STEPwise program promoting ingenious online supportive solutions for cancer-related fatigue
Official title: STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)
Run by Gustave Roussy, Cancer Campus, Grand Paris · NCT06505590 · Data updated 2026-11-12
This trial tests three French-language digital programs to see if they reduce bothersome cancer-related fatigue in adults with cancer who report moderate to severe fatigue.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 372 (estimated) |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Locations | 1 site (Villejuif) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06505590 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a clinical cancer diagnosis or cancer survivors who self-report moderate to severe cancer-related fatigue (worst fatigue ≥4/10), can read French, have a smartphone, and are affiliated with a social security system.
✕Probably not a fit
Patients with current psychiatric or cognitive disorders that impair participation, those receiving cognitive-behavioral therapy or enrolled in another behavioral trial, or those with reversible physical causes of fatigue or without French-language/smartphone access are unlikely to benefit from these interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This decentralized, randomized hybrid type 2 trial compares three digital aid approaches: educational content alone, an educational plus self-administered self-management program, and an educational plus guided self-management program with a mental health professional. Participants are adults with a cancer diagnosis or cancer survivors who report moderate to severe cancer-related fatigue and have access to a smartphone. The trial measures changes in perceived fatigue burden while also collecting data on how the programs are implemented and used in real-world settings. Enrollment is conducted from French clinical sites with remote delivery of the digital interventions to maximize accessibility.
Why it matters
Potential benefit: If successful, the programs could reduce the burden of cancer-related fatigue and provide scalable, remote support options for patients.
How similar studies have gone: Previous research shows that digital and CBT-based self-management programs can reduce cancer-related fatigue, with guided interventions generally showing stronger and more consistent benefits than unguided formats.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Gustave Roussy
Villejuif, France Recruiting
Study contacts
- Study coordinator: Ines VAZ-LUIS, MD
- Email: ines-maria.vaz-duarte-luis@gustaveroussy.fr
- Phone: +33 (0)1 42 11 48 27
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.