Status:
COMPLETED
Internet-Based Program With or Without Telephone-Based Problem-Solving Training in Helping Long-Term Survivors of Hematopoietic Stem Cell Transplant Cope With Late Complications
Lead Sponsor:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
OBJECTIVES: I. To determine the efficacy of a randomized controlled trial to improve long term fatigue/physical dysfunction, depression/distress and health surveillance behaviors in adult 3 to 25-yea...
Eligibility Criteria
Inclusion
- Hematopoietic stem cell transplant recipient between 3-25 years since last transplant
- Hematopoietic stem cell transplant recipient \> = 2 years since last transplant (second, phase III/IV study only)
- Any type of transplant (autologous, allogeneic, myeloablative, non-myeloablative, marrow or peripheral blood stem cells)
- 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 outcomes (PRO) assessments in English
- Has internet and email access (indicated by logon to site for consent and assessment)
Exclusion
- Does not complete the baseline assessment through the HADS (Hospital Anxiety and Depression Scale)
- Does not complete required assessments in the background and medical history forms required to determine whether meet inclusion and exclusion criteria, stratification, sample description, or primary outcomes (includes age, gender, ethnicity, race, transplant site, and medical information about transplant if not FHCRC or SCCA patient, education, work, height and weight, current medications
- Survivors who score 3.0 or above on the SCL depression measure (indicating severe depression) or who report moderate to severe suicidal ideation will be ineligible for randomization; these survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments
- Survivors who report to us that they have been in active treatment for relapse of their original disease, or for a second cancer, in the past 2 years will be ineligible for randomization, unless the second cancer was treated only with surgical removal (e.g., basal, squamous or localized melanoma skin cancer, or breast ductal carcinoma in situ \[DCIS\])
- These survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1337 Patients enrolled
Trial Details
Trial ID
NCT00799461
Start Date
August 1 2008
Last Update
March 7 2012
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109