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
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
About this trial
This is an interventional supportive care trial for Accelerated Phase Chronic Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Sham Comparator
Arm I (full website access w/ PST; first study only)
Arm II (full website access without PST)
Arm III (delayed website access)
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.
Patients receive full access to INSPIRE website for 6 months as in arm I.
Patients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months.