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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03125070
Collaborator
National Cancer Institute (NCI) (NIH)
980
Enrollment
15
Locations
2
Arms
37.8
Anticipated Duration (Months)
65.3
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice and Internet site with links to existing resources
  • Other: Internet, Mobile app and Telehealth Intervention
  • Other: Survey Administration
 Phase 3

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

Study Type:
Interventional
Anticipated 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 :
Nov 5, 2020
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (INSPIRE, survivorship care plan)

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

Other: Internet, Mobile app and Telehealth Intervention
Receive INSPIRE and survivorship care plan
Other Names:
  • Digital Intervention

    • Other: Survey Administration
    Ancillary studies
    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.

    Other: Best Practice and Internet site with links to existing resources
    Receive usual care
    Other Names:
  • best practice
  • standard of care
  • standard therapy

    • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Cancer and Treatment Distress (CTXD) [Up to 12 months]

      Assesses distress or worry level.

    2. Health Care Adherence (HCA)-cardio [Up to 12 months]

      Assesses adherence to cardiometabolic surveillance.

    3. HCA-cancer [Up to 12 months]

      Assesses adherence to subsequent malignancy surveillance.

    Secondary Outcome Measures

    1. Reach of web-based intervention [Up to 12 months]

      Rates of participants approached versus registering.

    2. Utilization of web-based intervention [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.

    3. PHQ-8 Depression [Up to 12 months]

      Assessed by patient questionnaire.

    4. PROMIS physical function [Up to 12 months]

      Assessed by patient questionnaire.

    5. Knowledge of survivorship needs [Up to 12 months]

      Assessed by patient questionnaire.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moffitt Cancer Center Tampa Florida United States 33612
    2 Loyola University Medical Center Maywood Illinois United States 60153
    3 University of Kansas Cancer Center Kansas City Kansas United States 66160
    4 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    5 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    6 National Marrow Donor Program Minneapolis Minnesota United States 55401
    7 Center for International Blood and Marrow Transplant Research Minneapolis Minnesota United States 55413-5000
    8 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    9 Roswell Park Cancer Institute Buffalo New York United States 14263
    10 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    11 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    12 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    13 Texas Oncology at Baylor Charles A Sammons Cancer Center Dallas Texas United States 75246
    14 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109
    15 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: K. Scott Baker, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03125070
    Other Study ID Numbers:
    • 9819
    • NCI-2017-00583
    • 9819
    • R01CA215134
    • RG1001537
    First Posted:
    Apr 24, 2017
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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:
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Jun 6, 2022