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

Not Applicable

Not yet recruiting

• Conditions: Moderate or Severe Score of Cancer-related Fatigue (CRF); Cancer Diagnosis
• Interventions: Device: Educational material plus self-management program - guided version with mental health professional; Device: Educational material plus self-management program - self-administered version; Device: Educational content

• Registration Number: NCT06505590
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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 of CRF in cancer patients while also gathering data on the implementation strategy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Start: 2025-04
• Primary Completion: 2025-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 372

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational material plus self-management program - guided version with mental health professional	Educational material plus self-management program - guided version with mental health professional	Mobile app (Resilience ©) with its educational content and the self-management program of arm 2 plus weekly calls with a certified mental health professional certified in cognitive behavioural therapy for guided coaching across the self-management program.
Educational material plus self-management program - self-administered version	Educational material plus self-management program - self-administered version	Mobile app (Resilience ©) with its educational content plus a self-guided fatigue self-management program based on a cognitive behavioral therapy approach.
Educational material aid tool	Educational content	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.

Primary Outcome Measures

Name	Time	Method
Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient.	3 months and 6 months after the end of the program.	Compare the effectiveness of standard of care (provided by the patient's cancer center and their treating oncologist) plus three different types of digital aid modalities for the patient (1: educational material; 2: educational material plus self-management program based on a cognitive behavioural therapy strategy - self-administered; 3: educational material plus self-management program based on a cognitive behavioural therapy strategy - guided by a psychologist) in reducing the perceived burden of CRF (cancer-related fatigue), measured as a clinically meaningful change (≥ 6 points) in fatigue scores in the fatigue subscale of the EORTC QLQ C30 questionnaire from baseline to short-term assessments.

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France