Clinical trial · Interventional
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)
NCT06505590CI-TRIAL-00095084STEPPING-STONerecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Decentralized, randomized hybrid type 2 (effectiveness/implementation) controlled trial comparing the effectiveness of three different digital aid modalities programs in reducing the perceived burden of CRF in cancer patients while also gathering data on the implementation strategy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Diagnosis | — | UNRESOLVED | — |
| Moderate or Severe Score of Cancer-related Fatigue (CRF) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational content | Device | — | UNRESOLVED |
| Educational material plus self-management program - guided version with mental health professional | Device | — | UNRESOLVED |
| Educational material plus self-management program - self-administered version | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- SHAM_COMPARATOR
- label
- Educational material aid tool
- description
- Educational content on the mobile app Resilience © in the format of articles, videos or podcasts on treatment related symptoms and on validated supportive care interventions.
- interventionNames
- Device: Educational content
- type
- EXPERIMENTAL
- label
- Educational material plus self-management program - self-administered version
- description
- Mobile app (Resilience ©) with its educational content plus a self-guided fatigue self-management program based on a cognitive behavioral therapy approach.
- interventionNames
- Device: Educational material plus self-management program - self-administered version
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older. * Having a clinical diagnosis of cancer including patients on active treatment or cancer survivors. * Self-reporting moderate to severe CRF for at least one week (worst level of fatigue ≥ 4 on a 10-point numerical rating scale, retained in international guidelines as an optimal cutoff for identifying clinically significant CRF). * Being able to read and understand French. * Having access to a smartphone. * Patients must be affiliated to a social security system or beneficiary of the same. Exclusion Criteria: * Suffering from current psychiatric disorder or cognitive disorder that would interfere with the ability to consent or participate. * Currently engaging in cognitive-behavioral therapy. * Currently engaging in another non-drug (behavioral) clinical trial. * Suffering from physical related reversible and treatable causes of fatigue (anemia, electrolytes unbalance, infections, renal dysfunction, active metastases causing fatigue, hormonal unbalances (hypothyroidism, adrenal insufficiency, etc.) - according to physician's judgement at the moment of inclusion.
References
Publications (1)
- DERIVEDFranzoi MA, Pages A, Charles C, Debiasi M, Gillanders E, Ferreira A, Jacques F, Everhard S, GaryBobo G, Sambou C, Alla F, Quivy A, Morin S, Vaz-Luis I. 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 Aug;155:107993. doi: 10.1016/j.cct.2025.107993. Epub 2025 Jun 26. PMID 40581251