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MT2018-36 INSPIRE: A Multicenter Randomized Controlled Trial integrating health informatics in a scalable stepped care self-management program for survivors after hematopoietic cell transplantation

Recruiting

This study proposes that predictable health surveillance and unmet emotional needs of adult hematopoietic cell transplantation (HCT) survivors can be improved through a centralized, cost and resource-sparing, national program that optimizes health informatics and provides online expertise and telehealth selfmanagement stepped care when necessary. If successful, this project would provide long-term HCT survivors and their providers with a patient-centered program to facilitate managing their emotional and health care needs. Long-term HCT survivors do not receive adequate care for their unique health and emotional needs due to lack of knowledge and resources to manage these needs in their home communities, although many of these needs have been well defined. Lack of access to care increases premature morbidity and mortality in HCT survivors particularly for cardiovascular and metabolic disease (cardiometabolic) and subsequent malignancies.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
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)

Other: Best Practice and Internet site with links to existing resources, Other: Internet, Mobile app and Telehealth Intervention, Other: Survey Administration

Hematopoietic and Lymphoid Cell Neoplasm

Clinics and Surgery Center (CSC)

Shernan Holtan - sgholtan@umn.edu
Shernan Holtan
Phase 3
STUDY00005572
NCT03125070
See this study on ClinicalTrials.gov

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