Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life

Study Overview
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Brief Summary
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We are interested in studying whether and how medical problems other than primary cancer before hematopoietic cell transplantation would impact the profiles of quality of life and toxicities post-transplantation for patients with blood cancers. We want to see if by assessing comorbidities (such as diabetes) early on, we can identify those patients who will have more toxicities or limitations in their quality of life after transplant. The generated information could set the stage for future intervention studies aiming to improve quality of life for patients with blood cancers after transplantation.

Official Title
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Prospective Assessment of Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life

Conditions
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Hematologic Malignancies, Other Diagnoses, Comorbidities, and Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Allogeneic HCT candidates who are >18 years of age Able to speak and read English Able to provide informed consent Access to a telephone for study-related communications Diagnosed with a hematological malignant disease Willing to complete survey packets at 5 time-points, spanning two years Exclusion Criteria: HCT candidates who are 18 years or younger at the time of study enrollment HCT candidates who cannot read, write, or speak English Patients with diagnoses of non-malignant diseases, or solid tumors are primary disease

Ages Eligible for Study
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Minimum Age: 19 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The MD Anderson Symptom Inventory | A 19-item instrument, it assesses physical symptoms and their interference with life. | Change from Baseline in Symptoms at 3,6,12,and 24 months | 
| The Functional Assessment of Cancer Therapy Bone Marrow Transplant Scale | A 49-item questionnaire measuring quality of life in bone marrow transplant patients, it measures physical, functional, social/family and emotional well-being in addition to bone marrow transplant-specific concerns. | Change from Baseline in Symptoms at 3,6,12,and 24 months | 
| The EQ-5D | This measure is used to measure utilities that can be used to calculate a quality adjusted survival score. | Change from Baseline in Symptoms at 3,6,12,and 24 months | 
| The Social Activity Log | This measure captures the frequency and diversity of social activities outside of daily responsibilities. | Change from Baseline in Symptoms at 3,6,12,and 24 months | 
| ENRICHD Social Support Instrument | This measures social support, including participation in social activities and perception of social support. | Change from Baseline in Symptoms at 3,6,12,and 24 months | 
| The Cancer and Treatment Distress Scale | This is a 25-item scale assessing distress related to perceived demands from events specific to cancer survivors. | Change from Baseline in Symptoms at 3,6,12,and 24 months | 
| The Patient Health Questionnaire-9 | The PHQ-9 measures measures depression and parallels the nine diagnostic symptom criteria of the DSM-IV for Major Depressive Disorder. | Change from Baseline in Symptoms at 3,6,12,and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) | We will measure toxicities using the NCI CTCAE | at 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, toxicities, hematopoietic stem cell transplantation