NCT00799461|CompletedPhase 3

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

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium ClinicalTrials.gov

Compare

3 other identifiers

2258.00NCI-2009-01545R01CA112631

Study Type

interventional

Target

1,337

Locations

1 country

Sites

Timeline

RegisteredNov 2008

StartedAug 2008

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,337

participants targeted

Target at P75+ for phase_3

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed

Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

3.3 years

First QC Date

November 26, 2008

Last Update Submit

March 5, 2012

Conditions

Outcome Measures

Primary Outcomes (5)

Aggregate number of targeted problems
At 6 months
Reach of web-based intervention (second, phase III/IV study only)
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
At 6 months
Utilization of web-based intervention (second, phase III/IV study only)
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)
At 6 months
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)
At 6 months
Cost to maintain the site content (not including costs for maintenance of the assessment process) (second, phase III/IV study only)
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
At 6 months

Secondary Outcomes (5)

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

Study Arms (3)

Arm I (full website access w/ PST; first study only)

EXPERIMENTAL

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.

Other: internet-based interventionOther: questionnaire administrationProcedure: psychosocial assessment and careProcedure: assessment of therapy complicationsProcedure: management of therapy complicationsProcedure: fatigue assessment and managementOther: counseling intervention

Arm II (full website access without PST)

EXPERIMENTAL

Patients receive full access to INSPIRE website for 6 months as in arm I.

Arm III (delayed website access)

SHAM COMPARATOR

Patients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months.

Interventions

internet-based interventionOTHER

Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation