Chronic Myeloproliferative DisordersNCT00281814
Caregiver Support in the Coping of Patients Who Are Undergoing a Donor Bone Marrow Transplant
An observational study of Chronic Myeloproliferative Disorders and Leukemia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
RATIONALE: Questionnaires that measure coping may improve the ability to plan supportive care for patients undergoing donor bone marrow transplant. PURPOSE: This clinical trial is studying coping in patients who are undergoing a donor bone marrow transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2006to 4 Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Local patients receiving allogeneic bone marrow transplant.
DISEASE CHARACTERISTICS:
- Medically suitable for allogeneic bone marrow transplantation
PATIENT CHARACTERISTICS:
- Resides locally in the Cleveland, Ohio area
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Adjustment to Illness by Survival Rates in Allogeneic Bone Marrow Transplant (BMT): The Relative Importance of Lay Care-Partner Support
RATIONALE: Questionnaires that measure coping may improve the ability to plan supportive care for patients undergoing donor bone marrow transplant.
PURPOSE: This clinical trial is studying coping in patients who are undergoing a donor bone marrow transplant.
Read the detailed description
OBJECTIVES:
- Investigate the relative importance of having a consistent inpatient lay care-partner for patients undergoing allogeneic bone marrow transplantation, in terms of the effects on modes of adjustment to illness and survival.
OUTLINE: Patients undergo a 40-minute recorded oral interview in person to provide personal and social demographic data using a 20-item questionnaire (The Adjustment to Illness Questionnaire-Bone Marrow Transplantation) at baseline (pre-transplant) and at day 100 post-transplant.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Being tested
- psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, atypical chronic myeloid leukemia, blastic phase chronic myelogenous leukemia, chronic idiopathic myelofibrosis, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, de novo myelodysplastic syndromes, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, myelodysplastic/myeloproliferative disease, unclassifiable, nodal marginal zone B-cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
psychosocial assessment and care
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare modes of illness adjustment, presence or absence of an inpatient lay care-partner, and survival rates
Measured: Through 100 days post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study start1 Feb 2006
- Primary completion31 Dec 2008
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Navneet Majhail, MD, The Cleveland Clinic
- Investigators
- Brian J. Bolwell, MD, Study chair, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281814
- Sponsor's protocol ID
- CASE-CCF-6950
- Other IDs
- P30CA043703, CASE-CCF-6950, CASE-CCF-1035
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2006
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustment to Illness by Survival Rates in Allogeneic Bone Marrow Transplant (BMT): The Relative Importance of Lay Care-Partner Support
- ClinicalTrials.gov ID
- NCT00281814
- Acronym / sponsor ID
- CASE-CCF-6950
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Keywords
- psychosocial effects of cancer and its treatment, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2006 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 25 Jan 2006 (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.
RATIONALE: Questionnaires that measure coping may improve the ability to plan supportive care for patients undergoing donor bone marrow transplant.
PURPOSE: This clinical trial is studying coping in patients who are undergoing a donor bone marrow transplant.
Detailed description
OBJECTIVES:
- Investigate the relative importance of having a consistent inpatient lay care-partner for patients undergoing allogeneic bone marrow transplantation, in terms of the effects on modes of adjustment to illness and survival.
OUTLINE: Patients undergo a 40-minute recorded oral interview in person to provide personal and social demographic data using a 20-item questionnaire (The Adjustment to Illness Questionnaire-Bone Marrow Transplantation) at baseline (pre-transplant) and at day 100 post-transplant.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Local patients receiving allogeneic bone marrow transplant.
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 |
|---|---|---|
| psychosocial assessment and carepsychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Compare modes of illness adjustment, presence or absence of an inpatient lay care-partner, and survival rates
Time frame: Through 100 days post transplant
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 26 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.
Brian J. Bolwell, MD study chair
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive 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 Chronic Myeloproliferative Disorders and Leukemia, run by The Cleveland Clinic 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?
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 26 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?
Compare modes of illness adjustment, presence or absence of an inpatient lay care-partner, and survival rates (time frame: Through 100 days post transplant). 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 26 Jan 2018.