Employment Support After Hematopoietic Stem Cell Transplantation (WorkS)

Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Behavioral: Work Support (WorkS)

Detailed 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)

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen Lyons, ScD, OTR/L; Phone Number: 614-643-5372; Email: klyons2@mghihp.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • MGH Cancer Center
      • Contact: Sheel Singh, MA; Phone Number: 617-398-7608; Email: ssingh@mghihp.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working Status	We will ask questions about the work status at the time of diagnosis, including the job title, average number of hours worked per week, the number of years at that worksite, the degree to which they get support from superiors at work, the flexibility of their workplace, the importance of and motivation for work, the degree to which their job is physically demanding, the degree to which their job is cognitively demanding, and the degree to which their job is psychologically demanding. We will also ask about the degree of certainty that the participant will return to the same job once they are cleared to return to work and the estimated timeframe for return to work.	6 months
Financial Toxicity	We will use the Functional Assessment of Chronic Illness Therapy-Comprehensive Score of Financial Toxicity (FACIT-COST) questionnaire to assess financial distress. The FACIT-COST is a 12-item patient-reported outcome measure that describes financial distress experienced by patients with cancer.	2 months
Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant	We will use the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale to assess quality of life. The FACT-BMT is a 50-item, patient-reported measure that describes five dimensions of quality of life in bone marrow transplant patients: social well-being, physical well-being, functional well-being, emotional well-being and transplant-specific concerns.	2 months
Return to Work Self-Efficacy	The 11-item Return to Work Self-Efficacy Scale (RTWSE-11)[16] quantifies an individual's confidence in their ability to work fully and perform work tasks.	2 months
Concerns Regarding Work	We will ask the following open-ended question and record the response verbatim: "What concerns do you have about returning to work (either your previous job or if you seek or find a new job)?"	2 months
Utility of Intervention	Participants will rate their degree of agreement with statements regarding the utility of the workbook and the consultation. They will rate agreement on a five point scale where "1" is "strongly disagree" and "5" is "strongly agree."	2 months

Collaborators and Investigators

• Sponsor: MGH Institute of Health Professions
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Kathleen Lyons, ScD, OTR/L, MGH Institute of Health Professions

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Return to Work
• Other Study ID Numbers: 2024P000290

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No