Cancer DiagnosisSTEPPING-STONeNCT06505590
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
A study testing Educational content, Educational material plus self-management program - self-administered version and Educational material plus self-management program - guided version with mental health professional in people with Cancer Diagnosis and Moderate or Severe Score of Cancer-related Fatigue (CRF), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
- What is being tested?
- Educational content, Educational material plus self-management program - self-administered version and Educational material plus self-management program - guided version with mental health professional
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, 94805
Ines VAZ-LUIS, MD, +33 (0)1 42 11 48 27, ines-maria.vaz-duarte-luis@gustaveroussy.fr
Maria Alice FRAZOI, MD, +33 (0)1 42 11 48 27, mariaalice.borinelli-franzoi@gustaveroussy.fr
About this study
Official title: 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.
- Being tested
- Educational content, Educational material plus self-management program - self-administered version, Educational material plus self-management program - guided version with mental health professional
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational contentDevice
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).
Educational material plus self-management program - self-administered versionDevice
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.
Educational material plus self-management program - guided version with mental health professionalDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational material aid tool | Sham comparator | 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. Receives: Device: Educational content |
| Educational material plus self-management program - self-administered version | Experimental | Mobile app (Resilience ©) with its educational content plus a self-guided fatigue self-management program based on a cognitive behavioral therapy approach. Receives: Device: Educational material plus self-management program - self-administered version |
| Educational material plus self-management program - guided version with mental health professional | Experimental | 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. Receives: Device: Educational material plus self-management program - guided version with mental health professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months and 6 months after the end of the program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Institut Bergonié
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505590
- Sponsor's protocol ID
- 2023-A02082-43
- Other IDs
- 2023/3717
- Acronym
- STEPPING-STONe
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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;155:107993. doi: 10.1016/j.cct.2025.107993. Epub 2025 Jun 26.
PubMed 40581251
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)
- ClinicalTrials.gov ID
- NCT06505590
- Acronym / sponsor ID
- STEPPING-STONe / 2023-A02082-43
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Institut Bergonié
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Educational material aid tool | Sham comparator | Device: Educational contentEducational 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 | Experimental | Device: Educational material plus self-management program - self-administered versionMobile 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 | Experimental | Device: Educational material plus self-management program - guided version with mental health professionalMobile 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational contentPatients 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 aid tool |
| Educational material plus self-management program - self-administered versionPatients 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 - self-administered version |
| Educational material plus self-management program - guided version with mental health professionalPatients 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. | Device | Educational material plus self-management program - guided version with mental health professional |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 40581251Franzoi 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational content, Educational material plus self-management program - self-administered version and Educational material plus self-management program - guided version with mental health professional in people with Cancer Diagnosis and Moderate or Severe Score of Cancer-related Fatigue (CRF), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines VAZ-LUIS, MD (+33 (0)1 42 11 48 27, ines-maria.vaz-duarte-luis@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.