- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125070
Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant (INSPIRE)
March 27, 2024 updated by: Fred Hutchinson Cancer Center
INSPIRE: A Multicenter Randomized Controlled Trial Integrating Health Informatics in a Scalable Stepped Care Self-Management Program for Survivors After Hematopoietic Cell Transplantation
This phase III trial investigates health informatics and a self-management program for improving the health of cancer survivors after stem cell transplant.
After transplant many survivors may feel stressed or may be unsure of what health care they need.
A self-management program called "INSPIRE," along with a personalized survivorship care plan may improve stress and health care for transplant survivors.
Study Overview
Status
Completed
Conditions
Detailed Description
OUTLINE:
Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
GROUP II: Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients receive access to the INSPIRE online program after 12 months.
Study Type
Interventional
Enrollment (Actual)
548
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
-
-
Florida
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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Minneapolis, Minnesota, United States, 55401
- National Marrow Donor Program
-
Minneapolis, Minnesota, United States, 55413-5000
- Center for International Blood and Marrow Transplant Research
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania/Abramson Cancer Center
-
-
Texas
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Dallas, Texas, United States, 75246
- Texas Oncology at Baylor Charles A Sammons Cancer Center
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College Of Wisconsin
-
-
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
Description
Inclusion Criteria:
- Received >= 1 autologous or allogeneic (related or unrelated) HCT with curative intent at a participating transplant center for a hematologic malignancy
- Age 18 years of age or older at last transplant
- Survival 2-5 years after last HCT when first approached for enrollment
- In remission at time of study entry, may be receiving chemoprevention
- Internet and email access
- American and Canadian citizens, and/or those with mailing addresses in the United States (US)/Canada and/or temporarily residing anywhere outside the country (IE - military).
Exclusion Criteria:
- Development of invasive subsequent malignancy after HCT other than non-melanoma skin cancer, in the past two years
- Medical or other issue prohibiting computer use, reading or ability to comply with all study procedures or unable to communicate via phone (e.g., significant vision, hearing or cognitive impairment, major illness, hospitalization)
- Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
- Does not complete baseline patient-reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
- Non-proficient in English (written and spoken)
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (INSPIRE, survivorship care plan)
Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
|
Ancillary studies
Receive INSPIRE and survivorship care plan
Other Names:
|
Active Comparator: Group II (usual care)
Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan.
Patients may receive access to the INSPIRE online program after 12 months.
|
Ancillary studies
Receive usual care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer and Treatment Distress (CTXD)
Time Frame: Up to 12 months
|
Assesses distress or worry level.
|
Up to 12 months
|
Health Care Adherence (HCA)-cardio
Time Frame: Up to 12 months
|
Assesses adherence to cardiometabolic surveillance.
|
Up to 12 months
|
HCA-cancer
Time Frame: Up to 12 months
|
Assesses adherence to subsequent malignancy surveillance.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reach of web-based intervention
Time Frame: Up to 12 months
|
Rates of participants approached versus registering.
|
Up to 12 months
|
Utilization of web-based intervention
Time Frame: Up to 12 months
|
Assessed by number of visits to the site, number of pages viewed, types of modalities used, attrition rates and support requests.
|
Up to 12 months
|
PHQ-8 Depression
Time Frame: Up to 12 months
|
Assessed by patient questionnaire.
|
Up to 12 months
|
PROMIS physical function
Time Frame: Up to 12 months
|
Assessed by patient questionnaire.
|
Up to 12 months
|
Knowledge of survivorship needs
Time Frame: Up to 12 months
|
Assessed by patient questionnaire.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: K. Scott Baker, Fred Hutch/University of Washington Cancer Consortium
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 (Actual)
October 29, 2020
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
April 19, 2017
First Submitted That Met QC Criteria
April 19, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9819 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2017-00583 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA215134 (U.S. NIH Grant/Contract)
- RG1001537 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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