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Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant (INSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125070
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : June 6, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Other: Best Practice and Internet site with links to existing resources Other: Internet, Mobile app and Telehealth Intervention Other: Survey Administration Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: INSPIRE: A Multicenter Randomized Controlled Trial Integrating Health Informatics in a Scalable Stepped Care Self-Management Program for Survivors After Hematopoietic Cell Transplantation
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Group I (INSPIRE, survivorship care plan)
Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Other: Internet, Mobile app and Telehealth Intervention
Receive INSPIRE and survivorship care plan
Other Name: Digital Intervention

Other: Survey Administration
Ancillary studies

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.
Other: Best Practice and Internet site with links to existing resources
Receive usual care
Other Names:
  • best practice
  • standard of care
  • standard therapy

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Cancer and Treatment Distress (CTXD) [ Time Frame: Up to 12 months ]
    Assesses distress or worry level.

  2. Health Care Adherence (HCA)-cardio [ Time Frame: Up to 12 months ]
    Assesses adherence to cardiometabolic surveillance.

  3. HCA-cancer [ Time Frame: Up to 12 months ]
    Assesses adherence to subsequent malignancy surveillance.


Secondary Outcome Measures :
  1. Reach of web-based intervention [ Time Frame: Up to 12 months ]
    Rates of participants approached versus registering.

  2. 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.

  3. PHQ-8 Depression [ Time Frame: Up to 12 months ]
    Assessed by patient questionnaire.

  4. PROMIS physical function [ Time Frame: Up to 12 months ]
    Assessed by patient questionnaire.

  5. Knowledge of survivorship needs [ Time Frame: Up to 12 months ]
    Assessed by patient questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125070


Contacts
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Contact: K. Scott Baker 206-667-5594 ksbaker@fredhutch.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Heather Jim    813-745-6369    heather.jim@moffitt.org   
Principal Investigator: Heather Jim         
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Patrick J. Stiff    708-216-8460    pstiff@lumc.edu   
Principal Investigator: Patrick J. Stiff         
United States, Kansas
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Joseph P. McGuirk    913-588-5000    jmcguirk@kumc.edu   
Principal Investigator: Joseph P. McGuirk         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Areej El-Jawahri    617-726-5765    areej_el-jawahri@dfci.harvard.edu   
Principal Investigator: Areej El-Jawahri         
United States, Michigan
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Joseph P. Uberti    313-576-8760    ubertij@karmanos.org   
Principal Investigator: Joseph P. Uberti         
United States, Minnesota
National Marrow Donor Program Not yet recruiting
Minneapolis, Minnesota, United States, 55401
Contact: Jeffery Auletta       jeffauletta@nationwidechildren.org   
Principal Investigator: Jeffery Auletta         
Center for International Blood and Marrow Transplant Research Not yet recruiting
Minneapolis, Minnesota, United States, 55413-5000
Contact: Bronwen E. Shaw    414-805-0700    beshaw@mcw.edu   
Principal Investigator: Bronwen E. Shaw         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Shernan G. Holtan    402-559-6210    sghotlan@umn.edu   
Principal Investigator: Shernan G. Holtan         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Theresa Hahn    877-275-7724    Theresa.hahn@Rosswellpark.org   
Principal Investigator: Theresa Hahn         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: William A Wood Jr    919-843-6517    wawood@email.unc.edu   
Principal Investigator: William A Wood Jr         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Betty Hamilton    216-445-7580      
Principal Investigator: Betty Hamilton         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alison W. Loren    215-615-3138    Alison.Loren@uphs.upenn.edu   
Principal Investigator: Alison W. Loren         
United States, Texas
Texas Oncology at Baylor Charles A Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Jana Reynolds    214-370-1500    jana.reynolds@BSWHealth.org   
Principal Investigator: Jana Reynolds         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: K. Scott Baker    206-667-5594    ksbaker@fredhutch.org   
Principal Investigator: K. Scott Baker         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Bronwen E. Shaw    414-805-0700    beshaw@mcw.edu   
Principal Investigator: Bronwen E. Shaw         
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: K. Scott Baker Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT03125070    
Other Study ID Numbers: 9819
NCI-2017-00583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9819 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
R01CA215134 ( U.S. NIH Grant/Contract )
RG1001537 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases