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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

— INSPIRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125070
• Other study ID #: 9819
• Secondary ID: NCI-2017-0058398
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Other:
• Best Practice and Internet site with links to existing resources
Receive usual care
• Internet, Mobile app and Telehealth Intervention
Receive INSPIRE and survivorship care plan
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Texas Oncology at Baylor Charles A Sammons Cancer Center	Dallas	Texas
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Center for International Blood and Marrow Transplant Research	Minneapolis	Minnesota
United States	National Marrow Donor Program	Minneapolis	Minnesota
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer and Treatment Distress (CTXD)	Assesses distress or worry level.	Up to 12 months
Primary	Health Care Adherence (HCA)-cardio	Assesses adherence to cardiometabolic surveillance.	Up to 12 months
Primary	HCA-cancer	Assesses adherence to subsequent malignancy surveillance.	Up to 12 months
Secondary	Reach of web-based intervention	Rates of participants approached versus registering.	Up to 12 months
Secondary	Utilization of web-based intervention	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
Secondary	PHQ-8 Depression	Assessed by patient questionnaire.	Up to 12 months
Secondary	PROMIS physical function	Assessed by patient questionnaire.	Up to 12 months
Secondary	Knowledge of survivorship needs	Assessed by patient questionnaire.	Up to 12 months