Depression Clinical Trial
Official title:
INSPIRE: An Internet-based RCT for Long-term Survivors of Hematopoietic Stem Cell Transplantation
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
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.
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Supportive Care
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