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Recruiting NCT06505590

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

No phase Interventional Cancer Diagnosis Moderate or Severe Score of Cancer-related Fatigue (CRF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational content, Educational material plus self-management program - self-administered version, Educational material plus self-management program - guided version with mental health professional.
Who it may be relevant to
Registry conditions: Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Educational 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).
  • Device Educational 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.
  • Device Educational 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.

Primary outcome measures

  • Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient. [Time frame: 3 months and 6 months after the end of the program.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Gustave Roussy — Villejuif

Publications

  • Franzoi MA, Pages A, Charles C, Debiasi M, Gillanders E, Ferreira A, Jacques F, Everhard S, GaryBobo G, Sambou C, Alla F, Quivy A, Morin S, Vaz-Luis I. The effectiveness and implementation of a STEpwise Program to Promote INGeniouS ONline supportive solutions for self-management of cancer-related fatigue: The STEPPING-STONe digitally enabled randomized trial. Contemp Clin Trials. 2025 Aug;155:1079 PMID 40581251

Identifiers

NCT: NCT06505590 · 2023-A02082-43 · 2023/3717

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗