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

September 12, 2025 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Educational material aid tool
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.
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).
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
3 months and 6 months after the end of the program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

Institut Bergonié
University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A02082-43
  • 2023/3717 (Other Identifier: CSET number (Gustave Roussy ID))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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