Clinical trial NCT06494423: Employment Support After Hematopoietic Stem Cell Transplantation
Official title: Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Return to Work
Lead sponsor: MGH Institute of Health Professions
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2024-07-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single arm proof-of-concept trial with up to 35 HSCT survivors reporting employment concerns.
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Screening Rate
timeFrame: At screening
measure: Eligibility Rate
timeFrame: At screening
measure: Enrollment Rate
timeFrame: Up to 2 months
measure: Intervention completion Rate
timeFrame: Up to 2 months
measure: Assessment Completion Rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Working Status
timeFrame: 6 months
measure: Financial Toxicity
timeFrame: 2 months
measure: Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant
timeFrame: 2 months
measure: Return to Work Self-Efficacy
timeFrame: 2 months
measure: Concerns Regarding Work
timeFrame: 2 months
measure: Utility of Intervention
timeFrame: 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Cancer Center
state: Massachusetts
Study officials:
affiliation: MGH Institute of Health Professions
name: Kathleen Lyons, ScD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: