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
NCT ID: NCT00799461
Last Updated: 2012-03-07
Study Results
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Basic Information
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COMPLETED
PHASE3
1337 participants
INTERVENTIONAL
2008-08-31
Brief Summary
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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 hematopoietic stem cell transplant cope with late complications
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Detailed Description
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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-year hematopoietic stem cell transplant (HSCT) survivors using an internet only or internet and phone-based problem-solving and activation training compared with survivors randomized to a delayed internet access control.
II. To determine the reach, utilization, and implementation costs of a web-based, individually tailored intervention, disseminated through widely used patient information websites, targeting a national cohort of adult 2-25 year HSCT survivors. (Phase III/IV) III. To determine, in a randomized controlled trial, the efficacy of a nationally disseminated, internet-based, individually tailored intervention to improve long-term fatigue, distress and health promotion behaviors in HSCT survivors, compared with survivors randomized to a delayed internet access control. (Phase III/IV)
OUTLINE: Patients with elevated fatigue, depression, and/or distress at baseline are randomized to 1 of 3 arms (ARMS I, II, or III). Patients without elevated fatigue, depression or distress at baseline are randomized to 1 of 2 arms (ARMS II or III).
ARM I (FULL WEBSITE ACCESS WITH PROBLEM-SOLVING TRAINING \[PST\]; FIRST STUDY ONLY; CLOSED TO ACCRUAL): 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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (full website access w/ PST; first study only)
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.
internet-based intervention
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
questionnaire administration
Completion of questions in an online format
psychosocial assessment and care
Assessment and care of psychosocial aspects
assessment of therapy complications
Evaluation of complications of treatment
management of therapy complications
Managing therapy complications
fatigue assessment and management
Assessing and managing fatigue
counseling intervention
Counseling provided via telephone
Arm II (full website access without PST)
Patients receive full access to INSPIRE website for 6 months as in arm I.
internet-based intervention
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
questionnaire administration
Completion of questions in an online format
psychosocial assessment and care
Assessment and care of psychosocial aspects
assessment of therapy complications
Evaluation of complications of treatment
management of therapy complications
Managing therapy complications
fatigue assessment and management
Assessing and managing fatigue
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.
internet-based intervention
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
questionnaire administration
Completion of questions in an online format
psychosocial assessment and care
Assessment and care of psychosocial aspects
assessment of therapy complications
Evaluation of complications of treatment
management of therapy complications
Managing therapy complications
fatigue assessment and management
Assessing and managing fatigue
Interventions
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internet-based intervention
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
questionnaire administration
Completion of questions in an online format
psychosocial assessment and care
Assessment and care of psychosocial aspects
assessment of therapy complications
Evaluation of complications of treatment
management of therapy complications
Managing therapy complications
fatigue assessment and management
Assessing and managing fatigue
counseling intervention
Counseling provided via telephone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Principal Investigators
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Karen Syrjala
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Walsh CA, Yi JC, Leisenring WM, Syrjala KL. Social Support, Coping, and Cancer-Related Health Burden in Long-term Survivors Treated with Hematopoietic Stem Cell Transplantation as Adolescents or Young Adults. J Adolesc Young Adult Oncol. 2023 Aug;12(4):496-502. doi: 10.1089/jayao.2022.0105. Epub 2022 Oct 25.
Norskov KH, Yi JC, Crouch ML, Fiscalini AS, Flowers MED, Syrjala KL. Social support as a moderator of healthcare adherence and distress in long-term hematopoietic cell transplantation survivors. J Cancer Surviv. 2021 Dec;15(6):866-875. doi: 10.1007/s11764-020-00979-4. Epub 2021 Jan 9.
Walsh CA, Yi JC, Rosenberg AR, Crouch MV, Leisenring WM, Syrjala KL. Factors associated with social functioning among long-term cancer survivors treated with hematopoietic stem cell transplantation as adolescents or young adults. Psychooncology. 2020 Oct;29(10):1579-1586. doi: 10.1002/pon.5460. Epub 2020 Aug 13.
Other Identifiers
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NCI-2009-01545
Identifier Type: REGISTRY
Identifier Source: secondary_id
2258.00
Identifier Type: -
Identifier Source: org_study_id
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