Anxiety DisorderNCT00014482
Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
A study testing pain therapy and psychosocial assessment and care in people with Anxiety Disorder and Chronic Myeloproliferative Disorders, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Music therapy may be effective in relieving pain and emotional distress in patients who are undergoing cancer therapy. PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and emotional distress in patients with hematologic cancer who are undergoing high-dose therapy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder, Chronic Myeloproliferative Disorders, Depression
- What is being tested?
- pain therapy and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Mar 2003
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of a hematologic malignancy
- No leukemia
- Planned high-dose therapy and autologous stem cell transplantation (HDT/ASCT) at Memorial Sloan-Kettering Cancer Center
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior HDT/ASCT
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial
RATIONALE: Music therapy may be effective in relieving pain and emotional distress in patients who are undergoing cancer therapy.
PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and emotional distress in patients with hematologic cancer who are undergoing high-dose therapy and stem cell transplantation.
Read the detailed description
OBJECTIVES:
- Compare the effects of music therapy vs no music therapy on depression and anxiety in patients with hematologic malignancies undergoing high-dose therapy and autologous stem cell transplantation.
- Compare the effects of these regimens on mood, mucositis pain, pain interference, need for analgesic medication, and length of hospital stay of these patients.
- Compare the immediate effects of these regimens on mood in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to whole body or whole lymphatic irradiation (yes vs no) and diagnosis (non-Hodgkin's lymphoma vs Hodgkin's lymphoma vs myeloma/amyloidosis). Patients are randomized to one of two arms.
- Arm I: Patients receive individualized music therapy over 20-30 minutes beginning on day 0 and continuing over 16 days for a maximum of 12 sessions during high-dose therapy and autologous stem cell transplantation.
Patients complete a Profile of Mood States (POMS) quality of life and pain questionnaire on days -2, 0, 1, 4, 7, 10, 13, and 16.
- Arm II: Patients receive standard psychosocial support during high-dose therapy and autologous stem cell transplantation. Patients complete POMS and mucositis pain questionnaires as in arm I.
PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study.
- Conditions
- Anxiety Disorder, Chronic Myeloproliferative Disorders, Depression, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Being tested
- pain therapy, psychosocial assessment and care
- Keywords
- anxiety disorder, depression, pain, recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, primary myelofibrosis, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV grade 1 follicular lymphoma
- Medical subject headings
- Anxiety Disorders, Myeloproliferative Disorders, Depression, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain therapyProcedure or surgery
psychosocial assessment and careProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2000
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Barrie R. Cassileth, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014482
- Sponsor's protocol ID
- 00-134
- Other IDs
- CDR0000068547, NCI-G01-1934
- Status last verified
- Jun 2013
- First submitted
- 10 Apr 2001
- Last updated
- 18 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00014482
- Acronym / sponsor ID
- 00-134
- Conditions
- Anxiety Disorder, Chronic Myeloproliferative Disorders, Depression, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Keywords
- anxiety disorder, depression, pain, recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2000
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 27 Jan 2003 (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: Music therapy may be effective in relieving pain and emotional distress in patients who are undergoing cancer therapy.
PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and emotional distress in patients with hematologic cancer who are undergoing high-dose therapy and stem cell transplantation.
Detailed description
OBJECTIVES:
- Compare the effects of music therapy vs no music therapy on depression and anxiety in patients with hematologic malignancies undergoing high-dose therapy and autologous stem cell transplantation.
- Compare the effects of these regimens on mood, mucositis pain, pain interference, need for analgesic medication, and length of hospital stay of these patients.
- Compare the immediate effects of these regimens on mood in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to whole body or whole lymphatic irradiation (yes vs no) and diagnosis (non-Hodgkin's lymphoma vs Hodgkin's lymphoma vs myeloma/amyloidosis). Patients are randomized to one of two arms.
- Arm I: Patients receive individualized music therapy over 20-30 minutes beginning on day 0 and continuing over 16 days for a maximum of 12 sessions during high-dose therapy and autologous stem cell transplantation.
Patients complete a Profile of Mood States (POMS) quality of life and pain questionnaire on days -2, 0, 1, 4, 7, 10, 13, and 16.
- Arm II: Patients receive standard psychosocial support during high-dose therapy and autologous stem cell transplantation. Patients complete POMS and mucositis pain questionnaires as in arm I.
PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| pain therapy | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 Jun 2013.
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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.
Barrie R. Cassileth, PhD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain therapy and psychosocial assessment and care in people with Anxiety Disorder and Chronic Myeloproliferative Disorders, 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?
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 18 Jun 2013. 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.
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 18 Jun 2013.