💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Educational content
- Educational material plus self-management program - self-administered version
- Educational material plus self-management program - guided version with mental health professional
Gustave Roussy
Villejuif, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky