Clinical trial NCT03125070: Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-24
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Cancer and Treatment Distress (CTXD)
timeFrame: Up to 12 months
measure: Health Care Adherence (HCA)-Cardiometabolic
timeFrame: Up to 12 months
measure: Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
timeFrame: 6-weeks after enrollment.
Secondary outcomes:
measure: Health Care Adherence (HCA)-Subsequent Malignancy Screening
timeFrame: Up to 12 months
measure: PHQ-8 Depression
timeFrame: Up to 12 months
Other outcomes:
measure: Knowledge of Survivorship Needs and Health Related Self-efficacy
timeFrame: Up to 12 months
measure: Reach, Engagement and Fidelity of Web-based Intervention
timeFrame: Up to 12 months
measure: Cost and Resources to Maintain Program
timeFrame: 12 months
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: National Marrow Donor Program
state: Minnesota
city: Minneapolis
country: United States
facility: Center for International Blood and Marrow Transplant Research
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Oncology at Baylor Charles A Sammons Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: K. Scott Baker
role: PRINCIPAL_INVESTIGATOR
References: