Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- The MD Anderson Symptom Inventory [Change from Baseline in Symptoms at 3,6,12,and 24 months]
A 19-item instrument, it assesses physical symptoms and their interference with life.
- The Functional Assessment of Cancer Therapy Bone Marrow Transplant Scale [Change from Baseline in Symptoms at 3,6,12,and 24 months]
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.
- The EQ-5D [Change from Baseline in Symptoms at 3,6,12,and 24 months]
This measure is used to measure utilities that can be used to calculate a quality adjusted survival score.
- The Social Activity Log [Change from Baseline in Symptoms at 3,6,12,and 24 months]
This measure captures the frequency and diversity of social activities outside of daily responsibilities.
- ENRICHD Social Support Instrument [Change from Baseline in Symptoms at 3,6,12,and 24 months]
This measures social support, including participation in social activities and perception of social support.
- The Cancer and Treatment Distress Scale [Change from Baseline in Symptoms at 3,6,12,and 24 months]
This is a 25-item scale assessing distress related to perceived demands from events specific to cancer survivors.
- The Patient Health Questionnaire-9 [Change from Baseline in Symptoms at 3,6,12,and 24 months]
The PHQ-9 measures measures depression and parallels the nine diagnostic symptom criteria of the DSM-IV for Major Depressive Disorder.
Secondary Outcome Measures
- National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) [at 90 days]
We will measure toxicities using the NCI CTCAE
Eligibility Criteria
Criteria
Inclusion Criteria:
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Allogeneic HCT candidates who are >18 years of age
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Able to speak and read English
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Able to provide informed consent
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Access to a telephone for study-related communications
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Diagnosed with a hematological malignant disease
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Willing to complete survey packets at 5 time-points, spanning two years
Exclusion Criteria:
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HCT candidates who are 18 years or younger at the time of study enrollment
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HCT candidates who cannot read, write, or speak English
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Patients with diagnoses of non-malignant diseases, or solid tumors are primary disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Mohamed L Sorror, MD; MSc, Fred Hutchinson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2574.00
- 4R00HL088021-03