Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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


Detailed Summary:

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 s
Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Current Primary Outcome:

  • Aggregate number of targeted problems [ Time Frame: At 6 months ]
  • Reach of web-based intervention (second, phase III/IV study only) [ Time Frame: At 6 months ]
    As indicated by proportion logging on the website content for males (targeting 50%), older (targeting 50% over age 55), and geographically underserved participants (targeting 20% rural residents as indicated by zip code), as well as percent who logon to the study website content after initially registering for the study (targeting 90%) second
  • Utilization of web-based intervention (second, phase III/IV study only) [ Time Frame: At 6 months ]
    As indicated by number of pages viewed (targeting a mean of 10), log-on times (targeting a mean of 2) and time from notification of website content access to website content logon (targeting a mean of 2 weeks)
  • Satisfaction, use and barriers ratings at the end of the study including barriers to website use and barriers to using health promotion guidelines (second, phase III/IV study only) [ Time Frame: At 6 months ]
  • Cost to maintain the site content (not including costs for maintenance of the assessment process) (second, phase III/IV study only) [ Time Frame: At 6 months ]
    As indicated by per participant prorated costs for materials and time for updating content, responding to participant comments and requests, maintaining programming and responding to technical problems


Original Primary Outcome: Aggregate number of targeted problems

Current Secondary Outcome:

  • Mean z score combining the Vitality and Physical Function subscales of the SF-36 [ Time Frame: At 6 months ]
  • Mean z score combining the Symptom Checklist 90-R Depression scale and the Cancer and Treatment Distress - Uncertainty subscale [ Time Frame: At 6 months ]
  • Total health care utilization behaviors [ Time Frame: At 6 months ]
  • Long-term fatigue and distress of survivors compared with controls (second, phase III/IV study only) [ Time Frame: At 6 months ]
  • Long-term health promotion of survivors compared with controls (second, phase III/IV study only) [ Time Frame: At 6 months ]


Original Secondary Outcome:

  • Mean z score combining the Vitality and Physical Function subscales of the SF-36
  • Mean z score combining the Symptom Checklist 90-R Depression scale and the Cancer and Treatment Distress-Uncertainty subscale
  • Total health care utilization behaviors


Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: November 26, 2008
Date Started: August 2008
Date Completion:
Last Updated: March 5, 2012
Last Verified: March 2012