Employment Support After Hematopoietic Stem Cell Transplantation
NCT Number: NCT06494423
Acronym: WorkS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic Stem Cell Transplantation
Interventions: BEHAVIORAL: Work Support (WorkS)
Sponsor: MGH Institute of Health Professions
Collaborators: Massachusetts General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2025-06

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.

Primary Outcome Measures: Screening Rate, Number of patients screened / Number undergoing HSCT during study period, At screening|Eligibility Rate, Number of patients screening positive \& eligible / Number screened, At screening|Enrollment Rate, Number of participants who attended the WorkS sessions / Number enrolled; Enrollment rate of at least 50% will indicate feasibility., 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., Up to 2 months|Assessment Completion Rate, Number participants completing each of the three study assessments/ Number of participants enrolled, Up to 6 months
Secondary Outcome Measures: 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., 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., 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., 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., 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)?", 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.", 2 months