Depression Clinical Trial
Official title:
INSPIRE: An Internet-based RCT for Long-term Survivors of Hematopoietic Stem Cell Transplantation
| Verified date | March 2012 |
| Source | Fred Hutchinson Cancer Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1337 |
| Est. completion date | |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Aggregate number of targeted problems | At 6 months | No | |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No | |
| Primary | 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 | No |
| Secondary | Mean z score combining the Vitality and Physical Function subscales of the SF-36 | At 6 months | No | |
| Secondary | Mean z score combining the Symptom Checklist 90-R Depression scale and the Cancer and Treatment Distress - Uncertainty subscale | At 6 months | No | |
| Secondary | Total health care utilization behaviors | At 6 months | No | |
| Secondary | Long-term fatigue and distress of survivors compared with controls (second, phase III/IV study only) | At 6 months | No | |
| Secondary | Long-term health promotion of survivors compared with controls (second, phase III/IV study only) | At 6 months | No |
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