Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant (INSPIRE)
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| ClinicalTrials.gov Identifier: NCT03125070 |
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Recruitment Status :
Recruiting
First Posted : April 24, 2017
Last Update Posted : June 6, 2022
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Sponsor:
Fred Hutchinson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Other: Best Practice and Internet site with links to existing resources Other: Internet, Mobile app and Telehealth Intervention Other: Survey Administration | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 980 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Supportive Care |
| 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 |
| Actual Study Start Date : | November 5, 2020 |
| Estimated Primary Completion Date : | October 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group I (INSPIRE, survivorship care plan)
Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
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Other: Internet, Mobile app and Telehealth Intervention
Receive INSPIRE and survivorship care plan
Other Name: Digital Intervention Other: Survey Administration Ancillary studies |
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Active Comparator: Group II (usual care)
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.
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Other: Best Practice and Internet site with links to existing resources
Receive usual care
Other Names:
Other: Survey Administration Ancillary studies |
Primary Outcome Measures :
- Cancer and Treatment Distress (CTXD) [ Time Frame: Up to 12 months ]Assesses distress or worry level.
- Health Care Adherence (HCA)-cardio [ Time Frame: Up to 12 months ]Assesses adherence to cardiometabolic surveillance.
- HCA-cancer [ Time Frame: Up to 12 months ]Assesses adherence to subsequent malignancy surveillance.
Secondary Outcome Measures :
- Reach of web-based intervention [ Time Frame: Up to 12 months ]Rates of participants approached versus registering.
- Utilization of web-based intervention [ Time Frame: Up to 12 months ]Assessed by number of visits to the site, number of pages viewed, types of modalities used, attrition rates and support requests.
- PHQ-8 Depression [ Time Frame: Up to 12 months ]Assessed by patient questionnaire.
- PROMIS physical function [ Time Frame: Up to 12 months ]Assessed by patient questionnaire.
- Knowledge of survivorship needs [ Time Frame: Up to 12 months ]Assessed by patient questionnaire.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125070
Contacts
| Contact: K. Scott Baker | 206-667-5594 | ksbaker@fredhutch.org |
Locations
| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Heather Jim 813-745-6369 heather.jim@moffitt.org | |
| Principal Investigator: Heather Jim | |
| United States, Illinois | |
| Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Patrick J. Stiff 708-216-8460 pstiff@lumc.edu | |
| Principal Investigator: Patrick J. Stiff | |
| United States, Kansas | |
| University of Kansas Cancer Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Joseph P. McGuirk 913-588-5000 jmcguirk@kumc.edu | |
| Principal Investigator: Joseph P. McGuirk | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Areej El-Jawahri 617-726-5765 areej_el-jawahri@dfci.harvard.edu | |
| Principal Investigator: Areej El-Jawahri | |
| United States, Michigan | |
| Wayne State University/Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Joseph P. Uberti 313-576-8760 ubertij@karmanos.org | |
| Principal Investigator: Joseph P. Uberti | |
| United States, Minnesota | |
| National Marrow Donor Program | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55401 | |
| Contact: Jeffery Auletta jeffauletta@nationwidechildren.org | |
| Principal Investigator: Jeffery Auletta | |
| Center for International Blood and Marrow Transplant Research | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55413-5000 | |
| Contact: Bronwen E. Shaw 414-805-0700 beshaw@mcw.edu | |
| Principal Investigator: Bronwen E. Shaw | |
| University of Minnesota/Masonic Cancer Center | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Shernan G. Holtan 402-559-6210 sghotlan@umn.edu | |
| Principal Investigator: Shernan G. Holtan | |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Theresa Hahn 877-275-7724 Theresa.hahn@Rosswellpark.org | |
| Principal Investigator: Theresa Hahn | |
| United States, North Carolina | |
| UNC Lineberger Comprehensive Cancer Center | Not yet recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: William A Wood Jr 919-843-6517 wawood@email.unc.edu | |
| Principal Investigator: William A Wood Jr | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Betty Hamilton 216-445-7580 | |
| Principal Investigator: Betty Hamilton | |
| United States, Pennsylvania | |
| University of Pennsylvania/Abramson Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Alison W. Loren 215-615-3138 Alison.Loren@uphs.upenn.edu | |
| Principal Investigator: Alison W. Loren | |
| United States, Texas | |
| Texas Oncology at Baylor Charles A Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Jana Reynolds 214-370-1500 jana.reynolds@BSWHealth.org | |
| Principal Investigator: Jana Reynolds | |
| United States, Washington | |
| Fred Hutch/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: K. Scott Baker 206-667-5594 ksbaker@fredhutch.org | |
| Principal Investigator: K. Scott Baker | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Bronwen E. Shaw 414-805-0700 beshaw@mcw.edu | |
| Principal Investigator: Bronwen E. Shaw | |
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | K. Scott Baker | Fred Hutch/University of Washington Cancer Consortium |
| Responsible Party: | Fred Hutchinson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03125070 |
| Other Study ID Numbers: |
9819 NCI-2017-00583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 9819 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) R01CA215134 ( U.S. NIH Grant/Contract ) RG1001537 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) |
| First Posted: | April 24, 2017 Key Record Dates |
| Last Update Posted: | June 6, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Hematologic Neoplasms Neoplasms by Site Neoplasms Hematologic Diseases |