Clinical Trials Directory

Trials / Completed

CompletedNCT00799461

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

INSPIRE: An Internet-based RCT for Long-term Survivors of Hematopoietic Stem Cell Transplantation

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,337 (actual)
Sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

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-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

Interventions

TypeNameDescription
OTHERinternet-based interventionDelayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
OTHERquestionnaire administrationCompletion of questions in an online format
PROCEDUREpsychosocial assessment and careAssessment and care of psychosocial aspects
PROCEDUREassessment of therapy complicationsEvaluation of complications of treatment
PROCEDUREmanagement of therapy complicationsManaging therapy complications
PROCEDUREfatigue assessment and managementAssessing and managing fatigue
OTHERcounseling interventionCounseling provided via telephone

Timeline

Start date
2008-08-01
Primary completion
2011-11-01
First posted
2008-11-27
Last updated
2012-03-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00799461. Inclusion in this directory is not an endorsement.