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Internet-Based Program With or Without Telephone-Based Problem-Solving Training in Helping Long-Term Survivors of Stem Cell Transplant Cope With Late Complications
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2009
First Received: November 26, 2008   Last Updated: August 29, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00799461
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Aggregate number of targeted problems [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean z score combining the Vitality and Physical Function subscales of the SF-36 [ Designated as safety issue: No ]
  • Mean z score combining the Symptom Checklist 90-R Depression scale and the Cancer and Treatment Distress-Uncertainty subscale [ Designated as safety issue: No ]
  • Total health-care utilization behaviors [ Designated as safety issue: No ]

Estimated Enrollment: 864
Study Start Date: August 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To compare the efficacy of an Internet-only intervention vs an Internet intervention with phone-based problem-solving and activation training vs delayed access to Internet intervention in improving fatigue/physical dysfunction, depression/distress, and health surveillance behaviors in long-term survivors of hematopoietic stem cell transplantation.

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).

  • Arm I (full website access with problem-solving training [PST]): Patients receive full access to INSPIRE website for 6 months, which offers an individually tailored greeting home page with links to information on each of the target areas identified as being elevated on baseline assessment and how to manage the complications; a bulletin board with input from other survivors that is solicited, edited, and posted weekly; resource pages; and an opportunity to send secure messages with questions or comments. Patients also undergo 4-8 phone-based PST sessions with a behavioral health specialist.
  • Arm II (full website access without PST): Patients receive full access to INSPIRE website for 6 months as in arm I.
  • Arm III (delayed website access): Patients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months. Patients complete online questionnaires at baseline and at 3 and 6 months to assess fatigue, physical activity, depression, and distress.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Has undergone hematopoietic stem cell transplantation 5-20 years ago

    • Any type of transplant (autologous, allogeneic, myeloablative, non-myeloablative, bone marrow, or peripheral blood stem cells) allowed

PATIENT CHARACTERISTICS:

  • Able to communicate in English as indicated by ability to communicate adequately with study staff to participate in the clinical phone calls and to complete patient-reported outcome assessments in English
  • Has Internet and e-mail access
  • SCL depression measure score < 3.0
  • No moderate to severe suicidal ideation
  • No other malignancy within the past 2 years, except for basal cell or squamous cell skin cancer, localized melanoma, or ductal carcinoma in situ of the breast treated only with surgical resection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 2 years since prior active treatment for relapse of original disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799461

Locations
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Karen Syrjala, MD     206-667-4579        
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Karen Syrjala, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoma, Large-Cell, Immunoblastic
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on September 10, 2009