Hematopoietic and Lymphoid Cell NeoplasmPhase 3INSPIRENCT03125070
Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant
A Phase 3 study testing Best Practice and Internet site with links to existing resources, Internet, Mobile app and Telehealth Intervention and Survey Administration in people with Hematopoietic and Lymphoid Cell Neoplasm, run by Fred Hutchinson Cancer Center at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Best Practice and Internet site with links to existing resources, Internet, Mobile app and Telehealth Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Oct 2020to 31 Dec 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Texas Oncology at Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Loyola University Medical Center
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
National Marrow Donor Program
Minneapolis, Minnesota, 55401
Center for International Blood and Marrow Transplant Research
Minneapolis, Minnesota, 55413-5000
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
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
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.
Read the 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.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Best Practice and Internet site with links to existing resources, Internet, Mobile app and Telehealth Intervention, Survey Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice and Internet site with links to existing resourcesOther
Also called best practice, standard of care, standard therapy
Receive usual care
Internet, Mobile app and Telehealth InterventionOther
Also called Digital Intervention
Receive INSPIRE and survivorship care plan
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (INSPIRE, survivorship care plan) | Experimental | Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan. Receives: Other: Internet, Mobile app and Telehealth Intervention; Other: Survey Administration |
| Group II (usual care) | Active comparator | 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. Receives: Other: Best Practice and Internet site with links to existing resources; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer and Treatment Distress (CTXD)
Among those impaired at baseline, percent who are no longer impaired at 12 months (among those not missing either). Scores range from 0-3 and higher scores indicate higher distress. A cutoff of >=.90 was used to categorize participants as high in distress. Participants with scores <.90 were categorized as not distressed.
Measured: Up to 12 months
Health Care Adherence (HCA)-Cardiometabolic
Assesses adherence to cardiometabolic surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. Scores range from 0-1. Higher scores indicate high adherence. A cutoff of <.80 was used to categorize participants as low in adherence. Scores higher than .80 were classified as being adherent to cardiometabolic surveillance.
Measured: Up to 12 months
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Determine characteristics of participants who 1) do not meet criteria for adequate knowledge of cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program.
Measured: 6-weeks after enrollment.
Secondary outcomes (2)
Health Care Adherence (HCA)-Subsequent Malignancy Screening
Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months.
Measured: Up to 12 months
PHQ-8 Depression
Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start29 Oct 2020
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, K. Scott Baker, Fred Hutchinson Cancer Center
- Investigators
- K. Scott Baker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125070
- Sponsor's protocol ID
- 9819
- Other IDs
- NCI-2017-00583, 9819, R01CA215134, RG1001537
- Acronym
- INSPIRE
- Status last verified
- Jan 2025
- First submitted
- 19 Apr 2017
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No