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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930981
• Other study ID #: 2574.00
• Secondary ID: 4R00HL088021-03
• Status: Completed
• Phase: N/A
• First received: August 15, 2013
• Last updated: January 9, 2018
• Start date: October 2012
• Est. completion date: June 2016

Study information

• Verified date: January 2018
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Other Diagnoses, Comorbidities, and Complications

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE)	We will measure toxicities using the NCI CTCAE	at 90 days