Status:
RECRUITING
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
University Hospital, Bordeaux
Institut Bergonié
Conditions:
Cancer Diagnosis
Moderate or Severe Score of Cancer-related Fatigue (CRF)
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT06505590
Start Date
September 1 2025
End Date
November 1 2027
Last Update
September 15 2025
Active Locations (1)
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1
Gustave Roussy
Villejuif, France, 94805