NCT06505590 STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
| NCT ID | NCT06505590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Cancer Diagnosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 372 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 372 participants in total. It began in 2025-09-01 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06505590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Diagnosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06505590 currently recruiting?
Yes, NCT06505590 is actively recruiting participants. Contact the research team at ines-maria.vaz-duarte-luis@gustaveroussy.fr for enrollment information.
Where is the NCT06505590 trial being conducted?
This trial is being conducted at Villejuif, France.
Who is sponsoring the NCT06505590 clinical trial?
NCT06505590 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 372 participants.
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