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

• Aggregate number of targeted problems [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  
• Reach of web-based intervention (second, phase III/IV study only) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  
• 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 ] [ Designated as safety issue: No ]
  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
  
  

• Mean z score combining the Vitality and Physical Function subscales of the SF-36 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  
• Mean z score combining the Symptom Checklist 90-R Depression scale and the Cancer and Treatment Distress - Uncertainty subscale [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  
• Total health care utilization behaviors [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  
• Long-term fatigue and distress of survivors compared with controls (second, phase III/IV study only) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  
• Long-term health promotion of survivors compared with controls (second, phase III/IV study only) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  

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.