervention

EXPERIMENTAL

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.

Behavioral: Work Support (WorkS)

Interventions

Work Support (WorkS) 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.

Work Support Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?")

You may not qualify if:

• 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.

Sponsors & Collaborators

• MGH Institute of Health Professions: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

MGH Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Study Officials

• Kathleen Lyons, ScD, OTR/L

  MGH Institute of Health Professions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Lyons, ScD, OTR/L

CONTACT

614-643-5372; klyons2@mghihp.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Occupational Therapy

Model Details: A single arm proof-of-concept trial with up to 35 HSCT survivors reporting employment concerns.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)