Employment Support After Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Work Support (WorkS).
- Who it may be relevant to
- Registry conditions: Hematopoietic Stem Cell Transplantation. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation
Overview
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
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)
Interventions
- 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 modif
Primary outcome measures
- 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]
Secondary outcome measures (6)
- Working Status [Time frame: 6 months]
- Financial Toxicity [Time frame: 2 months]
- Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant [Time frame: 2 months]
- Return to Work Self-Efficacy [Time frame: 2 months]
- Concerns Regarding Work [Time frame: 2 months]
- Utility of Intervention [Time frame: 2 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MGH Cancer Center — Boston
Identifiers
NCT: NCT06494423 · 2024P000290