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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 3

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03125070

RG1001537 (Other Identifier)

R01CA215134 (U.S. NIH Grant/Contract)

NCI-2017-00583 (Registry Identifier)

9819

Details and patient eligibility

About

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 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.

Enrollment: 546 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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546 participants in 2 patient groups

Group I (INSPIRE, survivorship care plan)

Experimental group

Description:

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

Treatment:

Other: Internet, Mobile app and Telehealth Intervention

Other: Survey Administration

Group II (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Best Practice and Internet site with links to existing resources

Other: Survey Administration