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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 5, 2004 |
| Last Updated Date | August 16, 2006 |
| Start Date ICMJE | July 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00082303 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin’s Lymphoma |
| Official Title ICMJE | Music Imagery for Patients in Protected Environments |
| Brief 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. |
| 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 Phase | Phase I, Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Music Imagery |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 60 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00082303 |
| Responsible Party | |
| Study ID Numbers ICMJE | F32 AT001144-01 |
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) |
| Verification Date | August 2006 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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