RecruitingNot ApplicableNCT06505590

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

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

372 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an online digital support program designed to help cancer patients and survivors manage cancer-related fatigue — a type of exhaustion that is not relieved by rest and affects daily life. The program is delivered via smartphone and is available to people in France who read French. **You may be eligible if...** - You are 18 or older with a confirmed cancer diagnosis (whether on active treatment or a survivor) - You have experienced moderate to severe fatigue for at least one week (rating 4 or more out of 10) - You can read and understand French - You have a smartphone **You may NOT be eligible if...** - You have a psychiatric or cognitive disorder that would interfere with participation - You are currently receiving cognitive-behavioral therapy - You are enrolled in another behavioral clinical trial - Your fatigue has a treatable medical cause (e.g., anemia, thyroid problem, or infection) that hasn't been addressed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEducational content

Patients will have access to educational content on the mobile app Resilience © in the format of articles, videos or podcasts on treatment related symptoms and on validated supportive care interventions. This version is currently public available in France and Belgium at www.resilience.care and is considered the control group (education only).

DEVICEEducational material plus self-management program - self-administered version

Patients will have access to the same mobile app (Resilience ©) with its educational content will be powered with a self-guided fatigue self-management program based on a cognitive behavioral therapy approach.

DEVICEEducational material plus self-management program - guided version with mental health professional

Patients will have access to the same mobile app (Resilience ©) with its educational content and the self-management program of arm 2 and weekly calls with a certified mental health professional certified in cognitive behavioural therapy for guided coaching across the self-management program.