The effectiveness and implementation of a STEpwise program to promote INGeniouS ONline supportive solutions for self-management of cancer-related fatigue: The STEPPING-STONe digitally enabled randomized trial

Maria Alice Franzoi; Arnaud Pages; Cecile Charles; Marcio Debiasi; Emma Gillanders; Arlindo Ferreira; Fanny Jacques; Sibille Everhard; Guillaume GaryBobo; Cesarine Sambou; François Alla; Amandine Quivy; Sophie Morin; Ines Vaz-Luis

doi:10.1016/j.cct.2025.107993

The effectiveness and implementation of a STEpwise program to promote INGeniouS ONline supportive solutions for self-management of cancer-related fatigue: The STEPPING-STONe digitally enabled randomized trial

Contemp Clin Trials. 2025 Jun 26:155:107993. doi: 10.1016/j.cct.2025.107993. Online ahead of print.

Authors

Affiliations

¹ Cancer Survivorship Group, Inserm Unit 981, Gustave Roussy, Villejuif, France. Electronic address: Mariaalice.borinelli-franzoi@gustaveroussy.fr.
² OncoStat, Gustave Roussy, Villejuif, France.
³ Direction general de la Cohesion sociale (DGCS), Paris, France.
⁴ Champalimaud Hospital, Lisbon, Portugal.
⁵ Cancer Survivorship Group, Inserm Unit 981, Gustave Roussy, Villejuif, France.
⁶ Resilience Care, Paris, France.
⁷ WeShare Platform, Data Department, UNICANCER, Paris, France.
⁸ Équipe PHARES, Centre de recherche Bordeaux Population Health, Inserm Unit 1219, Université de Bordeaux, France.
⁹ Supportive Care Department, CHU Bordeaux, Bordeaux, France.
¹⁰ Supportive Care Department, Institut Bergonié, Bordeaux, France.
¹¹ Cancer Survivorship Group, Inserm Unit 981, Gustave Roussy, Villejuif, France; Department for the Organization of Patient Pathways, Gustave Roussy, Villejuif, France.

PMID: 40581251
DOI: 10.1016/j.cct.2025.107993

Abstract

Background: Fatigue is one of the most common and disturbing symptoms patients face throughout the cancer care continuum, and it is sub optimally addressed in routine care. Developing effective and scalable tools for symptom management is a central unmet need for achieving comprehensive and patient-centric cancer care delivery. This study aims to evaluate the effectiveness of three digital aid modalities for cancer related fatigue (CRF) focusing on patient empowerment and self-management.

Methods: Hybrid type 2 effectiveness-implementation randomized clinical trial. A total of 372 patients diagnosed with cancer and moderate to severe self-reported CRF will be randomized 1:1:1 into one of three intervention arms: educational mobile app, educational mobile app powered with a self-guided fatigue self-management program, or educational mobile app powered with the fatigue self-management program and interactive coaching. Clinical trial procedures will benefit from a pragmatic online platform for digitally enabled research allowing eligibility screening, electronic consent, randomization and collection of patient-reported outcomes and clinical data. The primary endpoint is the difference in fatigue scores measured by the EORTC QLQ-C30 questionnaire between baseline and three months after the end of the program. Secondary endpoints include short and long-term impact on fatigue scores including fatigue subdomains, self-efficacy, overall quality of life, use of health resources, as well a detailed implementation evaluation of both the study intervention and the digitally enabled trial procedures.

Discussion: This study will provide high-level evidence on the effectiveness and implementation of digital interventions for CRF. It will also demonstrate the feasibility of using technology to streamline clinical trial procedures.

Trial registration: ClinTrials.govNCT06505590.

Keywords: Cancer-related fatigue; Decentralized clinical trials; Digital health; Digitally enabled research; Hybrid effectiveness-implementation clinical trial; Self-management support.

Associated data

ClinicalTrials.gov/NCT06505590