Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Return to Work
Brief 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. 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
BEHAVIORALWork 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.
Sponsors
Massachusetts General Hospital
MGH Institute of Health Professions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A single arm proof-of-concept trial with up to 35 HSCT survivors reporting employment concerns.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention completion Rate | 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 | Up to 6 months | Number participants completing each of the three study assessments/ Number of participants enrolled |
| Screening Rate | At screening | Number of patients screened / Number undergoing HSCT during study period |
| Eligibility Rate | At screening | Number of patients screening positive & eligible / Number screened |
| Enrollment Rate | Up to 2 months | Number of participants who attended the WorkS sessions / Number enrolled; Enrollment rate of at least 50% will indicate feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Working Status | 6 months | 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. |
| Utility of Intervention | 2 months | 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. |
| Financial Toxicity | 2 months | 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. |
| Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant | 2 months | 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. |
| Return to Work Self-Efficacy | 2 months | 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. |
| Concerns Regarding Work | 2 months | 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)? |
Countries
United States
Contacts
Primary ContactKathleen Lyons, ScD, OTR/L
Outcome results
None listed