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

NCT01930981 | Completed

• 2 other identifiers: 2574.004R00HL088021-03
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies; Other Diagnoses, Comorbidities, and Complications

Keywords

quality of life; toxicities; hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE)

  at 90 days

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mohamed L Sorror, MD; MSc

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 29, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

US (1)