Back to resultsSelf-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant (INSPIRE)
Primary Purpose
Hematopoietic and Lymphoid Cell Neoplasm
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Best Practice and Internet site with links to existing resources
Internet, Mobile app and Telehealth Intervention
Survey Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm
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)
Sites / Locations
- Moffitt Cancer Center
- Loyola University Medical Center
- University of Kansas Cancer Center
- Massachusetts General Hospital Cancer Center
- Wayne State University/Karmanos Cancer Institute
- National Marrow Donor Program
- Center for International Blood and Marrow Transplant Research
- University of Minnesota/Masonic Cancer Center
- Roswell Park Cancer Institute
- UNC Lineberger Comprehensive Cancer Center
- Cleveland Clinic Foundation
- University of Pennsylvania/Abramson Cancer Center
- Texas Oncology at Baylor Charles A Sammons Cancer Center
- Fred Hutch/University of Washington Cancer Consortium
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I (INSPIRE, survivorship care plan)
Group II (usual care)
Arm Description
Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
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.
Outcomes
Primary Outcome Measures
Cancer and Treatment Distress (CTXD)
Assesses distress or worry level.
Health Care Adherence (HCA)-cardio
Assesses adherence to cardiometabolic surveillance.
HCA-cancer
Assesses adherence to subsequent malignancy surveillance.
Secondary Outcome Measures
Reach of web-based intervention
Rates of participants approached versus registering.
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.
PHQ-8 Depression
Assessed by patient questionnaire.
PROMIS physical function
Assessed by patient questionnaire.
Knowledge of survivorship needs
Assessed by patient questionnaire.
Full Information
NCT ID
NCT03125070
First Posted
April 19, 2017
Last Updated
June 27, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03125070
Brief Title
Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
548 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (INSPIRE, survivorship care plan)
Arm Type
Experimental
Arm Description
Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Arm Title
Group II (usual care)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice and Internet site with links to existing resources
Other Intervention Name(s)
best practice, standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Other
Intervention Name(s)
Internet, Mobile app and Telehealth Intervention
Other Intervention Name(s)
Digital Intervention
Intervention Description
Receive INSPIRE and survivorship care plan
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Cancer and Treatment Distress (CTXD)
Description
Assesses distress or worry level.
Time Frame
Up to 12 months
Title
Health Care Adherence (HCA)-cardio
Description
Assesses adherence to cardiometabolic surveillance.
Time Frame
Up to 12 months
Title
HCA-cancer
Description
Assesses adherence to subsequent malignancy surveillance.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Reach of web-based intervention
Description
Rates of participants approached versus registering.
Time Frame
Up to 12 months
Title
Utilization of web-based intervention
Description
Assessed by number of visits to the site, number of pages viewed, types of modalities used, attrition rates and support requests.
Time Frame
Up to 12 months
Title
PHQ-8 Depression
Description
Assessed by patient questionnaire.
Time Frame
Up to 12 months
Title
PROMIS physical function
Description
Assessed by patient questionnaire.
Time Frame
Up to 12 months
Title
Knowledge of survivorship needs
Description
Assessed by patient questionnaire.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Scott Baker
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
National Marrow Donor Program
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55401
Country
United States
Facility Name
Center for International Blood and Marrow Transplant Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55413-5000
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Oncology at Baylor Charles A Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant
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