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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00799461 |
RATIONALE: A personalized Internet-based program may help improve fatigue, depression, and quality of life in long-term survivors of stem cell transplant. It is not yet known whether an Internet-based program is more effective with or without telephone-based problem-solving training.
PURPOSE: This randomized clinical trial is studying how well an Internet-based program works with or without telephone-based problem-solving training in helping long-term survivors of stem cell transplant cope with late complications.
Condition | Intervention |
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Cancer |
Other: internet-based intervention Other: questionnaire administration Procedure: assessment of therapy complications Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care |
Study Type: | Interventional |
Study Design: | Randomized, Active Control |
Official Title: | INSPIRE: An Internet-Based RCT for Long-Term Survivors of Hematopoietic Stem Cell Transplantation |
Estimated Enrollment: | 864 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to gender, type of stem cell transplantation (autologous vs allogeneic), ethnicity (non-Caucasian or Hispanic vs Caucasian or non-Hispanic), and transplant location (Fred Hutchinson Center vs non-Fred Hutchinson center). Patients with elevated fatigue, depression, and/or distress on baseline assessment are randomized to 1 of 3 arms. Patients without elevated fatigue, depression, and/or distress on baseline assessment are randomized to 1 of 2 arms (arms II or III).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Has undergone hematopoietic stem cell transplantation 5-20 years ago
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Karen Syrjala, MD 206-667-4579 |
Principal Investigator: | Karen Syrjala, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Karen Syrjala ) |
Study ID Numbers: | CDR0000614627, FHCRC-2258.00, FHCRC-IR-6743 |
Study First Received: | November 26, 2008 |
Last Updated: | August 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00799461 History of Changes |
Health Authority: | Unspecified |
fatigue long-term effects secondary to cancer therapy in adults psychosocial effects of cancer and its treatment depression stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma |
stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma |
Chronic Myelomonocytic Leukemia Blast Crisis Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Mycoses Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Depression |
Immunoproliferative Disorders Testicular Cancer Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Hairy Cell Leukemia Myeloproliferative Disorders Breast Neoplasms Leukemia, Myeloid Testicular Neoplasms Depressive Disorder Multiple Myeloma B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Gestational Trophoblastic Neoplasms Chronic Myelogenous Leukemia |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Large-Cell, Immunoblastic Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |