Phase 3 N=375 Randomized Single-blind Supportive Care

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

Hematopoietic and Lymphoid Cell Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT03125070 ↗

Enrolled (actual)

375

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Cancer and Treatment Distress (CTXD) — 23.4; 22.6 percentage of participants — p=0.90

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Best Practice and Internet site with links to existing resources (Other); Internet, Mobile app and Telehealth Intervention (Other); Survey Administration (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Cancer and Treatment Distress (CTXD)	23.4; 22.6	0.90
PRIMARY Health Care Adherence (HCA)-Cardiometabolic	30.5; 27.2	0.60
PRIMARY Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks	35; 50; 33; 66; 54; 91	0.27
SECONDARY Health Care Adherence (HCA)-Subsequent Malignancy Screening	4.8; 4.2	0.89
SECONDARY PHQ-8 Depression	28.6; 39.5	0.40

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03125070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.