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

March 5, 2012 updated by: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1337

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hematopoietic stem cell transplant recipient between 3-25 years since last transplant
  • Hematopoietic stem cell transplant recipient > = 2 years since last transplant (second, phase III/IV study only)
  • Any type of transplant (autologous, allogeneic, myeloablative, non-myeloablative, marrow or peripheral blood stem cells)
  • Able to communicate in English as indicated by ability to communicate adequately with study staff to participate in the clinical phone calls and to complete patient-reported outcomes (PRO) assessments in English
  • Has internet and email access (indicated by logon to site for consent and assessment)

Exclusion Criteria:

  • Does not complete the baseline assessment through the HADS (Hospital Anxiety and Depression Scale)
  • Does not complete required assessments in the background and medical history forms required to determine whether meet inclusion and exclusion criteria, stratification, sample description, or primary outcomes (includes age, gender, ethnicity, race, transplant site, and medical information about transplant if not FHCRC or SCCA patient, education, work, height and weight, current medications
  • Survivors who score 3.0 or above on the SCL depression measure (indicating severe depression) or who report moderate to severe suicidal ideation will be ineligible for randomization; these survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments
  • Survivors who report to us that they have been in active treatment for relapse of their original disease, or for a second cancer, in the past 2 years will be ineligible for randomization, unless the second cancer was treated only with surgical removal (e.g., basal, squamous or localized melanoma skin cancer, or breast ductal carcinoma in situ [DCIS])
  • These survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (full website access w/ PST; first study only)
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 intervention
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
Other: questionnaire administration
Completion of questions in an online format
Procedure: psychosocial assessment and care
Assessment and care of psychosocial aspects
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
Procedure: assessment of therapy complications
Evaluation of complications of treatment
Procedure: management of therapy complications
Managing therapy complications
Other Names:
  • complications of therapy, management of
Procedure: fatigue assessment and management
Assessing and managing fatigue
Other Names:
  • fatigue assessment/management
Other: counseling intervention
Counseling provided via telephone
Other Names:
  • counseling and communications studies
Experimental: Arm II (full website access without PST)
Patients receive full access to INSPIRE website for 6 months as in arm I.
Other: internet-based intervention
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
Other: questionnaire administration
Completion of questions in an online format
Procedure: psychosocial assessment and care
Assessment and care of psychosocial aspects
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
Procedure: assessment of therapy complications
Evaluation of complications of treatment
Procedure: management of therapy complications
Managing therapy complications
Other Names:
  • complications of therapy, management of
Procedure: fatigue assessment and management
Assessing and managing fatigue
Other Names:
  • fatigue assessment/management
Sham Comparator: 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.
Other: internet-based intervention
Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation
Other: questionnaire administration
Completion of questions in an online format
Procedure: psychosocial assessment and care
Assessment and care of psychosocial aspects
Other Names:
  • psychosocial assessment
  • psychosocial assessment/care
  • psychosocial care
  • psychosocial care/assessment
  • psychosocial studies
Procedure: assessment of therapy complications
Evaluation of complications of treatment
Procedure: management of therapy complications
Managing therapy complications
Other Names:
  • complications of therapy, management of
Procedure: fatigue assessment and management
Assessing and managing fatigue
Other Names:
  • fatigue assessment/management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aggregate number of targeted problems
Time Frame: At 6 months
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
At 6 months
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)
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)
Time Frame: At 6 months
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
At 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean z score combining the Vitality and Physical Function subscales of the SF-36
Time Frame: At 6 months
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
At 6 months
Total health care utilization behaviors
Time Frame: At 6 months
At 6 months
Long-term fatigue and distress of survivors compared with controls (second, phase III/IV study only)
Time Frame: At 6 months
At 6 months
Long-term health promotion of survivors compared with controls (second, phase III/IV study only)
Time Frame: At 6 months
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen Syrjala, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (Estimate)

November 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2258.00
  • NCI-2009-01545 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA112631 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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