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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01930981

Enrollment

252

Registered

2013-08-29

Start date

2012-10-31

Completion date

2016-06-30

Last updated

2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies, Other Diagnoses, Comorbidities, and Complications

Keywords

quality of life, toxicities, hematopoietic stem cell transplantation

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

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

Countries

United States

Outcome results