Health TrialsbyHealthPanel

Employment Support After Hematopoietic Stem Cell Transplantation

ConditionHematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMGH Institute of Health Professions

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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?")

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Work Support (WorkS)

    Behavioral

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Work Support InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Screening Rate

Number of patients screened / Number undergoing HSCT during study period

Time frame
At screening
2

Eligibility Rate

Number of patients screening positive \& eligible / Number screened

Time frame
At screening
3

Enrollment Rate

Number of participants who attended the WorkS sessions / Number enrolled; Enrollment rate of at least 50% will indicate feasibility.

Time frame
Up to 2 months
4

Intervention completion Rate

Number of participants who attended the WorkS sessions / Number enrolled; Feasible if at least 80% of participants complete two sessions.

Time frame
Up to 2 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
2 months
3

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.

Time frame
2 months
4

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.

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MGH Institute of Health Professions

Lead sponsor

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov
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