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

Trial Summary

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 data supports the effectiveness of the treatment Work Support (WorkS) for bone marrow transplant patients?

Research shows that 60% of long-term bone marrow transplant survivors returned to full-time work and 15% to part-time work, indicating that employment support can be beneficial in helping patients resume work after treatment. ^{1 2 3 4 5}

Is the Employment Support for Bone Marrow Transplant treatment safe for humans?

The research articles do not provide specific safety data for the Employment Support for Bone Marrow Transplant treatment or its related interventions. ^{2 3 6 7 8}

How is the Work Support (WorkS) treatment unique for bone marrow transplant patients?

The Work Support (WorkS) treatment is unique because it focuses on helping bone marrow transplant survivors return to work and maintain employment, which is not typically addressed by standard medical treatments. It involves tailored interventions, possibly including vocational components and multidisciplinary support, to address employment challenges specific to these patients. ^{1 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Kathleen Lyons, ScD, OTR/L

Principal Investigator

MGH Institute of Health Professions

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Health, functional status, and employment of adult survivors of bone marrow transplantation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prospective predictors of return to work in the 5 years after hematopoietic cell transplantation. [2022]

3. Netherlands 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Social support and quality of life of patients prior to stem cell or bone marrow transplantation. [2015]

5. England pubmed.ncbi.nlm.nih.gov

A quality of life study in 20 adult long-term survivors of unrelated donor bone marrow transplantation. [2004]

6. England pubmed.ncbi.nlm.nih.gov

Cancer survivors and adverse work outcomes: associated factors and supportive interventions. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Comparing men's and women's experiences of work after cancer: a photovoice study. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Resignation and return to work in patients receiving allogeneic hematopoietic cell transplantation close up. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Return to work experiences of patients treated with stem cell transplantation for a hematologic malignancy. [2020]

10. England 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? [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Recommendations for Research and Practice to Improve Work Outcomes Among Cancer Survivors. [2020]