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

Phase 3

Completed

Interventions: Other: Internet, Mobile app and Telehealth Intervention
Other: Best Practice and Internet site with links to existing resources
Other: Survey Administration

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.

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Group I (INSPIRE, survivorship care plan)	Survey Administration	Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Group II (usual care)	Survey Administration	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 I (INSPIRE, survivorship care plan)	Internet, Mobile app and Telehealth Intervention	Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
Group II (usual care)	Best Practice and Internet site with links to existing resources	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.

Primary Outcome Measures

Name	Time	Method
Cancer and Treatment Distress (CTXD)	Up to 12 months	Among those impaired at baseline, percent who are no longer impaired at 12 months (among those not missing either). Scores range from 0-3 and higher scores indicate higher distress. A cutoff of \>=.90 was used to categorize participants as high in distress. Participants with scores \<.90 were categorized as not distressed.
Health Care Adherence (HCA)-Cardiometabolic	Up to 12 months	Assesses adherence to cardiometabolic surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. Scores range from 0-1. Higher scores indicate high adherence. A cutoff of \<.80 was used to categorize participants as low in adherence. Scores higher than .80 were classified as being adherent to cardiometabolic surveillance.
Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks	6-weeks after enrollment.	Determine characteristics of participants who 1) do not meet criteria for adequate knowledge of cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program.

Secondary Outcome Measures

Name	Time	Method
Health Care Adherence (HCA)-Subsequent Malignancy Screening	Up to 12 months	Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months.
PHQ-8 Depression	Up to 12 months	Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months

Locations (15): Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Pennsylvania/Abramson Cancer Center
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Philadelphia, Pennsylvania, United States
Texas Oncology at Baylor Charles A Sammons Cancer Center
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Dallas, Texas, United States
Fred Hutch/University of Washington Cancer Consortium
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Seattle, Washington, United States
University of Kansas Cancer Center
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Kansas City, Kansas, United States
Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
National Marrow Donor Program
🇺🇸
Minneapolis, Minnesota, United States
Center for International Blood and Marrow Transplant Research
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Minneapolis, Minnesota, United States
Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, United States
University of Minnesota/Masonic Cancer Center
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Minneapolis, Minnesota, United States
Roswell Park Cancer Institute
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Buffalo, New York, United States
UNC Lineberger Comprehensive Cancer Center
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Chapel Hill, North Carolina, United States