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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:May 15, 2017
End Date:September 15, 2021

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INSPIRE: A Multicenter Randomized Controlled Trial Integrating Health Informatics in a Scalable Stepped Care Self-Management Program for Survivors After Hematopoietic Cell Transplantation

This randomized clinical trial studies health informatics and a self-management program in
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 as a transplant
survivor. A self-management program called "INSPIRE," along with a personalized survivorship
care plan may improve stress and health care for transplant survivors.

PRIMARY OBJECTIVES:

I. Determine whether 2-5 year hematopoietic cell transplant (HCT) survivors with elevated
cancer-related distress or poor health care adherence, adherence to cardiometabolic or
subsequent malignancy surveillance who are randomized to receive the online,
patient-centered, self-management stepped care program will report reduced distress, and
improved health care adherence for cardiometabolic or subsequent malignancy surveillance at
12 months when compared with an active control group who receive access to HCT survivorship
best practices.

II. Determine characteristics of intervention participants who require telehealth stepped
care at 6-week, because they 1) do not meet criteria for adequate knowledge of subsequent
malignancy and cardiometabolic risks, or 2) do not report improved distress, or 3) have not
logged in to the online program.

III. Determine resources that would be needed to sustain the intervention as a national HCT
survivorship program if implemented through the Center for International Blood and Marrow
Transplant Research (CIBMTR)/National Marrow Donor Program (NMDP).

SECONDARY OBJECTIVES:

I. Process measures of internet study reach and utilization, as well as depression, physical
function, physical activity level, and knowledge of survivorship needs in HCT survivors.

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 may receive access to the INSPIRE online
program after 12 months.

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 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)
We found this trial at
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Minneapolis, Minnesota 55413
Principal Investigator: Bronwen E. Shaw
Phone: 414-805-0700
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Theresa Hahn
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Chapel Hill, North Carolina 27599
Principal Investigator: William A Wood Jr
Phone: 919-843-6517
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Charlestown, Massachusetts 02129
Principal Investigator: Areej El-Jawahri
Phone: 617-726-5765
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Navneet S. Majhail
Phone: 216-444-2199
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Dallas, Texas 75246
Principal Investigator: Jana Reynolds
Phone: 214-370-1500
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Joseph P. Uberti
Phone: 313-576-8760
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Kansas City, Kansas 66160
Principal Investigator: Joseph P. McGuirk
Phone: 913-588-5000
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Patrick J. Stiff
Phone: 708-216-8460
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: Bronwen E. Shaw
Phone: 414-805-0700
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Minneapolis, Minnesota 55401
Principal Investigator: Linda J. Burns
Phone: 612-460-4273
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Minneapolis, Minnesota 55455
Principal Investigator: Shernan G. Holtan
Phone: 402-559-6210
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Philadelphia, Pennsylvania 19104
Principal Investigator: Alison W. Loren
Phone: 215-615-3138
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Seattle, Washington 98109
Principal Investigator: Karen L. Syrjala
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Tampa, Florida 33612
Principal Investigator: Heather Jim
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