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

NCT ID: NCT03125070

Last Updated: 2025-01-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-29

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Hematopoietic and Lymphoid Cell Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group I (INSPIRE, survivorship care plan)

Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.

Group Type EXPERIMENTAL

Internet, Mobile app and Telehealth Intervention

Intervention Type OTHER

Receive INSPIRE and survivorship care plan

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Best Practice and Internet site with links to existing resources

Intervention Type OTHER

Receive usual care

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice and Internet site with links to existing resources

Receive usual care

Intervention Type OTHER

Internet, Mobile app and Telehealth Intervention

Receive INSPIRE and survivorship care plan

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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best practice standard of care standard therapy Digital Intervention

Eligibility Criteria

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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)
* Non-proficient in English (written and spoken)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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K. Scott Baker

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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K. Scott Baker

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

National Marrow Donor Program

Minneapolis, Minnesota, United States

Site Status

Center for International Blood and Marrow Transplant Research

Minneapolis, Minnesota, United States

Site Status

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Texas Oncology at Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

Site Status

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2017-00583

Identifier Type: REGISTRY

Identifier Source: secondary_id

9819

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA215134

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1001537

Identifier Type: OTHER

Identifier Source: secondary_id

9819

Identifier Type: -

Identifier Source: org_study_id

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