Clinical trial NCT01930981: Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
Official title: Prospective Assessment of Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Malignancies
Other Diagnoses, Comorbidities, and Complications
Keywords: quality of life
toxicities
hematopoietic stem cell transplantation
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-08-29
Enrollment: 252
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hematological malignancies who are being treated with allogeneic hematopoietic cell transplantation (HCT) at the Seattle Cancer Care Alliance.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The MD Anderson Symptom Inventory
timeFrame: Change from Baseline in Symptoms at 3,6,12,and 24 months
measure: The Functional Assessment of Cancer Therapy Bone Marrow Transplant Scale
timeFrame: Change from Baseline in Symptoms at 3,6,12,and 24 months
measure: The EQ-5D
timeFrame: Change from Baseline in Symptoms at 3,6,12,and 24 months
measure: The Social Activity Log
timeFrame: Change from Baseline in Symptoms at 3,6,12,and 24 months
measure: ENRICHD Social Support Instrument
timeFrame: Change from Baseline in Symptoms at 3,6,12,and 24 months
measure: The Cancer and Treatment Distress Scale
timeFrame: Change from Baseline in Symptoms at 3,6,12,and 24 months
measure: The Patient Health Questionnaire-9
timeFrame: Change from Baseline in Symptoms at 3,6,12,and 24 months
Secondary outcomes:
measure: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE)
timeFrame: at 90 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Mohamed L Sorror, MD; MSc
role: PRINCIPAL_INVESTIGATOR
References: