STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
STEPPING-STONe
2 other identifiers
interventional
372
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2024
CompletedFirst Posted
Study publicly available on registry
July 17, 2024
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
September 15, 2025
September 1, 2025
2.2 years
July 11, 2024
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient.
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.
Study Arms (3)
Educational material aid tool
SHAM COMPARATOREducational content on the mobile app Resilience © in the format of articles, videos or podcasts on treatment related symptoms and on validated supportive care interventions.
Educational material plus self-management program - self-administered version
EXPERIMENTALMobile app (Resilience ©) with its educational content plus a self-guided fatigue self-management program based on a cognitive behavioral therapy approach.
Educational material plus self-management program - guided version with mental health professional
EXPERIMENTALMobile 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.
Interventions
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).
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gustave Roussy, Cancer Campus, Grand Parislead
- University Hospital, Bordeauxcollaborator
- Institut Bergoniécollaborator
Study Sites (1)
Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
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;155:107993. doi: 10.1016/j.cct.2025.107993. Epub 2025 Jun 26.
PMID: 40581251DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2024
First Posted
July 17, 2024
Study Start
September 1, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share