Hematopoietic/Lymphoid CancerNCT01758484
Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant
A study testing palliative care, questionnaire administration and quality-of-life assessment in people with Hematopoietic/Lymphoid Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of life in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic/Lymphoid Cancer
- What is being tested?
- palliative care, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- English as primary language
- Planned autologous or allogeneic hematopoietic cell transplantation
- Presence of co-morbidities (hematopoietic cell transplant co-morbidity index [HCT-CI] score 3 or greater), high risk disease (relapse risk > 25%), or a planned type of transplant (human leukocyte antigen [HLA]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse
Who cannot join
- Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
- First transplant of a planned tandem procedure (the second transplant is eligible)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: FEASIBILITY OF IMPLEMENTING PRE-TRANSPLANT EVALUATION BY THE SUPPORTIVE CARE TEAM FOR PATIENTS UNDERGOING HEMATOPOIETIC CELL TRANSPLANTATION FOR HEMATOLOGICAL MALIGNANCIES
This pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of life in this patient population.
Read the detailed description
PRIMARY OBJECTIVES:
- Pilot a supportive care intervention that begins prior to transplantation and continues through the acute peritransplant period.
II. Determine the proportion of patients who enroll and the level of comfort / distress of hematopoietic cell transplant (HCT) patients who meet with the supportive care team.
III. Pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial.
OUTLINE:
Patients undergo supportive care consultation before transplantation and at least once monthly while they remain at the transplant center.
- Conditions
- Hematopoietic/Lymphoid Cancer
- Being tested
- palliative care, questionnaire administration, quality-of-life assessment
- Keywords
- Hematopoietic cell transplantation, Supportive/palliative care
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palliative careOther
Undergo supportive care intervention
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (palliative care support) | Experimental | Patients undergo palliative care support before transplantation and at least once monthly while they remain at the transplant center. Receives: Other: palliative care; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study participation rates defined as the proportion of patients who consent to enroll
Will mainly be descriptive.
Measured: Up to 5 months
Completion time for the supportive care consultation
Will mainly be descriptive.
Measured: Up to 90 days post-treatment
Level of comfort / distress attributed to individual parts of the consultation
Will mainly be descriptive. The post-consultation scores measuring level of comfort or distress per topic in the supportive care consultation will be summarized per item.
Measured: Up to 90 days post-treatment
Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point
Will mainly be descriptive. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales vs. scales attempted to be collected or completed by patients.
Measured: Up to 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic/Lymphoid CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie Lee, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758484
- Sponsor's protocol ID
- 2659.00
- Other IDs
- NCI-2012-03009, P30CA015704
- Status last verified
- Feb 2016
- First submitted
- 27 Dec 2012
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEASIBILITY OF IMPLEMENTING PRE-TRANSPLANT EVALUATION BY THE SUPPORTIVE CARE TEAM FOR PATIENTS UNDERGOING HEMATOPOIETIC CELL TRANSPLANTATION FOR HEMATOLOGICAL MALIGNANCIES
- ClinicalTrials.gov ID
- NCT01758484
- Acronym / sponsor ID
- 2659.00
- Conditions
- Hematopoietic/Lymphoid Cancer
- Keywords
- Hematopoietic cell transplantation, Supportive/palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- First posted
- 1 Jan 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.
This pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of life in this patient population.
Detailed description
PRIMARY OBJECTIVES:
- Pilot a supportive care intervention that begins prior to transplantation and continues through the acute peritransplant period.
II. Determine the proportion of patients who enroll and the level of comfort / distress of hematopoietic cell transplant (HCT) patients who meet with the supportive care team.
III. Pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial.
OUTLINE:
Patients undergo supportive care consultation before transplantation and at least once monthly while they remain at the transplant center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (palliative care support) | Experimental | Other: palliative care, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients undergo palliative care support before transplantation and at least once monthly while they remain at the transplant center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- English as primary language
- Planned autologous or allogeneic hematopoietic cell transplantation
- Presence of co-morbidities (hematopoietic cell transplant co-morbidity index [HCT-CI] score 3 or greater), high risk disease (relapse risk > 25%), or a planned type of transplant (human leukocyte antigen [HLA]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse
Key exclusion criteria (2 listed)
- Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
- First transplant of a planned tandem procedure (the second transplant is eligible)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palliative careUndergo supportive care intervention | Other | Supportive care (palliative care support) |
| questionnaire administrationAncillary studies | Other | Supportive care (palliative care support) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive care (palliative care support) |
Primary outcome
Study participation rates defined as the proportion of patients who consent to enroll
Time frame: Up to 5 months
Will mainly be descriptive.
Completion time for the supportive care consultation
Time frame: Up to 90 days post-treatment
Will mainly be descriptive.
Level of comfort / distress attributed to individual parts of the consultation
Time frame: Up to 90 days post-treatment
Will mainly be descriptive. The post-consultation scores measuring level of comfort or distress per topic in the supportive care consultation will be summarized per item.
Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point
Time frame: Up to 90 days post-treatment
Will mainly be descriptive. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales vs. scales attempted to be collected or completed by patients.
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 2 Mar 2016.
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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.
Stephanie Lee principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palliative care, questionnaire administration and quality-of-life assessment in people with Hematopoietic/Lymphoid Cancer, 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 4 inclusion and 2 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 2 Mar 2016. 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?
Study participation rates defined as the proportion of patients who consent to enroll (time frame: Up to 5 months). The study lists 4 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 2 Mar 2016.