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NCT Number: NCT01930981

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.

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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Other Diagnoses, Comorbidities, and Complications

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The MD Anderson Symptom Inventory

    Time frame: 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.

  2. The Functional Assessment of Cancer Therapy Bone Marrow Transplant Scale

    Time frame: 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.

  3. The EQ-5D

    Time frame: 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.

  4. The Social Activity Log

    Time frame: 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.

  5. ENRICHD Social Support Instrument

    Time frame: 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.

  6. The Cancer and Treatment Distress Scale

    Time frame: 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.

  7. The Patient Health Questionnaire-9

    Time frame: 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.

Secondary outcomes

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

    Time frame: at 90 days

    We will measure toxicities using the NCI CTCAE

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2013
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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