NCT06505590Recruiting
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)
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 372 (estimated)
- First submitted
- 11 Jul 2024
- Start date
- 1 Sept 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- NCT number
- NCT06505590
What you commit to
- Study type: Interventional
- Planned participants: 372
- From 1 Sept 2025 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently engaging in cognitive-behavioral therapy.
- Currently engaging in another non-drug (behavioral) clinical trial.
Other illness
- Suffering from current psychiatric disorder or cognitive disorder that would interfere with the ability to consent or participate.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.