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Clinical Trial 20067

Cancer Type: Malignant Hematology
Study Type: Supportive Care
NCT#: NCT03125070

Phase: Phase III
Prinicipal Investigator: Heather Jim

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Overview

Study Title

INSPIRE: A Multicenter Randomized Controlled Trial Integrating Health Informatics in a Scalable Stepped Care Self-Management Program for Survivors after Hematopoietic Cell Transplantation

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.

Objective

To determine the efficacy of a multicenter RCT of a self-management survivorship intervention that includes a personalized mobile application that is cross-device enabled, with internet and social media options, including stepped care telehealth, for adult 2-5 year HCT survivors enrolled from national transplant centers. Primary Aims 1. Determine whether 2-5 year HCT survivors with elevated cancer-related distress or poor health care adherence, adherence to cardiometabolic or subsequent malignancy surveillance who are randomized to receive the online, patient-centered, self-management stepped care program will report reduced distress, and improved health care adherence for cardiometabolic or subsequent malignancy surveillance at 12 months when compared with an active control group who receive access to HCT survivorship best practices. 2. Determine characteristics of intervention participants who require telehealth stepped care at 1-month, because they 1) do not meet criteria for adequate knowledge of subsequent malignancy and cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program. 3. Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR//NMDP. Secondary Aims Secondary outcomes will include process measures of internet study reach and utilization, as well as depression, physical function, physical activity level, and knowledge of survivorship needs in HCT survivors.

Treatments

Therapies

Medications

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)

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