Phase 3
Completed N=375
Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant
Hematopoietic and Lymphoid Cell Neoplasm
Source: ClinicalTrials.gov NCT03125070 ↗
Enrolled (actual)
375
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Cancer and Treatment Distress (CTXD) — 23.4; 22.6 percentage of participants — p=0.90
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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)
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. Informational only — not medical advice.