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Recruiting NCT06505590

STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue

Conditions: Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 372
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Location: Gustave Roussy Villejuif

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06505590). StuddyBuddy aggregates publicly available trial information.