Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00799461
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2008-11-26
Brief Title:
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
Sponsor:
Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
INSPIRE An Internet-based RCT for Long-term Survivors of Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 hematopoietic stem cell transplant cope with late complications
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
Detailed Description:
OBJECTIVES
I To determine the efficacy of a randomized controlled trial to improve long term fatiguephysical dysfunction depressiondistress 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 IIIIV 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 IIIIV
OUTLINE Patients with elevated fatigue depression andor 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
I To determine the efficacy of a randomized controlled trial to improve long term fatiguephysical dysfunction depressiondistress 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 IIIIV 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 IIIIV
OUTLINE Patients with elevated fatigue depression andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA112631 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchR01CA112631 |
| NCI-2009-01545 | REGISTRY | None | None |