Hematopoietic Stem Cell TransplantationWorkSNCT06494423
Employment Support After Hematopoietic Stem Cell Transplantation
A study testing Work Support (WorkS) in people with Hematopoietic Stem Cell Transplantation, run by MGH Institute of Health Professions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Work Support (WorkS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?")
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MGH Cancer Center
Boston, Massachusetts, 02114
Sheel Singh, MA, 617-398-7608, ssingh@mghihp.edu
About this study
Official title: 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:
- examining the feasibility and acceptability of the WorkS intervention and the study procedures, and
- exploring the preliminary effects of WorkS for improving patient-reported return-to-work self-efficacy, work status, quality of life, and financial toxicity.
Read the 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)
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Work Support (WorkS)
- Keywords
- Return to Work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work Support (WorkS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Work Support (WorkS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Rate
Number of patients screened / Number undergoing HSCT during study period
Measured: At screening
Eligibility Rate
Number of patients screening positive \& eligible / Number screened
Measured: At screening
Enrollment Rate
Number of participants who attended the WorkS sessions / Number enrolled; Enrollment rate of at least 50% will indicate feasibility.
Measured: 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.
Measured: Up to 2 months
Assessment Completion Rate
Number participants completing each of the three study assessments/ Number of participants enrolled
Measured: Up to 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)?"
Measured: 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."
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start31 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm proof-of-concept trial with up to 35 HSCT survivors reporting employment concerns.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Kathleen Lyons, ScD, OTR/L, MGH Institute of Health Professions
- Investigators
- Kathleen Lyons, ScD, OTR/L, Principal investigator, MGH Institute of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494423
- Sponsor's protocol ID
- 2024P000290
- Acronym
- WorkS
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06494423
- Acronym / sponsor ID
- WorkS / 2024P000290
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Return to Work
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- examining the feasibility and acceptability of the WorkS intervention and the study procedures, and
- 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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm proof-of-concept trial with up to 35 HSCT survivors reporting employment concerns.
| Arm | Type | Receives |
|---|---|---|
| Work Support Intervention | Experimental | Behavioral: Work Support (WorkS)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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?")
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Work Support Intervention |
Primary outcome
Screening Rate
Time frame: At screening
Number of patients screened / Number undergoing HSCT during study period
Eligibility Rate
Time frame: At screening
Number of patients screening positive \& eligible / Number screened
Enrollment Rate
Time frame: Up to 2 months
Number of participants who attended the WorkS sessions / Number enrolled; Enrollment rate of at least 50% will indicate feasibility.
Intervention completion Rate
Time frame: Up to 2 months
Number of participants who attended the WorkS sessions / Number enrolled; Feasible if at least 80% of participants complete two sessions.
Assessment Completion Rate
Time frame: Up to 6 months
Number participants completing each of the three study assessments/ Number of participants enrolled
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Related trials for Hematopoietic Stem Cell Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Lyons, ScD, OTR/L principal investigator
MGH Institute of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Work Support (WorkS) in people with Hematopoietic Stem Cell Transplantation, run by MGH Institute of Health Professions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Lyons, ScD, OTR/L (614-643-5372, klyons2@mghihp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening Rate (time frame: At screening). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.