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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03125070
- Acronym / sponsor ID
- INSPIRE / 9819
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (INSPIRE, survivorship care plan) | Experimental | Other: Internet, Mobile app and Telehealth Intervention, Other: Survey AdministrationPatients receive immediate access to the INSPIRE online program and personalized survivorship care plan. |
| Group II (usual care) | Active comparator | Other: Best Practice and Internet site with links to existing resources, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Practice and Internet site with links to existing resourcesAlso: best practice, standard of care, standard therapyReceive usual care | Other | Group II (usual care) |
| Internet, Mobile app and Telehealth InterventionAlso: Digital InterventionReceive INSPIRE and survivorship care plan | Other | Group I (INSPIRE, survivorship care plan) |
| Survey AdministrationAncillary studies | Other | Group I (INSPIRE, survivorship care plan), Group II (usual care) |
Primary outcome
Cancer and Treatment Distress (CTXD)
Time frame: Up to 12 months
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.
Health Care Adherence (HCA)-Cardiometabolic
Time frame: Up to 12 months
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.
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks
Time frame: 6-weeks after enrollment.
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.
2 secondary outcomes
Health Care Adherence (HCA)-Subsequent Malignancy Screening
Time frame: Up to 12 months
PHQ-8 Depression
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hematopoietic and Lymphoid Cell Neoplasm
Not yet recruiting
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
Hematologic Cancer
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingPhase 1
Prophylactic DLI-X for Leukemia Relapse After HCT
Acute Lymphoid Leukemia, Acute Myeloid Leukemia
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K. Scott Baker principal investigator
Fred Hutch/University of Washington Cancer Consortium
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer and Treatment Distress (CTXD) (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.