Hematologic MalignanciesNCT01930981
Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
An observational study of Hematologic Malignancies and Other Diagnoses, Comorbidities, and Complications, run by Fred Hutchinson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hematologic Malignancies, Other Diagnoses, Comorbidities, and Complications
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with hematological malignancies who are being treated with allogeneic hematopoietic cell transplantation (HCT) at the Seattle Cancer Care Alliance.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: 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.
- Keywords
- quality of life, toxicities, hematopoietic stem cell transplantation
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The MD Anderson Symptom Inventory
A 19-item instrument, it assesses physical symptoms and their interference with life.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
We will measure toxicities using the NCI CTCAE
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mohamed L Sorror, MD; MSc, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930981
- Sponsor's protocol ID
- 2574.00
- Other IDs
- 4R00HL088021-03
- Status last verified
- Jan 2018
- First submitted
- 15 Aug 2013
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
- ClinicalTrials.gov ID
- NCT01930981
- Acronym / sponsor ID
- 2574.00
- Keywords
- quality of life, toxicities, hematopoietic stem cell transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with hematological malignancies who are being treated with allogeneic hematopoietic cell transplantation (HCT) at the Seattle Cancer Care Alliance.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: at 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed L Sorror, MD; MSc principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancies and Other Diagnoses, Comorbidities, and Complications, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MD Anderson Symptom Inventory (time frame: Change from Baseline in Symptoms at 3,6,12,and 24 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.