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

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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancies; Other Diagnoses, Comorbidities, and Complications

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Mohamed L Sorror, MD; MSc, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 15, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; hematopoietic stem cell transplantation; toxicities
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 2574.00; 4R00HL088021-03 (U.S. NIH Grant/Contract)