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

Overview

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.

Full Title of Study: “INSPIRE: A Multicenter Randomized Controlled Trial Integrating Health Informatics in a Scalable Stepped Care Self-Management Program for Survivors After Hematopoietic Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 30, 2023

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.

Interventions

  • Other: Best Practice and Internet site with links to existing resources
    • Receive usual care
  • Other: Internet, Mobile app and Telehealth Intervention
    • Receive INSPIRE and survivorship care plan
  • Other: Survey Administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Group I (INSPIRE, survivorship care plan)
    • Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
  • 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.

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fred Hutchinson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • K. Scott Baker, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium

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