Hodgkin's DiseaseBMT/SCTNCT00579917
Behavioral Intervention For BMT/SCT Survivors
An observational study of Hodgkin's Disease and Leukemia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to understand how to help survivors of bone marrow transplant and stem cell transplant (BMT/SCT) with emotional distress. BMT/SCT has become a more common type of treatment for cancer or hematological disorder (blood disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Disease, Leukemia, Multiple Myeloma
- What is being tested?
- Cognitive Behavioral Therapy: Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2008
- 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: Primary care clinics
Who may be able to join
- Have significant psychological distress measured by either:
- PTSD ONLY - score of 1.0 standard deviation above the mean on the PTSD Checklist-Civilian (PCL-C), or score meets PCL-C symptom cluster criteria for 3 symptom clusters (i.e. re-experiencing, numbing and avoidance combined, and hyperarousal) or 4 symptom clusters (i.e., re-experiencing, numbing only, avoidance only, and hyperarousal); or
- DISTRESS WITH SOME PTSD - score meets clinically significant impairment on the Brief Symptom Inventory (BSI) global distress index and score meets PCL-C symptom cluster criteria for at least one PCL-C symptom cluster of 3 symptom clusters (i.e. re-experiencing, numbing and avoidance combined, and hyperarousal) or 4 symptom clusters (i.e., re-experiencing, numbing only, avoidance only, and hyperarousal)
- Do not have a substance abuse disorder
- Do not have cognitive impairment as indicated by a score of 3 or lower on the Mini-Mental Status Exam
- Absence of psychotic symptomatology
- Do not have active suicidal ideation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward
The purpose of this study is to understand how to help survivors of bone marrow transplant and stem cell transplant (BMT/SCT) with emotional distress. BMT/SCT has become a more common type of treatment for cancer or hematological disorder (blood disease). For this reason, there is concern that adjustment after treatment may be difficult for many persons. We have found that about 25% of BMT/SCT survivors still feel anxious and distressed about their illness and its treatment after at least one year following transplant. This study is one of the first to study the impact of counseling on BMT/SCT survivors. The study is being carried out at Memorial Sloan-Kettering Cancer Center, Mount Sinai Medical Center, and Hackensack University Medical Center.
Read the detailed description
The use of bone marrow and stem cell transplantation (BMT/SCT) in the treatment of cancer has increased five-fold over the last decade. Among the cancers treated with BMT/SCT are Hodgkin's Lymphoma, non-Hodgkin's Lymphoma, multiple myeloma, and leukemias such as acute lymphoblastic (ALL), acute myelogenous (AML), chronic lymphocytic (CLL), and chronic myelogenous (CML). With the development of non-myeloablative transplants (either "mini" or reduced intensity transplants) for patients unable to tolerate standard BMT/SCT, the use of this procedure is expected to increase substantially over the next five years. BMT/SCT adversely affects almost every aspect of the patient's life (1;2). A standard (fully ablative) transplant involves conditioning with dose intensive chemotherapy, with or without total body irradiation.
Although various medical regimens and supportive psychosocial services are used to reduce the intensity of these side effects, symptoms may persist. Moreover, the drugs used to control side effects often have aversive side effects of their own. Thus, patients must tolerate a protracted course of treatment that is highly aversive and invasive at a time when their lives are disrupted and they are fearful about their survival. A common complaint among survivors is that such problems go unaddressed, and these types of adjustment problems appear to become most intense in the first year post treatment, when physical functioning has stabilized and contact with the BMT/SCT clinical care team wanes (5;10).
- Conditions
- Hodgkin's Disease, Leukemia, Multiple Myeloma, Non-Hodgkin's Lymphoma
- Being tested
- Cognitive Behavioral Therapy: Questionnaires, Usual Care: Questionnaires
- Keywords
- Survivor, Behavioral Intervention, Bone Marrow, Stem Cell Transplantation
- Medical subject headings
- Hodgkin Disease, Leukemia, Multiple Myeloma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy: QuestionnairesBehavioural
CBT, we will interview you again after you have completed the 10 sessions. We call these follow-up interviews, and they include several phone calls and a questionnaire you would be asked to complete and then mail in. Each follow-up interview will take between 60 and 210 minutes. If you wish, these follow-up interviews can be done over different days. We will do the follow-up interviews three times; at approximately 4 months, 7 months, and 10 months after you complete the baseline interview.
Usual Care: QuestionnairesBehavioural
If you receive Usual Care, you will not receive CBT while you are in the study. You will complete the questionnaires at the same time as participants who receive CBT. If you receive Usual Care you will be offered 10 sessions of CBT at no charge at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 Cognitive-behavioral therapy (CBT) | Cognitive-behavioral therapy (CBT) involves one-on-one counseling Receives: Behavioral: Cognitive Behavioral Therapy: Questionnaires | |
| 2 Usual Care | Usual Care Receives: Behavioral: Usual Care: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the efficacy of a ten-session cognitive-behavioral intervention (CBT-BMT/SCT) on cancer-specific anxiety, psychological distress, and quality of life concerns among BMT/SCT survivors.
Measured: conclusion of study
Secondary outcomes (1)
Explore the influence of patient and medical factors on the impact of CBT-BMT/SCT.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJan 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Derald H. Ruttenberg Cancer Center, Icahn School of Medicine at Mount Sinai, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579917
- Sponsor's protocol ID
- 04-139
- Acronym
- BMT/SCT
- Status last verified
- Jan 2009
- First submitted
- 19 Dec 2007
- Last updated
- 7 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward
- ClinicalTrials.gov ID
- NCT00579917
- Acronym / sponsor ID
- BMT/SCT / 04-139
- Conditions
- Hodgkin's Disease, Leukemia, Multiple Myeloma, Non-Hodgkin's Lymphoma
- Keywords
- Survivor, Behavioral Intervention, Bone Marrow, Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Derald H. Ruttenberg Cancer Center, Icahn School of Medicine at Mount Sinai, Hackensack Meridian Health
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Dec 2007 (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.
The purpose of this study is to understand how to help survivors of bone marrow transplant and stem cell transplant (BMT/SCT) with emotional distress. BMT/SCT has become a more common type of treatment for cancer or hematological disorder (blood disease). For this reason, there is concern that adjustment after treatment may be difficult for many persons. We have found that about 25% of BMT/SCT survivors still feel anxious and distressed about their illness and its treatment after at least one year following transplant. This study is one of the first to study the impact of counseling on BMT/SCT survivors. The study is being carried out at Memorial Sloan-Kettering Cancer Center, Mount Sinai Medical Center, and Hackensack University Medical Center.
Detailed description
The use of bone marrow and stem cell transplantation (BMT/SCT) in the treatment of cancer has increased five-fold over the last decade. Among the cancers treated with BMT/SCT are Hodgkin's Lymphoma, non-Hodgkin's Lymphoma, multiple myeloma, and leukemias such as acute lymphoblastic (ALL), acute myelogenous (AML), chronic lymphocytic (CLL), and chronic myelogenous (CML). With the development of non-myeloablative transplants (either "mini" or reduced intensity transplants) for patients unable to tolerate standard BMT/SCT, the use of this procedure is expected to increase substantially over the next five years. BMT/SCT adversely affects almost every aspect of the patient's life (1;2). A standard (fully ablative) transplant involves conditioning with dose intensive chemotherapy, with or without total body irradiation.
Although various medical regimens and supportive psychosocial services are used to reduce the intensity of these side effects, symptoms may persist. Moreover, the drugs used to control side effects often have aversive side effects of their own. Thus, patients must tolerate a protracted course of treatment that is highly aversive and invasive at a time when their lives are disrupted and they are fearful about their survival. A common complaint among survivors is that such problems go unaddressed, and these types of adjustment problems appear to become most intense in the first year post treatment, when physical functioning has stabilized and contact with the BMT/SCT clinical care team wanes (5;10).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Cognitive-behavioral therapy (CBT) | – | Behavioral: Cognitive Behavioral Therapy: QuestionnairesCognitive-behavioral therapy (CBT) involves one-on-one counseling |
| 2 Usual Care | – | Behavioral: Usual Care: QuestionnairesUsual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics
Key inclusion criteria (7 listed)
- Have significant psychological distress measured by either:
- Do not have a substance abuse disorder
- Do not have cognitive impairment as indicated by a score of 3 or lower on the Mini-Mental Status Exam
- Absence of psychotic symptomatology
- Do not have active suicidal ideation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive Behavioral Therapy: QuestionnairesCBT, we will interview you again after you have completed the 10 sessions. We call these follow-up interviews, and they include several phone calls and a questionnaire you would be asked to complete and then mail in. Each follow-up interview will take between 60 and 210 minutes. If you wish, these follow-up interviews can be done over different days. We will do the follow-up interviews three times; at approximately 4 months, 7 months, and 10 months after you complete the baseline interview. | Behavioural | 1 Cognitive-behavioral therapy (CBT) |
| Usual Care: QuestionnairesIf you receive Usual Care, you will not receive CBT while you are in the study. You will complete the questionnaires at the same time as participants who receive CBT. If you receive Usual Care you will be offered 10 sessions of CBT at no charge at the end of the study. | Behavioural | 2 Usual Care |
Primary outcome
Test the efficacy of a ten-session cognitive-behavioral intervention (CBT-BMT/SCT) on cancer-specific anxiety, psychological distress, and quality of life concerns among BMT/SCT survivors.
Time frame: conclusion of study
1 secondary outcome
Explore the influence of patient and medical factors on the impact of CBT-BMT/SCT.
Time frame: conclusion of study
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 7 Jan 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hodgkin's Disease and Leukemia, run by Memorial Sloan Kettering 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 7 inclusion and 0 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 7 Jan 2009. 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?
Test the efficacy of a ten-session cognitive-behavioral intervention (CBT-BMT/SCT) on cancer-specific anxiety, psychological distress, and quality of life concerns among BMT/SCT survivors. (time frame: conclusion of study). 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 7 Jan 2009.