Employment Support for Bone Marrow Transplant

(WorkS Trial)

Overseen By Kathleen Lyons, ScD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MGH Institute of Health Professions

Disqualifiers: Acute psychiatric, Cognitive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have undergone a bone marrow transplant in returning to work. It centers on a support program called Work Support (WorkS), which seeks to boost confidence in resuming work, enhance quality of life, and reduce financial stress. Participants include those who had a stem cell transplant in the last six months and are concerned about returning to their jobs. The trial's goal is to determine if the support program is helpful and practical. As an unphased trial, it provides a unique opportunity to access a potentially beneficial support program tailored to participants' needs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this Work Support intervention is safe?

Research has shown that many people struggle to return to work after a bone marrow transplant. This study tests a Work Support (WorkS) program designed to address these challenges. The program aims to boost confidence, improve work status, enhance quality of life, and address financial concerns.

The WorkS program is not a medical treatment, so it is generally safe. It provides support and resources without using medications or medical procedures. No reports of negative effects have emerged from this type of support program, indicating it is usually well-received and lacks known physical side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Work Support (WorkS) intervention because it offers a novel approach to help bone marrow transplant recipients return to work with confidence. Unlike traditional methods, which may not specifically address employment concerns, WorkS is a self-management tool designed to boost self-efficacy for returning to work. This intervention is unique because it directly targets the psychological and practical challenges that patients face when resuming employment, potentially leading to better work-related outcomes and improved quality of life.

What evidence suggests that this Work Support intervention is effective for improving return-to-work outcomes after bone marrow transplant?

Research has shown that social support is crucial for a successful recovery after a stem cell transplant. One study found that sharing experiences and caring for each other improves the quality of life and health for those who have undergone this procedure. Another study highlighted that peer support can assist patients with blood cancers during their transplant journey. Including social work throughout the transplant process provides valuable support to both patients and caregivers. This support can boost confidence in returning to work and help reduce financial stress. In this trial, the Work Support (WorkS) program is designed to leverage these benefits to help individuals return to work after their transplant. ^{6 7 8 9 10}

Who Is on the Research Team?

Kathleen Lyons, ScD, OTR/L

Principal Investigator

MGH Institute of Health Professions

Are You a Good Fit for This Trial?

This trial is for individuals who had a bone marrow transplant to treat blood cancer within the last six months and are worried about returning to work. It's not suitable for those without work-related concerns.

Inclusion Criteria

I am worried about my ability to go back to work in the next six months.

I had a bone marrow transplant from a donor within the last 6 months for blood cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 1 month

Enrollment

HSCT recipients are recruited into the study approximately six months post HSCT

1 month

Baseline Assessment

Baseline assessment to be completed within 3 weeks of completing informed consent

3 weeks

WorkS Intervention

Participants complete two WorkS appointments within a 2-month period after baseline assessment

2 months

Exit Assessment

Exit assessment to be completed within 3 weeks of completing Appointment 2

3 weeks

Final Assessment

Return to work status assessed at 12 months post HSCT

12 months post HSCT

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Work Support (WorkS)

Trial Overview The study tests a 'Work Support' program aimed at helping patients overcome challenges when going back to work after their transplant. It checks if the program is doable, acceptable, and potentially effective in boosting confidence, job status, life quality, and reducing money worries.

How Is the Trial Designed?

Group I: Work Support Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials

19

Recruited

2,200+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Hematopoietic stem cell transplantation (HSCT) survivors often face a complex and prolonged return to work (RTW process), with many experiencing incomplete work hours or responsibilities due to the long-term effects of their treatment.

Key barriers to RTW include the lingering side effects of cancer treatment and health issues prior to diagnosis, while facilitators include financial incentives and support from family and peers; proposed solutions involve better communication about RTW during hospital care and enhanced employer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return to work experiences of patients treated with stem cell transplantation for a hematologic malignancy. Persoon, S., Buffart, LM., Chinapaw, MJM., et al.[2020]

Cancer survivors face various challenges in the workplace, including prolonged sick leave and unemployment, influenced by factors like cancer type, treatment, fatigue, and cognitive functioning.

Supportive interventions, particularly physical and multicomponent programs, can effectively aid cancer survivors in returning to work, but more research is needed to determine the best timing and to focus on vulnerable groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer survivors and adverse work outcomes: associated factors and supportive interventions. de Boer, AGEM., de Wind, A., Coenen, P., et al.[2023]

A review of 18 studies on interventions for chronically ill employees found that vocational and multidisciplinary approaches, especially those involving professional trainers, were most effective in helping individuals retain their jobs.

The findings suggest that tailored interventions for cancer survivors should include shared goal setting and vocational components to enhance their employability, although small sample sizes in the studies may limit the precision of these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of interventions to retain chronically ill occupationally active employees in work: can findings be transferred to cancer survivors? Stapelfeldt, CM., Klaver, KM., Rosbjerg, RS., et al.[2019]

Longitudinal studies are essential to understand how various patient characteristics and work experiences affect employment outcomes for cancer survivors, highlighting the need for targeted interventions.

Research should focus on improving communication between healthcare providers and patients regarding employment concerns, as well as developing training programs for employers to better support cancer survivors in the workplace.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for Research and Practice to Improve Work Outcomes Among Cancer Survivors. de Moor, JS., Alfano, CM., Kent, EE., et al.[2020]

The GIRONA intervention, designed to provide work-related support for patients with gastrointestinal cancer, was generally perceived as positive and feasible by both patients (23 participants) and healthcare professionals (18 providers).

Despite the positive feedback, barriers such as consultation length and timing of support initiation were identified, indicating that while the intervention is effective, there is room for improvement in its implementation to better meet patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is a tailored work-related support intervention feasible in everyday clinical practice? The experience of healthcare professionals and patients with cancer. Zaman, AGNM., Tytgat, KMAJ., Klinkenbijl, JHG., et al.[2021]

In a study of 282 patients undergoing bone marrow transplantation, those with partners reported significantly higher levels of positive social support, which is crucial for emotional well-being during treatment.

The research identified that problematic social support negatively impacts emotional and social functioning, highlighting the importance of healthy support systems for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social support and quality of life of patients prior to stem cell or bone marrow transplantation. Frick, E., Ramm, G., Bumeder, I., et al.[2015]

Among 197 adults who underwent hematopoietic cell transplantation, those with better physical function (PCS >40) returned to work significantly faster, with a hazard ratio of 2.38, indicating a strong link between physical health and work reintegration.

Female cancer survivors were less likely to return to full-time work compared to males, with a hazard ratio of 0.54, highlighting the need for targeted support for women in the recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective predictors of return to work in the 5 years after hematopoietic cell transplantation. Kirchhoff, AC., Leisenring, W., Syrjala, KL.[2022]

A study of 20 long-term survivors of unrelated donor bone marrow transplantation (UD-BMT) revealed that while overall life satisfaction was above average, many survivors expressed dissatisfaction with their physical strength and appearance.

60% of survivors returned to full-time work and 15% to part-time work post-transplant, indicating a significant number were able to reintegrate into the workforce, regardless of complications like graft-versus-host disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality of life study in 20 adult long-term survivors of unrelated donor bone marrow transplantation. Marks, DI., Gale, DJ., Vedhara, K., et al.[2004]

A study of 135 adults who survived bone marrow transplantation found that 93% reported being able to perform normal activities with minor or no physical problems, indicating a high level of functional ability post-transplant.

Approximately 65% of participants had returned to full- or part-time employment, and 67% described their overall health as good to excellent, suggesting that bone marrow transplant survivors can achieve quality of life comparable to those who have undergone less intensive cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health, functional status, and employment of adult survivors of bone marrow transplantation. Wingard, JR., Curbow, B., Baker, F., et al.[2022]

A study involving 20 cancer survivors (10 men and 10 women) revealed that both genders face unique challenges and motivations when reintegrating into the workforce after treatment.

Men tend to prefer active engagement and productivity in their work integration, while women are more likely to use conversation as a coping mechanism, suggesting that tailored rehabilitation strategies could improve support for male survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing men's and women's experiences of work after cancer: a photovoice study. Morrison, TL., Thomas, RL.[2018]

In a survey of 1048 allogeneic hematopoietic cell transplantation (allo-HCT) survivors, 41% resigned from their jobs after diagnosis, with the highest rate of resignations occurring after discharge from the hospital.

Workplace accommodations significantly improved the chances of returning to work, with 76% of those receiving accommodations able to return compared to only 52% without any accommodations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resignation and return to work in patients receiving allogeneic hematopoietic cell transplantation close up. Kurosawa, S., Yamaguchi, T., Mori, A., et al.[2022]

Citations

1. astctjournal.org astctjournal.org/article/S2666-6367(24)00689-4/fulltext

A Peer Support Intervention in Patients With Hematologic ... Sharing and caring: The impact of social support on quality of life and health outcomes in hematopoietic stem cell transplantation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9119381/

Peer support in patients with hematologic malignancies ... Peer support in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): a qualitative study

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666636725011030

Integrating Social Work Throughout the Hematopoietic Cell ... The gold standard model of psychosocial care integrates social work throughout HCT. In the model, social workers proactively follow all patients and caregivers.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11195819/

Support interventions offered to family members of a child ... A scoping review was conducted to explore support interventions for family members of a child treated with hematopoietic stem cell transplant (HSCT).

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33455

The impact of social support on quality of life and health ... Social support is crucial for successful recovery after hematopoietic stem cell transplantation (HSCT) and has the potential to affect patient quality of life ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06494423

Study Details | NCT06494423 | Employment Support After ... exploring the preliminary effects of WorkS for improving patient-reported return-to-work self-efficacy, work status, quality of life, and financial toxicity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6597586/

Return to work experiences of patients treated with stem ... This qualitative study aimed to identify hematopoietic stem cell transplantation (HSCT) survivors' (1) work perceptions; (2) barriers to and facilitators of ...

8. astctjournal.org astctjournal.org/article/S1083-8791(20)30233-0/fulltext

Return-to-Work Guidelines and Programs for Post- ... All centers recommend RTW at 6 months or less after HCT for their auto-HCT recipients; recommendations for allo-HCT recipients ranged from 4 months to >1 year ...

9. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13898-3

Rehabilitation after bone marrow transplant compared with ... The primary aim of this study is to investigate the effectiveness of an eight-week multidisciplinary rehabilitation intervention compared with usual care.

10. sciencedirect.com sciencedirect.com/science/article/pii/S2666636722000604

Review Quality Improvement in Hematopoietic Stem Cell ... The Model for Improvement is a robust quality improvement tool that transplant and cellular therapy teams can use to redesign healthcare processes.