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NCT Number: NCT06494423

Employment Support After Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MGH Cancer Center

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Sheel Singh, MA

CONTACT

[email protected]

617-398-7608

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Screening Rate

    Time frame: At screening

    Number of patients screened / Number undergoing HSCT during study period

  2. Eligibility Rate

    Time frame: At screening

    Number of patients screening positive & eligible / Number screened

  3. Enrollment Rate

    Time frame: Up to 2 months

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

  4. Intervention completion Rate

    Time frame: Up to 2 months

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

  5. Assessment Completion Rate

    Time frame: Up to 6 months

    Number participants completing each of the three study assessments/ Number of participants enrolled

Secondary outcomes

  1. Working Status

    Time frame: 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.

  2. Financial Toxicity

    Time frame: 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.

  3. Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant

    Time frame: 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.

  4. Return to Work Self-Efficacy

    Time frame: 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.

  5. Concerns Regarding Work

    Time frame: 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)?"

  6. Utility of Intervention

    Time frame: 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Lyons, ScD, OTR/L

CONTACT

[email protected]

614-643-5372

Sponsors and collaborators

Lead sponsor

MGH Institute of Health Professions

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation

Acronym: WorkS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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