Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant

Study Overview
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Brief Summary
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This pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of life in this patient population.

Detailed Description
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PRIMARY OBJECTIVES: I. Pilot a supportive care intervention that begins prior to transplantation and continues through the acute peritransplant period. II. Determine the proportion of patients who enroll and the level of comfort / distress of hematopoietic cell transplant (HCT) patients who meet with the supportive care team. III. Pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial. OUTLINE: Patients undergo supportive care consultation before transplantation and at least once monthly while they remain at the transplant center.

Official Title
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FEASIBILITY OF IMPLEMENTING PRE-TRANSPLANT EVALUATION BY THE SUPPORTIVE CARE TEAM FOR PATIENTS UNDERGOING HEMATOPOIETIC CELL TRANSPLANTATION FOR HEMATOLOGICAL MALIGNANCIES

Conditions
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Hematopoietic/Lymphoid Cancer

Intervention / Treatment
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* Other: palliative care
* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent English as primary language Planned autologous or allogeneic hematopoietic cell transplantation Presence of co-morbidities (hematopoietic cell transplant co-morbidity index [HCT-CI] score 3 or greater), high risk disease (relapse risk > 25%), or a planned type of transplant (human leukocyte antigen [HLA]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse Exclusion Criteria: Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team First transplant of a planned tandem procedure (the second transplant is eligible)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (palliative care support)<br>Patients undergo palliative care support before transplantation and at least once monthly while they remain at the transplant center. | Other: palliative care<br>* Undergo supportive care intervention<br>Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study participation rates defined as the proportion of patients who consent to enroll | Will mainly be descriptive. | Up to 5 months | 
| Completion time for the supportive care consultation | Will mainly be descriptive. | Up to 90 days post-treatment | 
| Level of comfort / distress attributed to individual parts of the consultation | Will mainly be descriptive. The post-consultation scores measuring level of comfort or distress per topic in the supportive care consultation will be summarized per item. | Up to 90 days post-treatment | 
| Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point | Will mainly be descriptive. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales vs. scales attempted to be collected or completed by patients. | Up to 90 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic cell transplantation, Supportive/palliative care