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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Educational content
  • Educational material plus self-management program - self-administered version
  • Educational material plus self-management program - guided version with mental health professional

Treatment groups

372 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

University Hospital, Bordeaux

Collaborator

Institut Bergonié

Collaborator