LeukemiaPhase 1/2NCT00082303
Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma
A Phase 1/2 study testing Music Imagery in people with Leukemia and Lymphoma, Non-Hodgkin, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leukemia, Lymphoma, Non-Hodgkin
- What is being tested?
- Music Imagery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to not given
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Indiana University Hematologic Malignancy Program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-Hodgkin's lymphoma
- Able to read and understand English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center/University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Music Imagery for Patients in Protected Environments
The purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma.
Read the detailed description
Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. Patients treated in isolation units may experience elevated levels of psychological distress. Both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on these patients.
Participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. Participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. All participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue.
- Conditions
- Leukemia, Lymphoma, Non-Hodgkin
- Being tested
- Music Imagery
- Keywords
- Music Therapy, Anxiety, Depression
- Medical subject headings
- Leukemia, Lymphoma, Non-Hodgkin, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ImageryBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2004 (estimated)
- Study startJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082303
- Sponsor's protocol ID
- F32AT001144-01
- Status last verified
- Aug 2006
- First submitted
- 5 May 2004
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Imagery for Patients in Protected Environments
- ClinicalTrials.gov ID
- NCT00082303
- Acronym / sponsor ID
- F32AT001144-01
- Conditions
- Leukemia, Lymphoma, Non-Hodgkin
- Keywords
- Music Therapy, Anxiety, Depression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jul 2002
- First posted
- 6 May 2004 (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 explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma.
Detailed description
Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. Patients treated in isolation units may experience elevated levels of psychological distress. Both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on these patients.
Participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. Participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. All participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to Indiana University Hematologic Malignancy Program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-Hodgkin's lymphoma
- Able to read and understand English
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 |
|---|---|---|
| Music Imagery | Behavioural | – |
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 Aug 2006.
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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?
A Phase 1/2 study testing Music Imagery in people with Leukemia and Lymphoma, Non-Hodgkin, run by National Center for Complementary and Integrative Health (NCCIH) 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 2 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 18 Aug 2006. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Aug 2006.